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CHAPTER 4 – SAMPLE 

4.1 – GENERAL ..................................................................................................................................................... 4-9

4.1.1 – PURPOSE – WHY DO WE COLLECT SAMPLES? ...................................................................................................... 4-9

4.1.1.1 – WHAT IS A VALID SAMPLE? ....................................................................................................................................... 4-9

4.1.1.2 – WHAT ARE YOUR RESPONSIBILITIES WHEN COLLECTING A VALID SAMPLE? ....................................................................... 4-10

4.1.1.3 – PERSONAL SAFETY WHILE COLLECTING SAMPLES ........................................................................................................ 4-10

4.1.2 – AUTHORITY TO COLLECT SAMPLES ................................................................................................................... 4-11

4.1.3 – RESPONSIBLE PARTIES .................................................................................................................................. 4-11

4.1.3.1 – DEALER............................................................................................................................................................... 4-11

4.1.3.2 – MANUFACTURER .................................................................................................................................................. 4-11

4.1.3.3 – SHIPPER .............................................................................................................................................................. 4-12

4.1.3.4 – CARRIER.............................................................................................................................................................. 4-12

4.1.4 – OFFICIAL SAMPLES ...................................................................................................................................... 4-12

4.1.4.1 – DOCUMENTARY SAMPLES (DOC SAMPLES) ............................................................................................................... 4-13

4.1.4.1.1 – What is a documentary official sample (DOC sample)? ............................................................................... 4-13

4.1.4.1.2 - When Should You Collect a DOC Sample instead of an Actual Physical Sample of the Product?................. 4-14

4.1.4.2 – PHYSICAL SAMPLES ............................................................................................................................................... 4-15

4.1.4.2.1 – In-transit sample........................................................................................................................................... 4-15

4.1.4.2.2 – 301(k) sample ............................................................................................................................................... 4-15

4.1.4.2.3 – Post-Seizure (PS) sample .............................................................................................................................. 4-16

4.1.4.2.4 – Import sample............................................................................................................................................... 4-16

4.1.4.2.4.1 – Special Domestic Import Sample (SDI) ...................................................................................................... 4-16

4.1.4.2.4.2 – Mail Entry sample ...................................................................................................................................... 4-17

4.1.4.2.5 – Domestic import sample (DI)........................................................................................................................ 4-17

4.1.4.2.6 – Additional Sample......................................................................................................................................... 4-17

4.1.4.2.7 – Reconditioning sample ................................................................................................................................. 4-18

4.1.4.2.8 – Audit/Certification sample............................................................................................................................ 4-18

4.1.4.2.9 – Induced Samples........................................................................................................................................... 4-18

4.1.4.2.10 – Undercover Samples (Commonly Known As Undercover Buys)................................................................. 4-18

4.1.4.2.11 – Online Samples........................................................................................................................................... 4-19

4.1.5 – INVESTIGATIONAL SAMPLES (INV) .................................................................................................................. 4-19

4.1.6 – SURVEY SAMPLES........................................................................................................................................ 4-20

4.1.7 – NON-REGULATORY SAMPLE........................................................................................................................... 4-20

4.2 – DEALER INTERACTIONS.............................................................................................................................. 4-20

4.2.1 – DEALER DEFINITION AND GOOD WILL .............................................................................................................. 4-20

4.2.2 – DEALER OBJECTION TO SAMPLING PROCEDURE .................................................................................................. 4-21

4.2.3 – REFUSAL TO PERMIT SAMPLING...................................................................................................................... 4-21

4.2.3.1 – LIMITING OR PREVENTING COLLECTION OF SAMPLES OF A DRUG .................................................................................. 4-21

4.2.4 – CARRIER IN-TRANSIT SAMPLING ..................................................................................................................... 4-22

4.2.5 – RECEIPT FOR SAMPLES.................................................................................................................................. 4-22

4.2.5.1 – CARRIERS/IN-TRANSIT LOTS ................................................................................................................................... 4-22

4.2.5.2 – DEALER REQUESTS RECEIPT .................................................................................................................................... 4-22

4.2.5.3 – NARCOTIC AND CONTROLLED RX DRUGS .................................................................................................................. 4-22

4.2.5.4 – PRESCRIPTION DRUGS (NON-CONTROLLED) .............................................................................................................. 4-23

4.2.5.5 – PREPARATION OF FDA 484.................................................................................................................................... 4-23

4.2.5.6 – ROUTING OF FDA 484 .......................................................................................................................................... 4-23

4.2.6 – DEALER IDENTIFICATION OF LOT AND RECORDS .................................................................................................. 4-23

4.2.6.1 – PRIVATE INDIVIDUALS............................................................................................................................................ 4-23
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4.2.6.2 – SERIOUSLY ILL INDIVIDUALS .................................................................................................................................... 4-23

4.2.7 – SAMPLING FROM OTHER GOVERNMENT AGENCIES.............................................................................................. 4-23

4.2.8 – PAYMENT FOR SAMPLES ............................................................................................................................... 4-23

4.2.8.1 – POST SEIZURE (PS) AND RECONDITIONING SAMPLES UNDER COURT ORDER................................................................... 4-24

4.2.8.2 – DETERMINING SAMPLE COST.................................................................................................................................. 4-24

4.2.8.3 - METHOD OF PAYMENT........................................................................................................................................... 4-24

4.2.8.3.1 - Costs Billed to Division .................................................................................................................................. 4-24

4.2.8.3.2 - Cash Payment................................................................................................................................................ 4-25

4.2.8.3.3 - Online Payment............................................................................................................................................. 4-25

4.2.8.4 – SAMPLING – LABOR CHARGES................................................................................................................................. 4-25

4.2.9 – DEALER VOLUNTARY HOLD............................................................................................................................ 4-26

4.2.9.1 – PERISHABLE GOODS .............................................................................................................................................. 4-26

4.2.9.2 – OBTAINING A VOLUNTARY HOLD............................................................................................................................. 4-26

4.3 - COLLECTION TECHNIQUE ............................................................................................................................ 4-27

4.3.1 - LOT RESTORATION AND IDENTIFICATION............................................................................................................ 4-27

4.3.1.1 - RESTORING LOT(S) SAMPLED................................................................................................................................... 4-27

4.3.1.2 - IDENTIFYING LOT(S) SAMPLED ................................................................................................................................. 4-27

4.3.2 - SAMPLE SIZE............................................................................................................................................... 4-28

4.3.2.1 - MEDICAL DEVICE SAMPLES ..................................................................................................................................... 4-28

4.3.2.2 - 702(B) REQUIREMENT ........................................................................................................................................... 4-28

4.3.2.3 - COLLECTING THE 702(B) PORTION ........................................................................................................................... 4-29

4.3.3 - IN-TRANSIT SAMPLES.................................................................................................................................... 4-29

4.3.3.1- EXAMINATION WITHOUT A WARRANT ....................................................................................................................... 4-29

4.3.3.2 - EXAMINATION WITH A WARRANT............................................................................................................................. 4-30

4.3.3.3 - RESEALING CONVEYANCES ...................................................................................................................................... 4-30

4.3.4 - SPECIAL SAMPLING SITUATIONS ...................................................................................................................... 4-30

4.3.4.1 - SAMPLES COLLECTED DURING INVESTIGATIONS OF COMPLAINTS, COUNTERFEITING, TAMPERING, FOODBORNE DISEASE, AND/OR 

INJURY/ILLNESS................................................................................................................................................................... 4-31

4.3.4.2 - UNDERCOVER BUY SAMPLES ................................................................................................................................... 4-31

4.3.4.3 - COLLECTING SURVEILLANCE SAMPLES ON FARMS........................................................................................................ 4-32

4.3.4.4 - COLLECTING FEED SAMPLES FOR BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) ANALYSIS .............................................. 4-33

4.3.4.5 – COLLECTING SAMPLES DURING FOREIGN INSPECTIONS................................................................................................ 4-34

4.3.4.6 – NOTIFICATION FOR FDA SAMPLES COLLECTED DURING A FOREIGN ESTABLISHMENT INSPECTION OR DURING FDA ACTIVITIES IN A 

U.S. TERRITORY OUTSIDE OF THE CUSTOMS TERRITORY OF THE UNITED STATES ............................................................................ 4-34

4.3.5 - ASEPTIC SAMPLE.......................................................................................................................................... 4-35

4.3.5.1 - GENERAL PROCEDURES........................................................................................................................................... 4-35

4.3.5.1.1 - Sterilized Equipment ..................................................................................................................................... 4-36

4.3.5.1.2 - CAUTIONS ...................................................................................................................................................... 4-36

4.3.5.1.3 - Opening Sterile Sampling Containers............................................................................................................ 4-36

4.3.5.1.4 - Dusty Areas.................................................................................................................................................... 4-36

4.3.5.2 - SAMPLING DRIED POWDERS.................................................................................................................................... 4-36

4.3.5.2.1 - Bag And Poly-Liner Stitched Together Across Top Seam............................................................................... 4-37

4.3.5.2.2 - Bag Stitched Across Top And Poly-Liner Twist-Closed And Sealed With "Twist" Device - Wire, Plastic, Etc. 4-37

4.3.5.2.3 - Bags With Filling Spouts ................................................................................................................................ 4-37

4.3.5.3 - COLLECTING WATER SAMPLES................................................................................................................................. 4-37

4.3.5.4 - SAMPLE HANDLING................................................................................................................................................ 4-38

4.3.5.5 – CLOSED CONTROLS ............................................................................................................................................... 4-38

4.3.6 – DOCUMENTING FILTH AND OTHER CONTAMINATION ........................................................................................... 4-39

4.3.6.1 - FIELD EXAMINATION TO DOCUMENT CONTAMINATION................................................................................................ 4-39

4.3.6.2 - RANDOM SAMPLING.............................................................................................................................................. 4-40

4.3.6.3 - SELECTIVE SAMPLING ............................................................................................................................................. 4-40
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4.3.6.4 - ABNORMAL CONTAINERS........................................................................................................................................ 4-40

4.3.6.5 - MICROBIOLOGICAL SAMPLES................................................................................................................................... 4-41

4.3.6.5.1 – Collection Of Samples For Molds.................................................................................................................. 4-41

4.3.6.6 – COLLECTION OF ENVIRONMENTAL AND PRODUCT SAMPLES FOR FOOD SUSCEPTIBLE TO CONTAMINATION WITH PATHOGENIC 

MICROORGANISMS.............................................................................................................................................................. 4-41

4.3.6.6.1 - Environmental Sampling................................................................................................................................ 4-42

4.3.6.6.2 - Environmental Sampling Equipment and Instructions For Large and Small Area Environmental Surface 

Sampling ......................................................................................................................................................................... 4-44

4.3.6.6.3 – In-Line Sampling/Factory Food Sample ........................................................................................................ 4-48

4.3.6.6.4 - Finished Product Sampling ............................................................................................................................ 4-49

4.3.6.6.5 - Reporting Environmental Sampling Results on the FDA 483 ........................................................................ 4-49

4.3.6.7 - SAMPLES FOR VIRAL ANALYSIS................................................................................................................................. 4-50

4.3.7 - ECONOMIC VIOLATIONS ................................................................................................................................ 4-50

4.3.7.1 – NET WEIGHT AND VOLUME DETERMINATIONS .......................................................................................................... 4-50

4.3.7.2 ECONOMIC LABELING............................................................................................................................................... 4-50

4.3.8 - ORGANOLEPTIC EXAMINATIONS ...................................................................................................................... 4-51

4.3.8.1 - WHOLE-BAG SCREENING........................................................................................................................................ 4-51

4.4 – DOCUMENTS COLLECTED WITH SAMPLE..................................................................................................... 4-51

4.4.1 – GENERAL CONSIDERATIONS/PROCEDURES REGARDING DOCUMENTS ....................................................................... 4-51

4.4.2 – IDENTIFYING SAMPLE RECORDS ...................................................................................................................... 4-52

4.4.3 - EVIDENCE REQUIRED .................................................................................................................................... 4-52

4.4.3.1 – GENERAL CONSIDERATIONS FOR EVIDENCE ............................................................................................................... 4-53

4.4.3.1.1 - Introduction into Interstate Commerce (FD&C Act 301(a) and 301(d) charges) .......................................... 4-53

4.4.3.1.2 - Adulteration or Misbranding in Interstate Commerce (FD&C Act 301(b) charges)...................................... 4-53

4.4.3.1.3 - Receipt in Interstate Commerce (FD&C Act 301(c) charges) ........................................................................ 4-54

4.4.3.1.4 - Manufacture Within a Territory (FD&C Act 301(g) charges)......................................................................... 4-54

4.4.3.1.5 - False Guaranty (FD&C Act 301(h) charges) ................................................................................................... 4-54

4.4.3.1.6 - Dealer Violation (FD&C Act 301(k) charges).................................................................................................. 4-54

4.4.3.2 – EVIDENCE FOR SEIZURE, INJUNCTION OR CRIMINAL PROSECUTION................................................................................ 4-55

4.4.3.3 - COMPLAINT OR INJURY SAMPLES ............................................................................................................................. 4-55

4.4.4 - DOCUMENTING INTERSTATE SHIPMENTS............................................................................................................ 4-55

4.4.4.1 - SALES RECORDS..................................................................................................................................................... 4-55

4.4.4.2 - TRANSPORTATION RECORDS FOR COMMON CARRIER SHIPMENTS.................................................................................. 4-56

4.4.4.2.1 - Refusal To Permit Access To Records In Possession Of Common Carriers.................................................... 4-56

4.4.4.2.2 - Written Request For Records........................................................................................................................ 4-56

4.4.4.2.3 - Bill of Lading .................................................................................................................................................. 4-57

4.4.4.2.4 - Freight Bill...................................................................................................................................................... 4-57

4.4.4.2.5 – Waybill .......................................................................................................................................................... 4-57

4.4.4.3 - MAIL OR PARCEL SERVICE SHIPMENTS ...................................................................................................................... 4-57

4.4.4.4 - SHIPMENT BY PRIVATELY-OWNED CONVEYANCE......................................................................................................... 4-58

4.4.4.5 - FORM FDA 1662, COPY OF INVOICE/SHIPPING RECORD ............................................................................................. 4-58

4.4.5 – AFFIDAVITS................................................................................................................................................ 4-58

4.4.5.1 - GENERAL CONSIDERATIONS FOR ALL AFFIDAVITS......................................................................................................... 4-58

4.4.5.2 – AFFIDAVITS FOR NON-ENGLISH OR LIMITED ENGLISH PROFICIENCY SPEAKERS................................................................. 4-59

4.4.5.3 - REFUSAL TO SIGN THE AFFIDAVIT ............................................................................................................................. 4-60

4.4.5.4 - CONFIDENTIAL INFORMANTS ................................................................................................................................... 4-60

4.4.5.5 - AFFIDAVIT (DEALER/WAREHOUSEMAN FDA 1664).................................................................................................... 4-60

4.4.5.6 - AFFIDAVIT (FDA 463A) .......................................................................................................................................... 4-60

4.4.5.7 - AFFIDAVIT (JOBBER FDA 1664A) ............................................................................................................................. 4-61

4.4.5.8 – AFFIDAVIT (PARCEL POST/SERVICE FDA 463)........................................................................................................... 4-61

4.4.5.9 – AFFIDAVIT (IN-TRANSIT SAMPLING FDA 1664B) ....................................................................................................... 4-61
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4.4.6 – DOCUMENTING SAMPLE MANUFACTURING ....................................................................................................... 4-61

4.4.7 - LABELS AND LABELING .................................................................................................................................. 4-62

4.4.7.1 – DEFINITION: LABELS AND ACCOMPANYING LABELING.................................................................................................. 4-63

4.4.7.2 – COLLECTION: LABELS AND ACCOMPANYING LABELING................................................................................................. 4-63

4.4.7.2 - BULK SHIPMENTS .................................................................................................................................................. 4-64

4.4.7.3 - UNLABELED OR PARTIALLY LABELED LOT.................................................................................................................... 4-64

4.4.7.3.1 - Documentation.............................................................................................................................................. 4-64

4.5 - BIORESEARCH MONITORING (BIMO) SAMPLES............................................................................................ 4-64

4.5.1 - BIMO AFFIDAVITS ....................................................................................................................................... 4-65

4.5.2 - BIMO COLLECTION REPORTS (C/RS) ................................................................................................................ 4-65

4.5.3 - SAMPLE TYPE.............................................................................................................................................. 4-65

4.5.4 - SAMPLE DESCRIPTION................................................................................................................................... 4-65

4.5.5 - REASON FOR COLLECTION .............................................................................................................................. 4-65

4.5.6 - ASSOCIATED FIRMS ...................................................................................................................................... 4-65

4.5.7 - PRODUCT CODE AND PRODUCT NAME .............................................................................................................. 4-65

4.5.8 - BRAND NAME............................................................................................................................................. 4-65

4.5.9 - PRODUCT LABEL .......................................................................................................................................... 4-66

4.5.10 - SAMPLE FLAGS .......................................................................................................................................... 4-66

4.5.11 - ESTIMATED VALUE ..................................................................................................................................... 4-66

4.5.12 – C/R & RECORDS SENT TO FACTS ORG .......................................................................................................... 4-66

4.5.13 - BA/BE SAMPLE SHIPMENT .......................................................................................................................... 4-66

4.6 – REPORTING SAMPLE COLLECTIONS (COMPLETING YOUR C/R)..................................................................... 4-66

4.6.1 – SAMPLE TYPE ............................................................................................................................................. 4-67

4.6.1.1 – ADDITIONAL SAMPLE (ADD) .................................................................................................................................. 4-67

4.6.1.2 - AUDIT/CERTIFICATION............................................................................................................................................ 4-67

4.6.1.3 - DOCUMENTARY (DOC) .......................................................................................................................................... 4-67

4.6.1.4 - DOMESTIC IMPORT (DI) ......................................................................................................................................... 4-68

4.6.1.5 - FOOD STANDARDS (FS).......................................................................................................................................... 4-68

4.6.1.6 - INVESTIGATIONAL (INV)......................................................................................................................................... 4-68

4.6.1.7 - MAIL ENTRY ......................................................................................................................................................... 4-68

4.6.1.8 - NON-REGULATORY ................................................................................................................................................ 4-68

4.6.1.9 – OFFICIAL ............................................................................................................................................................. 4-68

4.6.1.10 - POST AWARD ..................................................................................................................................................... 4-68

4.6.1.11 – POST-SEIZURE (PS)............................................................................................................................................. 4-68

4.6.1.12 - REGULATORY ...................................................................................................................................................... 4-68

4.6.2 – PREPARATION ............................................................................................................................................ 4-68

4.6.2.1 - ACCOMPLISHMENT HOURS ..................................................................................................................................... 4-69

4.6.2.2 - ANALYTICAL ASSIGNMENT....................................................................................................................................... 4-69

4.6.2.3 - BRAND NAME....................................................................................................................................................... 4-69

4.6.2.4 - CARRIER NAME ..................................................................................................................................................... 4-69

4.6.2.5 - COLLECTION DATE (DATE COLLECTED) ...................................................................................................................... 4-69

4.6.2.6 - COLLECTION METHOD (METHOD OF COLLECTION) ...................................................................................................... 4-70

4.6.2.7 - COLLECTION PACS................................................................................................................................................. 4-70

4.6.2.8 - COLLECTION REASON (REASON FOR COLLECTION) ....................................................................................................... 4-70

4.6.2.9 - COLLECTION REMARKS ........................................................................................................................................... 4-70

4.6.2.10 – COLLECTOR........................................................................................................................................................ 4-71

4.6.2.11 - COLLECTOR'S ID ON PACKAGE/DOCUMENT ............................................................................................................. 4-71

4.6.2.12 - COLLECTOR'S ID ON SEAL ..................................................................................................................................... 4-71

4.6.2.13 - CONSUMER COMPLAINT NUMBER.......................................................................................................................... 4-71

4.6.2.14 - COUNTRY OF ORIGIN ........................................................................................................................................... 4-71

4.6.2.15 – COUNTY............................................................................................................................................................ 4-72
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4.6.2.16 – C/R & RECORDS SENT TO (ORIG C/R & RECORDS TO)............................................................................................. 4-72

4.6.2.17 – CONTROLLED PRESCRIPTIONS AND DRUG SCHEDULING ............................................................................................. 4-72

4.6.2.18 - DAIRY PERMIT NUMBER (PERMIT NUMBER)............................................................................................................ 4-72

4.6.2.19 - DATE SHIPPED .................................................................................................................................................... 4-72

4.6.2.20 - DOCUMENTS OBTAINED ....................................................................................................................................... 4-72

4.6.2.21 - EPISODE NUMBER ............................................................................................................................................... 4-73

4.6.2.22 - ESTIMATED VALUE............................................................................................................................................... 4-73

4.6.2.23 - FEI NUMBER ...................................................................................................................................................... 4-73

4.6.2.24 - FIRM NAME........................................................................................................................................................ 4-73

4.6.2.25 - FIRM TYPE.......................................................................................................................................................... 4-73

4.6.2.25.1 – Dealer.......................................................................................................................................................... 4-73

4.6.2.25.2 – Grower........................................................................................................................................................ 4-73

4.6.2.25.3 – Harvester .................................................................................................................................................... 4-73

4.6.2.25.4 - Ingredient Supplier...................................................................................................................................... 4-74

4.6.2.25.5 – Manufacturer.............................................................................................................................................. 4-74

4.6.2.25.6 – Repacker..................................................................................................................................................... 4-74

4.6.2.25.7 – Shipper........................................................................................................................................................ 4-74

4.6.2.26 - FIS SAMPLE NUMBER .......................................................................................................................................... 4-74

4.6.2.27 – FLAG ................................................................................................................................................................ 4-74

4.6.2.27.1 - 301(K) Sample.............................................................................................................................................. 4-74

4.6.2.27.2 - Complaint Sample........................................................................................................................................ 4-74

4.6.2.27.3 - Dealer Voluntarily Holding .......................................................................................................................... 4-74

4.6.2.27.4 - Exhibit Sample ............................................................................................................................................. 4-74

4.6.2.27.5 - Factory Food Sample ................................................................................................................................... 4-75

4.6.2.27.6 – Fumigated................................................................................................................................................... 4-75

4.6.2.27.7 - Inv. Samples Of Filth Exhibits ...................................................................................................................... 4-75

4.6.2.27.8 - Pesticide Sample.......................................................................................................................................... 4-75

4.6.2.27.9 – Produce Related Result Requested ............................................................................................................ 4-76

4.6.2.27.10 – Public Land Sample................................................................................................................................... 4-76

4.6.2.27.11 – Reconditioned........................................................................................................................................... 4-76

4.6.2.27.12 - Split Sample ............................................................................................................................................... 4-76

4.6.2.27.13 - Survey Sample ........................................................................................................................................... 4-76

4.6.2.27.14 - Under State Embargo ................................................................................................................................ 4-76

4.6.2.28 - FOOD CANNING ESTABLISHMENT ........................................................................................................................... 4-77

4.6.2.29 - HOURS .............................................................................................................................................................. 4-77

4.6.2.30 - HOW PREPARED.................................................................................................................................................. 4-77

4.6.2.31 - LOT SIZE ............................................................................................................................................................ 4-77

4.6.2.32 - MANUFACTURING CODES ..................................................................................................................................... 4-77

4.6.2.33 - NATIONAL DRUG CODE (NDC).............................................................................................................................. 4-77

4.6.2.34 - PAYMENT METHOD ............................................................................................................................................. 4-78

4.6.2.35 - PRODUCT CODE .................................................................................................................................................. 4-78

4.6.2.36 - PRODUCT DESCRIPTION........................................................................................................................................ 4-78

4.6.2.37 - PRODUCT LABEL .................................................................................................................................................. 4-78

4.6.2.38 - PRODUCT NAME ................................................................................................................................................. 4-78

4.6.2.39 - RECALL NUMBER................................................................................................................................................. 4-78

4.6.2.40 - RECEIPT ISSUED (RECEIPT TYPE)............................................................................................................................. 4-78

4.6.2.41 - RELATED SAMPLES............................................................................................................................................... 4-78

4.6.2.42 - RESP. FIRM TYPE................................................................................................................................................. 4-79

4.6.2.43 - SAMPLE BASIS..................................................................................................................................................... 4-79

4.6.2.44 - SAMPLE CLASS .................................................................................................................................................... 4-79

4.6.2.45 - SAMPLE COST ..................................................................................................................................................... 4-79
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4.6.2.46 - SAMPLE DELIVERED DATE ..................................................................................................................................... 4-79

4.6.2.47 - SAMPLE DELIVERED TO......................................................................................................................................... 4-79

4.6.2.48 - SAMPLE DESCRIPTION .......................................................................................................................................... 4-80

4.6.2.49 - SAMPLE FLAGS.................................................................................................................................................... 4-80

4.6.2.50 - SAMPLE NUMBER................................................................................................................................................ 4-80

4.6.2.51 - SAMPLE ORIGIN .................................................................................................................................................. 4-80

4.6.2.52 - SAMPLE SENT TO................................................................................................................................................. 4-80

4.6.2.53 - SAMPLE TYPE...................................................................................................................................................... 4-80

4.6.2.54 – SAMPLING ORGANIZATION................................................................................................................................... 4-80

4.6.2.55 – STATE ............................................................................................................................................................... 4-80

4.6.2.56 – STATUS ............................................................................................................................................................. 4-80

4.6.2.57 - STORAGE REQUIREMENTS ..................................................................................................................................... 4-81

4.6.2.58 - 702(B) PORTION COLLECTED ................................................................................................................................ 4-81

4.6.2.59 - 704(D) SAMPLE .................................................................................................................................................. 4-81

4.6.3 –LAB SERVICING TABLE (LST) DASHBOARD.......................................................................................................... 4-81

4.6.3.1 – OTHER INFORMATION ........................................................................................................................................... 4-82

4.6.4 – ROUTING .................................................................................................................................................. 4-82

4.7 - SAMPLING: PREPARATION, HANDLING, SHIPPING....................................................................................... 4-82

4.7.1 – OBJECTIVE................................................................................................................................................. 4-82

4.7.2 - IDENTIFYING MARKS..................................................................................................................................... 4-82

4.7.2.1 – SUBSAMPLES........................................................................................................................................................ 4-82

4.7.2.2 - BORROWED SAMPLES ............................................................................................................................................ 4-83

4.7.2.3 - IDENTIFICATION TECHNIQUES .................................................................................................................................. 4-83

4.7.2.4 – PHOTOGRAPHS..................................................................................................................................................... 4-83

4.7.2.5 - RECORDS - ACCOMPANYING LITERATURE AND EXHIBITS ............................................................................................... 4-84

4.7.3 - SAMPLE HANDLING ...................................................................................................................................... 4-84

4.7.3.1 – FUMIGATION ....................................................................................................................................................... 4-84

4.7.3.1.1 - Fumigation Safety Precautions...................................................................................................................... 4-85

4.7.3.1.2 - Procedures For Fumigation ........................................................................................................................... 4-85

4.7.3.1.3 - Exceptions To Fumigation ............................................................................................................................. 4-85

4.7.3.1.4 - Preservation Liquids...................................................................................................................................... 4-85

4.7.3.2 – SAMPLES FOR LABEL AND LABELING REVIEW ............................................................................................................. 4-85

4.7.3.3 - SAMPLES FOR PATHOLOGICAL EXAMINATION ............................................................................................................. 4-86

4.7.3.4 - SMALL SAMPLE ITEMS ............................................................................................................................................ 4-86

4.7.3.5 - FROZEN SAMPLES .................................................................................................................................................. 4-86

4.7.3.5.1 - Shipping Frozen Samples............................................................................................................................... 4-87

4.7.3.5.2 – Control .......................................................................................................................................................... 4-88

4.7.3.6 - REFRIGERATED (NOT FROZEN) SAMPLES ................................................................................................................... 4-88

4.7.3.6.1 – Control .......................................................................................................................................................... 4-88

4.7.4 - OFFICIAL SEALS ........................................................................................................................................... 4-88

4.7.4.1 – PREPARATION OF OFFICIAL SEAL ............................................................................................................................. 4-89

4.7.4.2 – APPLICATION ....................................................................................................................................................... 4-89

4.7.4.3 - SEALING METHOD ................................................................................................................................................. 4-89

4.7.4.4 - PROTECTING THE OFFICIAL SEAL............................................................................................................................... 4-89

4.7.4.5 - BROKEN OFFICIAL SEALS ......................................................................................................................................... 4-90

4.7.4.6 - METAL SEALS........................................................................................................................................................ 4-90

4.7.4.7 - SEALING NON-SAMPLE ITEMS.................................................................................................................................. 4-90

4.7.5 - SAMPLE SHIPMENT....................................................................................................................................... 4-90

4.7.5.1 PREPARING THE BOX FOR SHIPPING............................................................................................................................. 4-90

4.7.5.2 - METHOD OF SHIPMENT .......................................................................................................................................... 4-91

4.7.5.2.1 - USPS Shipments............................................................................................................................................. 4-91
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4.7.5.2.2 – Contract Carrier Shipments.......................................................................................................................... 4-91

4.7.5.2.3 – Use of other Shippers for Samples............................................................................................................... 4-91

4.7.5.3 - FDA 525 - SAMPLE PACKAGE IDENTIFICATION........................................................................................................... 4-91

4.7.5.4 - ROUTING OF SAMPLES............................................................................................................................................ 4-92

4.7.5.4.1 - Samples to Administration Laboratories....................................................................................................... 4-92

4.7.5.4.1.1 - Split Samples............................................................................................................................................... 4-92

4.7.5.4.2 - Sample Shipment to Outside Agencies.......................................................................................................... 4-92

4.7.5.5- NOTIFYING RECEIVING LABORATORIES ....................................................................................................................... 4-92

4.7.5.6 - SHIPMENT OF HAZARDOUS OR TOXIC ITEMS............................................................................................................... 4-93

4.7.5.7 – ADDITIONAL PRECAUTIONS WHEN SHIPPING SAMPLES ............................................................................................... 4-93

4-1- FACTS SAMPLE COLLECTION SCREEN............................................................................................................ 4-94

4-2 FACTS SAMPLE COLLECTION SCREEN............................................................................................................. 4-98

4-3 AFFIDAVIT (IN-TRANSIT)- FDA 1664B ............................................................................................................ 4-99

4-4 CARRIER’S RECEIPT FOR SAMPLE – FDA 472 ................................................................................................. 4-100

4-5 – INSTRUCTIONS FOR COMPLETEING THE FDA 484, RECEIPT FOR SAMPLES................................................... 4-101

4-6 – FIELD WEIGHT SHEET – FDA 485................................................................................................................ 4-104

4-7 – AFFIDAVIT – “301(K) SAMPLE” – FDA 463A................................................................................................ 4-105

4-8 – COPY OF INVOICE/SHIPPING RECORD – FD 1662........................................................................................ 4-106

4-9 AFFIDAVIT (PARCEL POST) – FDA 463A......................................................................................................... 4-107

4-10 - AFFIDAVIT – FDA 463A............................................................................................................................ 4-108

4-11 – AFFADAVIT – FDA 463A........................................................................................................................... 4-109

4-12 – AFFIDAVIT – (DEALER/WAREHOUSEMAN) – FDA 1664 ............................................................................. 4-110

4-13 – AFFIDAVIT – FDA 463A............................................................................................................................ 4-111

4-14 – AFFIDAVIT – (JOBBER) – FDA 1664A ........................................................................................................ 4-112

4-15 FACTS SAMPLE COLLECTION SCREEN.......................................................................................................... 4-113

4-16 FACTS SAMPLE COLLECTION SCREEN.......................................................................................................... 4-114

4-17 OFFICAL SEAL – FDA 415A.......................................................................................................................... 4-116

4-18 DECLARATION FOR DANGEROUS GOODS ................................................................................................... 4-117

4-19 DRY ICE LABEL ........................................................................................................................................... 4-118

4-20 ENVIRONMENTAL SAMPLING FOR DETECTION OF LISTERIA MONOCYTOGENES, CFSAN GUIDANCE.............. 4-119

4-21 ENVIRONMENTAL SAMPLING FOR DETECTION OF SALMONELLAE, CFSAN GUIDANCE.................................. 4-120

1- SALMONELLA SAMPLING PLAN...................................................................................................................... 4-122

2- SAMPLING SCHEDULE FOR LOW-ACID CANNED AND ACIDIFIED FOODS .......................................................... 4-126

3- PESTICIDE SAMPLES .........................................................................................................................................130

4- WHEAT CARLOAD SAMPLING ........................................................................................................................ 4-137

5- IMPORTED WHITEFISH SAMPLING SCHEDULE ................................................................................................ 4-139

6- MYCOTOXIN SAMPLE SIZES ........................................................................................................................... 4-142

7- SAMPLING SCHEDULE FOR CANNED FRUIT - FILL OF CONTAINER - AUTHENTIC PACK..........................................143

8- SAMPLING SCHEDULE FOR IMPORTS - COFFEE, DATES AND DATE MATERIAL .....................................................144

9- SAMPLING SCHEDULE FOR COLOR CONTAINING PRODUCTS & COLOR ADDITIVES........................................... 4-145

10- DRUG SAMPLING SCHEDULES.........................................................................................................................147

11- VETERINARY PRODUCTS, FEEDS, & BY- PRODUCTS FOR ANIMAL FEEDS ........................................................ 4-148

12- MEDICATED ANIMAL FEEDS SAMPLING........................................................................................................ 4-149

13- SAMPLE SIZES WITH APPLICATION TO FOOD PRODUCTS FOR ALLERGENS ..................................................... 4-150

4-22 SAMPLE CRITERIA FOR SELECTIVE SAMPLING FOR FILTH............................................................................. 4-151

GENERAL GUIDANCE FOR SELECTIVE SAMPLING...................................................................................................................... 4-151

DOCUMENTING RODENT CONTAMINATION ........................................................................................................................... 4-152

EXAMINATION AND DOCUMENTATION OF RODENT CONTAMINATION ........................................................................................ 4-153

COLLECTING EXHIBITS OR SUBSAMPLES FO RODENT CONTAMINATION........................................................................................ 4-154

SUMMARY OF SAMPLE FOR RODENT EVIDENCE ...................................................................................................................... 4-155

DOCUMENTING INSECT CONTAMINATION.............................................................................................................................. 4-155
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EXAMINATION AND DOCUMENTATION OF INSECT CONTAMINATION........................................................................................... 4-156

COLLECTING EXHIBITS OR SUBSAMPLES OF INSECT CONTAMINATION.......................................................................................... 4-156

SUMMARY OF SAMPLE FOR INSECT EVIDENCE......................................................................................................................... 4-156

DOCUMENTING BIRD/AVIAN CONTAMINATION...................................................................................................................... 4-156

EXAMINATION AND DOCUMENTATION OF BIRD CONTAMINATION ............................................................................................. 4-157

COLLECTING EXHIBITS AND SUBSAMPLES ............................................................................................................................... 4-157

SUMMARY OF SAMPLE FOR BIRD EVIDENCE ........................................................................................................................... 4-157

DOCUMENTING CHEMICAL CONTAMINATION......................................................................................................................... 4-158

DOCUMENTING MOLD CONTAMINATION .............................................................................................................................. 4-158

4-23 – AFFIDAVIT – FDA 463A............................................................................................................................ 4-160

4-24 – HQ LABS................................................................................................................................................. 4-163

4-25 C/R DATA ELEMENTS IN ORDER OF ENTRY INTO FACTS............................................................................. 4-168
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4.1 – General 

Collecting samples and conducting inspections (both of which are discussed in Chapter 5) and reviewing imported

products at entry (which is discussed in Chapter 6) are the primary ways investigators contribute to ORA’s mission of 

protecting consumers and enhancing public health by maximizing compliance of FDA-regulated products and 

minimizing risks associated with those products. 

This chapter will provide further information to support you in those tasks, mainly to assist you in collecting, 

documenting, and submitting samples for analysis and/or review. While this chapter details the process of collecting 

samples for many of the situations you are likely to encounter, it is important to note that each sample collection is 

unique. If you should encounter situations not covered in this chapter and need additional information, consult with 

your supervisor and, if needed, the relevant servicing laboratory.

4.1.1 – Purpose – Why Do We Collect Samples? 

Collecting samples is a critical part of FDA's regulatory activities. We collect samples of FDA-regulated products for a 

variety of reasons, such as: 

1. to gather information about potential safety issues (i.e., surveillance). 

2. to document a violation. 

3. to support the government’s charge that there is a violation of the law. 

This chapter contains information on the following topics: 

1. the types of samples investigators collect, 

2. roles and responsibilities of investigators when collecting samples, 

3. procedures for collecting and reporting of samples, and

4. examples of special sampling situations. 

4.1.1.1 – What is a valid sample? 

A valid sample is the starting point--and keystone--for most regulatory actions. Evidence, as you know, is required 

to support your observations and reports of violative conditions—and samples of FDA-regulated products can be 

used as evidence. However, to be used as evidence, the sample must support the government's charge that there 

is a violation of the law. It must also conform to the rules on admissibility of evidence, such as demonstrable chain 

of custody. 

In general, a properly collected and prepared sample (in other words, a valid sample) contains or is accompanied 

by the following:

1. A portion of the lot 1 of goods for laboratory analysis and a 702(b) 2 reserve portion of the goods, if appropriate, 

and/or documentation demonstrating the violation represented by the lot. 

2. A report of your observations of the lot. 

1 A lot generally means a specific quantity of a finished product or other material that is intended to have uniform character and 

quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

2 Section 702(b) of the FD&C Act [21 USC 372(b)] requires the FDA to furnish, upon request, a portion of an official sample for 

examination or analysis to any person named on the label of an article, the owner thereof, or his attorney or agent.
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3. Labels and labeling, or copies of such, which "accompany" the goods.

4. Documentary evidence of federal jurisdiction over the lot, including where the violation was committed;

information about individuals responsible for the violation; and similar information. 

5. Signed statement (affidavit) from individuals who may be called upon as witnesses should there be a 

subsequent court action.

While inspections and investigations may precede sample collection, under the law, a valid sample must ultimately 

be obtained for judicial cases to proceed. 

4.1.1.2 – What are your responsibilities when collecting a valid sample? 

Proper sample collection is the keystone of effective enforcement action. Approach every sample you collect with

diligence and thoroughness, and the mindset that you may be asked to testify in court regarding all details 

associated with the sample, including the actions you took while collecting it. Take regulatory notes regarding your 

sample collection that will provide sufficient detail to refresh your memory at a later date (see IOM 2.1 for 

additional information on regulatory notes). Be objective, factual, accurate, and thorough. Mistakes or 

deficiencies, however trivial they may seem, can damage the government's case.

Sample numbers are obtained using the FDA sample reporting systems. For samples that are not in import status, 

you are responsible for obtaining sample numbers in the Field Accomplishments and Compliance Tracking System 

(FACTS) in advance of collecting a sample and completing the Collection Report (C/R) in FACTS. For samples 

collected while products are in import status, sample numbers are obtained when Import C/Rs are completed in 

FDA Import Systems (OASIS/SERIO).

You are responsible for timely completion of the Collection Report after collecting the sample (See IOM 4.6.2 for 

minimum information to be entered into FACTS).

4.1.1.3 – Personal Safety while Collecting Samples 

It is important to note that, while sampling, you may encounter situations that could have safety

and personal protective equipment (PPE) considerations. Hazards and/or dangers associated with 

sampling could include, but are not limited to:

1. Dusts

2. Explosion hazards

3. Confined spaces

4. Farms and poultry houses

5. Altered atmospheres and environments

6. Biological hazards (e.g., Hantavirus, BSE, parasites, fungus)

7. Chemical hazards

8. Physical and radiation hazards

9. Ergonomic hazards

The IOM Safety Chapter (IOM Chapter S) contains basic information to help you anticipate, recognize, evaluate, 

and apply control strategies to eliminate or minimize hazardous conditions and unsafe practices you may 

encounter.

Due to the variability of potential safety situations during sampling, it is not feasible to describe what to do in each 

instance. The decision of what to do in each individual circumstance rests with you, your Industrial Hygienist

liaison, and your program division management.

When you are unsure about the best and safest way to collect a sample, talk to your supervisor.
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4.1.2 – Authority to Collect Samples 

IOM section 2.2.2 outlines FDA’s authority to collect samples and provides references to relevant sections of the Food 

Drug and Cosmetic Act (FD&C Act). Understanding the statutory authority can assist you in your daily work, including 

when faced with a refusal to permit a sample collection, for example. You can find detailed information about the 

statutory and regulatory frameworks underpinning our FDA sampling authority in chapter 2 of the IOM.

Section 801 of the FD&C Act [21 U.S.C. 381] gives the FDA the authority to collect samples of FDA-regulated products 

which are being imported or offered for import into the United States (see IOM 6.1 for more information on FDA’s 

import operations and import authority).

4.1.3 – Responsible Parties 

There are many types of individuals that can be responsible for assuring FDA-regulated products are neither 

adulterated nor misbranded. You should be familiar with the following definitions. It is important to properly identify 

these parties when you collect a sample so that the appropriate action can be taken if a sample is violative.

4.1.3.1 – Dealer 

Dealer means the person3 who has possession of the FDA-regulated product at the time the sample is collected. 

Note that the dealer may not necessarily be the owner of the goods, but the one in possession of them at time of 

sample collection, such as a third-party logistics company. In addition, the dealer may or may not be the party 

responsible for the violation (i.e., responsible party). 

For example, in the case of a “301(k) sample,” the responsible party will always be the dealer. Under Section 

301(k) of the FD&C Act [21 U.S.C. 331(k)] it is prohibited to alter, mutilate, destroy, obliterate, or remove the 

whole or any part of the labeling of, or the do any other act with respect to FDA-regulated products, if such act is 

done while held for sale (whether or not the first sale) after shipments in interstate commerce and results in such 

article being adulterated or misbranded. IOM 4.1.4.2.2 provides additional information on 301(k) samples.

If the person you are collecting samples from may be subject to FDA regulatory action, given a likely or known 

violative condition of a lot, you should issue them a Form FDA 482 before collecting samples. See IOM 4.1.2. If in 

doubt about the need to issue a Form FDA 482, it's better to err on the side of caution and proceed with issuing 

the form. If there is no EIR, attach a copy of the FDA 482 to the collection report (C/R). See IOM 4.6.4

4.1.3.2 – Manufacturer 

Manufacturer means the person that makes the FDA-regulated product. If you collect a sample from the 

manufacturer, then the dealer and manufacturer are the same. 

Determining if the manufacturer is the party responsible for the violation will depend on several factors and, in 

most situations, will require further investigation. For example, if you collect a sample of animal food at a farm

where a customer experienced death of their animals and that sample is confirmed to be adulterated, then an 

investigation to determine where, and at what stage, the adulteration occurred should be conducted. If the 

adulteration is determined to be caused by the animal food manufacturer, then the manufacturer committed a 

prohibited act as the introduction or delivery for introduction into interstate commerce of any food that is 

adulterated or misbranded is prohibited under Section 301(a) of the FD&C Act [21 U.S.C. 331(a)]. 

3 Section 201(e) of the FD&C Act [21 U.S.C. 321(e)] defines the term person as an individual, partnership, corporation, or 

association. Throughout this chapter this definition is used.
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4.1.3.3 – Shipper 

Shipper means a person (e.g., the manufacturer or a freight broker) who arranges for the transportation of food or 

other commodity in the United States by a carrier or multiple carriers sequentially.

4.1.3.4 – Carrier 

Carrier means a person (e.g., owner-operator, partnership, corporation) who physically moves a product by rail or 

motor vehicle in commerce within the United States. The term carrier does not include any person who is 

transporting product while operating as a parcel delivery service.

4.1.4 – Official Samples 

Title 21, Code of Federal Regulations, Part 2.10 (21 CFR 2.10) describes the criteria required for a sample of FDAregulated product to be considered an official sample. A sample is an official sample if records (see IOM 4.4.4) or other 

evidence obtained show that the shipment, or other lot of the article from which the sample was collected, was: 

1. Introduced or delivered for introduction in interstate commerce, or

2. Was in or was received in interstate commerce, or

3. Was manufactured in a Territory or the District of Columbia.

Section 201(a)(2) of the FD&C Act [21 U.S.C. 321 (a)(1)] defines the term Territory as any Territory or possession of the 

United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone.

A sample of a device, tobacco product, counterfeit drug, or any object associated with drug counterfeiting, no matter 

where it is collected, is also an official sample. Section 304(a)(2) of the FD&C Act [21 U.S.C. 334(a)(2)] permits 

proceeding against these articles, when violative, at any time.

Import samples are official samples and require you handle them with the same care and diligence as domestic official

samples (see IOM 6.5). 

Official samples can be either physical or documentary (the latter referred to as DOC samples). The only difference 

between a physical official sample and a DOC official sample is that the physical article is not collected for a DOC 

sample since DOC samples consist only of records. Both physical and DOC samples are official samples if they meet the 

description in 21 CFR 2.10. Details about collecting these samples are provided in IOM 4.1.4.2, for physical samples, 

and 4.1.4.1, for DOC samples. 

Every sample collection is unique. Whether you are collecting a physical sample or a DOC sample, one thing that 

remains consistent is that both types of official samples (i.e., physical and DOC) need to be representative of a lot for 

which federal jurisdiction can be established. If violative, the official sample will serve as a basis for enforcement 

action. 

The FDA has various enforcement tools that can generally be divided into the following categories: advisory actions

and other notices of violations; administrative actions; and judicial actions (see IOM Chapter 2 for more information 

about FDA’s regulatory tools). While a valid sample is typically the starting point, and keystone, for most regulatory 

actions, there are different requirements for collection of an official sample, depending on the FDA’s intended

enforcement action. Advisory actions (IOM 2.4) and administrative actions (IOM 2.5), which do not involve the judicial 

system, do not require the collection of an official sample (physical or DOC). However, the requirements to collect 

official samples may vary depending on your assignment, program, and/or division. If you are recommending an 

advisory action, consult with your supervisor to determine if an official sample is required. DOC samples, which include

the collection of records demonstrating interstate commerce, are required for judicial actions, such as seizure and 

injunction. 
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For the FDA to initiate a legal action, interstate jurisdiction must be established. Most often, this is done by 

documenting interstate movement of a product by copying records ("getting the records") of a shipment represented 

by an official sample. There are products and situations where interstate commerce is not required to act against a 

violative product (for example, in cases involving counterfeit drugs, medical devices, oleomargarine/colored 

margarine, or products manufactured in a territory of the United States). If you encounter these situations, discuss the 

need for collecting interstate commerce records with your supervisor, or follow established procedures within your 

division or program regarding the collection of interstate commerce records. 

The type of interstate records (transportation records, freight bill, waybill, bills of lading. etc.) to be collected are 

outlined in IOM 4.4.4. Note that the evidence required to demonstrate interstate commerce, and the types of records 

needed to establish it, depends upon the violation and the type of judicial action proposed.

To meet the criteria of a valid sample, the official sample must meet all of the following conditions: 

Accompanied by records that establish both the federal jurisdiction and the identity of the individual(s) having 

knowledge of the lot's movement and custody of its records [see IOM 4.4.4]. (Evidence of interstate

movement is not required for medical device samples but, according to policy, is to be obtained when a 

seizure, injunction, prosecution, or civil penalty is contemplated).

Representative of the lot from which it was collected.

If a physical sample, large enough to permit proper laboratory examination and provide a 702(b) reserve portion 

when necessary. (See IOM 4.3.2.2 for more information on collecting 702(b) portion.) 

Handled, identified, and sealed in such a manner as to maintain its integrity as evidence, with a clear record of its 

chain of custody.

Every official sample (physical or DOC) will be fully documented at the time of collection (that is, recorded in your 

regulatory notes) and a collection report prepared, unless instructed otherwise by the program or assignment. 

4.1.4.1 – Documentary Samples (DOC Samples) 

4.1.4.1.1 – What is a documentary official sample (DOC sample)? 

A DOC sample is not a sample of records. It is a sample representing a lot of a regulated article (e.g., food, 

drug, biologic, or device). Other elements of an official sample described in IOM 4.1.4 are required and apply 

except DOC samples are not officially sealed. DOC samples consist of the article's labels (photocopies or 

photos), accompanying labeling (e.g., leaflets, brochures, promotional materials, including internet websites) 

and documentation of interstate movement (e.g., freight bills, bills of lading, affidavits; see IOM 4.4.4). Refer 

to Section 201 of the FD&C Act [21 U.S.C. 321] for the definition of labels (201(k)) and labeling (201(m)). 

Typically, your DOC sample would also include additional documents (i.e., supporting evidence), such as 

photos of the product, drawings, sketches or schematics, production records, diagrams, invoices, or similar 

items. (See IOM Exhibits 4-1 and 4-2.) These additional records typically demonstrate the violation you are 

documenting. For example, production records for a specific lot may show a violation of GxPs 4

. A physical 

sample is not required, because under GxPs FDA does not need to show the product fails to meet a 

specification. Failure to meet GxPs renders the product adulterated. In the cases of misbranding, the labels or 

labeling may be all that is required to demonstrate the violation.

Because no product is collected, a Form FDA 484, Receipt for Samples, is not issued for DOC samples. 

4 GxP is a term which includes all practices related to manufacturing FDA products, e.g., good manufacturing practices, 

good clinical practices, good laboratory practices, etc.
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See IOM 4.7.2.5 and speak to your supervisor about any division or program specific guidance on identifying 

records associated with a DOC sample. Do not officially seal these records. List all records on the collection

report (C/R). Use a continuation sheet (FDA 464a) if necessary. If any photos are taken as part of the DOC 

sample, the electronic media must be officially sealed per IOM 5.3.4.2 or IOM 5.3.4.3. Attach the documents

and photos along with any other records associated with the sample to the printed C/R. See IOM 4.6.4.

When the anticipated action is not judicial, records of interstate commerce and documentation of violations 

may be collected and added to the EIR in lieu of a DOC sample. If you are unsure if you should collect a DOC 

sample or document interstate commerce in your EIR, consult your supervisor. 

4.1.4.1.2 - When Should You Collect a DOC Sample instead of an Actual Physical Sample of the Product? 

A DOC sample is collected when an actual physical sample is not practical. For example, in instances in which 

the article is:

1. very large or complex, 

2. fixed, as in the case of a permanently installed device, 

3. too expensive/cost prohibitive to sample, 

4. no longer available, 

5. there is no need for laboratory examination, 

6. must remain in place due to on-site emergency purposes, like a single piece of life support 

equipment which must remain in emergency service until a replacement is available.

7. going to be recommended for seizure based on misbranding charges. For instance, if during 

availability check, the lot sampled is found to have been distributed, but a new shipment, identically 

labeled, is on hand, then the new shipment may be sampled on a DOC basis since another physical 

sample and examination is not required. In this case, regulatory action may proceed based on the 

earlier examination, and thus, only labeling, transportation records, the appropriate dealer 

affidavits, and an inventory of product on hand need to be obtained.

A variation of this procedure involves collecting one or more units and removing (stripping) the original 

labels/labeling from the product container. It is frequently easier and quicker to collect relatively inexpensive 

units for field stripping than it is to photocopy or photograph all accompanying labels. In these cases, the 

sample is handled in the same manner as any other DOC sample, once the original labeling has been removed 

and the remainder of the sample destroyed. You will want to provide a prominent explanation on the 

collection report to alert reviewers that the original units collected were destroyed after the original labeling 

was removed. Note, however, that this field-stripping procedure is not appropriate in instances in which 

complete, intact, and labeled units are desired for exhibit purposes, even though there is no intention of 

analyzing the units obtained.

A DOC sample collected to document deviations of GxPs should contain records that adequately document the 

deviations encountered. You should explain what is being documented in the remarks section of the C/R of the 

documents obtained. Fully describe any record collected as part of the DOC sample, and wherever possible, 

indicate the page of the document that demonstrates the deviation.

Documentary (DOC) samples are not required to support advisory actions such as untitled or warning letters

and regulatory meetings. However, records of interstate commerce should always be collected and 

incorporated into the establishment inspection report (EIR) to document FDA jurisdiction over any products 

suspected to be in violation. An affidavit (see IOM 4.4.5) identifying the product(s) of concern, labels/labeling, 

invoices, statements regarding interstate commerce, and key evidence of violations should be prepared for 
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signature by the appropriate party and attached to the EIR in support of advisory actions. DOC samples should 

always be prepared in situations in which further FDA judicial and/or administrative action is anticipated such 

as seizure, injunction, warrants, administrative detention, suspension of registration, mandatory recall and 

prosecutions. Investigators in training may still be required to prepare documentary samples as directed by 

their supervisor. 

4.1.4.2 – Physical Samples 

Refer to IOM 4.1.4.2.1 – 4.1.4.2.11 for some examples of situations warranting collection of physical official 

samples and how you should proceed in collecting them.

4.1.4.2.1 – In-transit sample

In-transit samples are those collected from lots being transported in vehicles or held on loading/receiving 

docks of steamships, truck lines, or other common carriers. A lot is considered to be in-transit if it meets any of 

the following characteristics:

1. A bill of lading (BOL) or other order to ship the lot interstate has been issued; or 

2. The owner/shipper or agent acknowledges, preferably by signed affidavit, that they ordered the lot to 

be shipped interstate; or

3. The owner or operator of the common carrier acknowledges, preferably by signed affidavit, that they

have an order from the shipper to move the lot interstate. 

Refer to IOM 4.2.4, 4.2.5.1, and 4.3.3 for special considerations when collecting an in-transit sample. 

4.1.4.2.2 – 301(k) sample 

A 301(k) sample is typically defined as a sample collected from a lot of food, drugs, devices, tobacco products, 

or cosmetics that has become adulterated or misbranded while being held for sale, regardless of whether or 

not its first sale, after shipment in interstate commerce. See Section 301(k) of the FD&C Act [21 U.S.C. 331(k)]

for complete language surrounding this prohibited act. The term 301(k) sample is shorthand to describe 

certain samples collected from lots that become violative after shipment in interstate commerce.

Since some act took place that resulted in the adulteration or misbranding of a previously non-violative 

product after shipment in interstate commerce, it is necessary in any 301(k) documentation that you: 

1. Identify the act causing or leading to the adulteration or misbranding, 

2. Establish when and how this act occurred, and 

3. Identify the individual(s) responsible for causing the violation. 

This last feature, more than any other, distinguishes a 301(k) sample from other physical official sample types. 

When you report the sample collection, the responsible party will always be the dealer. See IOM Exhibits 4-1 

and 4-7. 

Consider the following example of a 301(k) sample and steps taken to establish it: To document Listeria 

monocytogenes adulteration, for instance, of a ready-to-eat food caused by contamination of a raw material at 

the finished product manufacturer, you would need to document receipt of an unadulterated, raw material as 

well as the subsequent adulteration caused by the firm’s handling or processing of the raw material during the 

manufacturing of the ready-to-eat food. As such, you would need to show that there was L. monocytogenes at 

the manufacturer that either did, or may have, contaminated the ready-to-eat finished product. To establish a 

violation of 301(k), you would also need to demonstrate that the raw material was not adulterated prior to 

receipt at the manufacturer. Towards this end, you would collect an official sample of the unadulterated raw 

material. (You would also typically collect an investigational sample consisting of environmental swabs from 
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the processing areas and/or equipment for analysis of L. monocytogenes to attempt to determine the location 

in which the unadulterated, raw material was contaminated.) The interstate commerce is demonstrated for 

the sample, not through the product manufactured at the location, but the incoming product that was not 

adulterated.

301(k) samples can also be used to document adulteration (including noncompliance with GxPs) or 

misbranding of other regulated commodities, including medical devices, drugs, and biologics. Note the 

following guidance associated with 301(k) samples and various commodities. For example, when collecting a 

301(k) sample associated with a drug product, you should attempt to document 'adulteration' or 'misbranding' 

of the active ingredient by the firm's actions. There may be cases where the active ingredient was not received 

in interstate commerce. In these instances, you would instead document the container or another ingredient 

that was received in interstate commerce. In cases involving biologics, for example, a DOC sample may be 

collected of a container or bag used for collection of whole blood, because the product (whole blood) was 

collected at the donor site being inspected. Since the whole blood is collected onsite, there is no interstate 

commerce for it. However, the firm subsequently may have adulterated or misbranded the anti-coagulant (a 

drug) in the blood bag.

And when collecting a 301(k) sample for medical devices from a finished device manufacturer, you should

collect and document all of the following:

1. Interstate shipment records for receipt of a component.

2. The manufacturing records showing inclusion of the component in the finished device.

3. Records showing the finished device was held for sale or distributed, regardless of whether or not in 

interstate commerce.

4. Labels, labeling for the finished device.

Your observations and documentation should demonstrate the firm’s actions adulterating (e.g., GMP issues) or 

misbranding (e.g., labeling) the finished device that was distributed in relation to the associated component. 

4.1.4.2.3 – Post-Seizure (PS) sample 

A lot under seizure is in the custody of the U.S. Marshals Service. If either the claimant or the government 

desires a sample from the seized lot, it may be collected only by court order. In most cases, the order will 

specify how the sample is to be collected and may provide for each party to collect samples. If the order was 

obtained by the claimant, permit the claimant's representative to determine how to collect the sample. If the 

method of collection is improper, you may make constructive suggestions, but do not but do not challenge or 

interfere with the method that is chosen. You should, however, report exactly how the sample was drawn. 

Unless the claimant objects, mark subsamples collected with the notation, “PS", your initials, and the date. PS

samples are official samples. Do not pay for post-seizure samples, or any samples collected of a lot 

reconditioned under a Consent Decree. See IOM 4.2.8.1.

4.1.4.2.4 – Import sample

Import samples are physical samples of products that originate from another country, collected while the 

goods are in import status. Import status ends when U.S. Customs and Border Protection (CBP) releases the 

article from the import database system. (See IOM Chapter 6.)

4.1.4.2.4.1 – Special Domestic Import Sample (SDI) 

SDIs are import samples collected from lines that are released from import status immediately after 

collection and before sample analysis is complete. This sample type is used primarily for the collection of 

perishable products and special sampling assignments. This sample type may also be used for other 

designated sampling situations as directed. (See IOM chapter 6.5.7.)
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4.1.4.2.4.2 – Mail Entry sample 

A mail entry sample is a sample of an imported product that enters the United States through the U.S. 

Mail. 

4.1.4.2.5 – Domestic import sample (DI) 

DI samples are official samples of foreign products that have passed through customs and are now in domestic 

commerce. The FDA may have previously taken a sample of the product while in import status, or the product 

may have been permitted entry without being sampled. If sampled while still in import status, the samples 

collected are import samples, and not DI samples. However, once the product leaves import status and enters 

domestic commerce, any sample collected from it is then considered an official DI sample. 

When collecting DI samples, especially if a violation is suspected, attempt to determine the port of entry and 

the importer of record (the party in whose name the entry is made, see IOM 6.7.21). Report this information 

on the C/R, where you should include the name of the country of origin of the product and the country code, if 

known.

A sample is classified as DI, if any of the following situations apply:

1. The label declares the product to be from a foreign country,

2. The label bears the word, imported,

3. Records obtained or reviewed reveal the product originated in a foreign country,

4. It is known that the product is not grown or produced in the United States; is packed as a single item 

with few, or no other ingredients added; and is not manipulated in any major manner that would 

otherwise change the product or its composition. For example, olive oil imported in bulk and merely 

repacked with no added ingredients and no manipulation would be a DI sample; while pepper, which is 

processed, ground, and packed after entry would not. However, retail packages of ground pepper 

processed and packaged in a foreign country would be DI samples

5. Samples of imported raw materials, which are collected before further processing or mixed with other 

ingredients.

6. DI samples are significantly different from other official samples in another important respect. Unlike 

domestic products, for which considerable information is readily available on manufacturing and 

distribution channels, it is frequently difficult to identify the responsible parties for products of foreign

origin once they enter domestic commerce. The most practical way to achieve this is to establish a 

paper trail of records going back as far as possible in the distribution chain to the actual entry.

7. Preface the sample number with the prefix “DI” in the same manner that other sample type prefixes 

are used (e.g., "DOC", “INV”, "PS") on:

• The physical product (sample), 

• Related documents

• Official Seals

4.1.4.2.6 – Additional Sample 

This is a physical sample collected from a previously sampled lot of either a domestic or imported product.

Note the following sample numbering approaches:
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1. In instances of additional import samples, the sample collected must have the same sample number as 

the original sample collected. 

2. In instances of additional domestic samples, the sample collected will have a different sample number, 

but it must be flagged as an Additional sample and the original sample number referenced in the Related 

Sample block on the C/R.

4.1.4.2.7 – Reconditioning sample 

Reconditioning samples are taken from lots that have been reconditioned under a consent decree, or other 

agreement, to bring the lots into compliance with the law. The sample is taken to determine if the 

reconditioning was satisfactorily performed. These samples should be submitted as official samples.

4.1.4.2.8 – Audit/Certification sample 

A sample collected to verify analytical results provided by a certificate of analysis or private laboratory analysis 

that purports to show a product complies with the FD&C Act and/or regulations. This sample type is typically

used with import samples. See IOM 4.1.4.2.4. 

The ORA Lab Manual, Volume 3, Section 7 provides specific guidance on FDA audit samples. FDA audit samples 

provide an opportunity for investigators to examine privately sampled, regulated commodities for 

conformance with an associated, submitted private lab package. Prior to collecting the FDA audit sample, you 

should carefully examine the associated lot for comparison to the private lab package evidence (i.e., 

photographs and documentation). Examples of items to note during such examination and comparison to the 

private lab's packet include:

1. Evidence of marked containers distributed throughout the lot, indicative of a representative sample. 

2. Marked cases that are consistent with the submitted lab package.

3. Quantity removed for sampling is consistent with the lab package.

Careful attention should also be paid to any indication that the containers selected for sampling by the private 

sample collector have been staged for sampling. Staging is relected through markings, deliberate damage to 

labeling, and placement within the pallets, for example.

If you find evidence that a non-conforming private sample was collected, it is important that you immediately 

terminate audit activities/sampling and report the adverse findings to appropriate compliance staff for 

evaluation. The agency will then make decisions on a lot-by-lot, case-by-case basis regarding the entries and/or

sampled products submitted for importation.

Note, too, that audit samples should be recorded under the same PAC codes as surveillance samples and can 

apply towards the completion of applicable work plan and/or performance goals.

4.1.4.2.9 – Induced Samples 

An induced sample is an official sampled ordered or obtained in response to some type of advertisement or 

promotional activity. The sample is procured by mail, telephone, online order, or other means, without 

disclosing any association of the requester or the transaction to the FDA. See IOM 4.3.4.2 for additional 

information.

4.1.4.2.10 – Undercover Samples (Commonly Known As Undercover Buys) 

An undercover sample (or undercover buy) is an official sample, obtained in much the same manner as an 

induced sample. Undercover buys may be made at the point of sale, or via a purchase completed online, by 

email, text, or by phone. Explanations and/or cover stories, developed ahead of time, are necessary to dispel 

any suspicions about the requester that may surface in face-to-face, phone, or email discussions. Undercover 
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buys are frequently used in investigations of health fraud or complaints of illegal activity, in which the 

information cannot be substantiated or refuted through more conventional means.

Undercover buys may be used to augment an existing investigation or inspection effort and may be performed 

to document violations in firms with a history or pattern of noncompliance. See IOM 4.3.4.2 for additional 

information on how to collect induced samples, a type of undercover buy. Your supervisor or the assignment 

will provide specific instructions and procedures to be followed when collecting an undercover sample. For 

example, you may induce the sample by telephone or online. You may need a “cover story” if collecting 

multiple containers of the product. If collecting an undercover sample as part of a special assignment, you will 

rely on instructions provided in the assignment. Note, too, that your division or program may also have specific 

procedures to follow when conducting an undercover buy.

4.1.4.2.11 – Online Samples 

An online sample is an official sample purchased online, versus being collected at a physical location. Samples 

may be collected online as induced or undercover buys, but in both cases, the FDA should not be identified as 

the purchaser of the product. Routine samples may also be purchased online as directed by your supervisor or 

by assignment. 

Interstate commerce is still documented for these samples. Interstate commerce evidence can be obtained by 

documenting the location from which the sample is shipped and the method of its delivery (e.g., UPS, USPS, or 

FedEx). These online samples may be collected and paid for using dedicated and unidentifiable equipment (i.e., 

FDA laptop, FDA cell phone, and FDA credit card). Your supervisor and/or the specific assignment will provide 

instructions and procedures to be followed when collecting an online sample. See IOM 4.1.4.2.9, 4.1.4.2.10, 

and 4.3.4.2 for additional information.

4.1.5 – Investigational Samples (INV) 

Investigational (INV) samples are not official samples. They are collected to document observations, support regulatory 

actions, and/or provide other information. As such, they do need to be collected from lots in interstate commerce or 

under federal jurisdiction. The sample itself does not need to be from a product regulated by the FDA. Because these 

samples can be used as evidence in court, they must be sealed, and their integrity and chain of custody protected. 

Examples of INV samples include:

1. Samples flagged as factory food samples or in-line samples. These samples may consist of raw materials, inprocess, and unpackaged finished products that demonstrate manufacturing conditions. See IOM 4.3.6.6.3.

2. Samples associated with exhibits. These may be filth exhibits and other articles taken for exhibit purposes 

during inspections to demonstrate manufacturing conditions, storage conditions, employee practices, or other 

conditions. Typically, filth exhibits submitted as part of an INV sample are not tied to any specific lot of product

but are meant to illustrate the conditions at a firm. For example, samples flagged as INV Samples of filth 

exhibits frequently consist of apparent rodent excreta pellets, apparent nesting material, apparent rodentgnawed material, and other evidence of rodent activity. Multiple sub-samples collected along the entire 

perimeter of a room in a manufacturing facility, food storage area, or warehouse may be used to demonstrate 

a rodent infestation. See IOM 4.6.2.7.7.

3. Environmental samples – See IOM 4.3.6.6.1.

4. Certain complaint samples: These are injury and illness investigation samples from certain complaints in which

there is no federal jurisdiction, or the alleged violation offers no basis for subsequent regulatory action. 
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Contrastly, complaint samples from lots for which federal jurisdiction is clear should be submitted as official 

samples. See IOM 4.1.7

When identifying the sample/subsamples and documents related to the sample, and filling out seals, preface the 

sample number with "INV" in the same manner as other sample prefix types are used (e.g., "DOC", "DI").

Note: Photographs taken to document conditions observed, or subsamples collected, are included as exhibits to 

establishment inspection reports. Photographs taken of labeling and records (e.g., bill of lading (BOL), invoice, and 

manufacturing records) that are associated with sample collections are included as attachments to collection reports. 

See IOM 4.7.2.4, 5.3.3, and 5.3.4. 

4.1.6 – Survey Samples 

Survey samples are part of the FDA’s proactive sampling, conducted on a surveillance basis to gather data or other 

information on FDA-regulated products. Survey samples are not official samples. Samples collected under the Drug

Quality Sampling and Testing (DQST) program are examples of survey samples.

4.1.7 – Non-Regulatory Sample

Non-regulatory samples are those collected and analyzed by the FDA for other federal, state, or local agencies of 

products over which the FDA has no jurisdiction.

4.2 – Dealer Interactions 

Maintaining a positive professional interaction with the dealer helps to facilitate the sample collection.

4.2.1 – Dealer Definition and Good Will

For sample collection purposes, the dealer is the person who has possession of a particular lot of goods. The dealer 

does not have to be a firm or company in the business of buying or selling goods. It may be a private individual, a 

physician, or a public agency—individuals or parties who obtain products to use, but not to sell. The dealer may also be 

a party who does not own the goods, but has possession of them, such as a public storage warehouse or 

transportation agency.

Establishing good rapport with the dealer is important to the success of your objective. All dealers, including hostile 

ones, should be approached in a friendly manner, and treated with fairness, honesty, courtesy, and consideration. A 

dealer may be called as a government witness in a court case, and a favorable attitude on their part is to be sought. 

Never use strong-arm tactics or deception, but rather be professional and demonstrate diplomacy, tact, and 

persuasion. Do not make unreasonable demands.

Consider the following suggestions to promote positive exchanges with dealers:

1. Introduce yourself to the dealer by name, title and organization.

2. Present your credentials for examination, and, if appropriate, issue an FDA 482, Notice of Inspection. See 

5.1.1.3, and 5.2.2. 

3. Explain the purpose of your visit. Be prepared to answer the dealer's questions and attempt to relieve any 

apprehensions while at the same time being careful not to reveal any confidential information. 

4. Do not disparage the product, its manufacturer, or shipper. 
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5. Do not reveal the suspected violation unless the dealer is responsible, or unless you ask him/her to voluntarily 

hold the goods. The very fact we are collecting a sample is often reason enough to arouse the dealer's 

suspicions about the legality of the product.

6. In the instance that an FDA 482 is not necessary for collecting a sample, but the dealer requests one anyway, 

go ahead and issue the requested FDA 482. Attach a copy to the C/R. See IOM 4.6.4.

4.2.2 – Dealer Objection to Sampling Procedure 

If the dealer objects to your proposed sampling technique, attempt to reach a reasonable compromise on a method 

that will provide a satisfactory, though perhaps not ideal, sample. Assure the dealer that you will make every effort to 

restore the lot to its original state, that you are prepared to purchase a whole unit to avoid leaving broken cases, and 

that the agency will reimburse them for additional labor costs incurred as a result of sampling. See IOM 4.2.8. If a reasonable compromise cannot be reached, proceed as a refusal to permit sampling. 

4.2.3 – Refusal to Permit Sampling 

Challenges to FDA authority while collecting samples may be encountered by a dealer who, for various reasons, 

including both personal and professional ones, opposes the activities of the agency, or of governmental units in 

general.

Refusals to permit sample collection commonly emerge unless you can identify a section of the law which specifically 

authorizes it. The suggested approach for dealing with these individuals is to use patient, tactful persuasion, pointing 

out that the sample is a part of the investigations authorized in Section 702 of the FD&C Act [21 U.S.C. 372]. If you have 

not already done so, issue an FDA 482, Notice of Inspection, (except in the case of foreign inspections – see IOM 5.1.3) 

as soon as it becomes apparent the dealer will continue to object. 

Point out and discuss the authorities provided by in the following FD&C Act sections: 702(a), 702(b) [21 U.S.C. 372(a) 

and (b)] and 704(a), 704(c), 704(d) [21 U.S.C. 374(a), (c), and (d)] and the precedent case mentioned in IOM 2.2.1. If 

refusal persists, point out the criminal prohibitions of Section 301(f) of the FD&C Act [21 U.S.C. 331(f)]. 

If samples are still refused, leave the premises, and contact your supervisor immediately. Refer to IOM 5.2.5 and 

Compliance Policy Guide manual section 130.100 for further discussions on resolving the impasse.

If an FDA 482 has been issued prior to a sample refusal situation, the copy of the FDA 482 is to accompany the EIR, or a 

memorandum outlining the facts of the refusal if no EIR is prepared. If you are on a foreign inspection in which an FDA 

482 is not issued, reference relevant Compliance Programs and Chapter 3 of the Guide to International Inspections and 

Travel Manual for reporting guidance. 

4.2.3.1 – Limiting or Preventing Collection of Samples of a Drug 

Preventing an authorized representative of the FDA from collecting drug samples may be considered as limiting the 

inspection. If you have appropriately issued an FDA 482, Notice of Inspection, and the dealer impedes your ability 

to collect samples, point out and discuss the authority provided by Section 501(j) of the FD&C Act [21 U.S.C. 351(j)]

under Section 707 of the Food and Drug Administration Safety and Innovation Act (FDASIA), that potentially deems 

all drugs manufactured at the facility adulterated in the case of limiting an inspection. In situations where you have 

begun an inspection, but no FDA 482 is issued (e.g., foreign inspections), document this fact and the limiting 

activities in your notes based on the authority described above.

If refusal persists, point out that adulteration under Section 501(j) of the FD&C Act [21 U.S.C. 351(j)] could lead to 

further prohibited acts under Section 301(a), (b), and (c) [21 U.S.C. 331(a), (b), (c)]).

Also see IOM 2.2.1.4.
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4.2.4 – Carrier In-Transit Sampling 

Caution: First see IOM 4.3.3 for conditions that must be met before collecting in-transit samples from common 

carriers. 

When collecting samples from in-transit lots in possession of a commercial carrier, issue the carrier or the carrier’s

agent an FDA 482. Attach a copy to the copy of the C/R. See IOM 4.6.4.

4.2.5 – Receipt for Samples 

When you collect a sample after issuing an FDA 482, Notice of Inspection, always issue the appropriate sample receipt

FDA 472, Carriers Receipt for Samples, or FDA 484, Receipt for Samples. The receipt is to be issued to the owner, 

operator, or agent-in-charge, upon completion of the inspection, but prior to leaving the premises. 

Always issue an FDA 484 for samples of prescription drugs, including narcotics and controlled substances. See IOM 

4.2.5.3, 4.2.5.4, and 5.2.4.

Note: There are several situations in which you should not issue an FDA 482 and FDA 484. For example, an FDA 482 or 

FDA 484 should normally not be issued for induced, undercover, or online samples. In addition, check with your 

division/program policy on issuing an FDA 482 and FDA 484 while collecting surveillance samples at retail 

establishments (e.g., grocery store, big-box retail store). 

4.2.5.1 – Carriers/In-Transit Lots 

See an example FDA 472, Carrier’s Receipt for Sample, under IOM Exhibit 4-4. Give the original receipt to the 

carrier or the carrier’s agent. See ORA SOP-000530, Sample Obligation and Processing concerning payment for 

samples for routing of FDA 472.

4.2.5.2 – Dealer Requests Receipt

When collecting physical samples of regulated products not in connection with an establishment inspection (EI) or 

in instances where no FDA 482 has been issued, do not routinely issue an FDA 484, Receipt for Samples, except for 

prescription drugs, narcotics, and/or controlled substances. See IOM 4.2.5.3 and 4.2.5.4. If any dealer specifically 

asks for a receipt, prepare, and issue an FDA 484, and route a copy with records associated with the C/R. See IOM 

4.6.4. 

4.2.5.3 – Narcotic and Controlled Rx Drugs 

Regulations of the Drug Enforcement Administration (DEA) impose strict controls and comprehensive recordkeeping requirements on persons handling narcotics and controlled substances. As a result, an FDA 484 must be 

issued for all samples of such drugs collected by the FDA.

Each dealer in narcotic and controlled drugs is assigned its own unique DEA registration number. Any time you 

collect a sample of a narcotic or controlled drug, be sure the dealer's DEA registration number is entered in the 

appropriate block of the FDA 484. Be sure to double check the number for accuracy, as an error on your part may 

result in possible investigation for drug shortages.

When samples of narcotic or controlled drugs are collected, the complete DEA registration number must be 

entered under the FIRMS DEA NUMBER block on the FDA 484, and the Receipt for Samples given to the person 

from whom the samples were collected.

When completing the FDA 484 for samples of narcotic or controlled drugs includes the trade and chemical name; 

strength of drug; sample size; container size; lot, batch, or control number; manufacturer's name and address; 
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division address and the sample number. See IOM 4.6.4. Use of the FDA 484 as a Receipt for Samples of these 

drugs has the approval of DEA. (See reverse of FDA 484).

4.2.5.4 – Prescription Drugs (Non-Controlled) 

Issue an FDA 484, Receipt for Samples, when samples of prescription drugs are collected from dealers, individuals, 

or during inspections. Attach a copy of the FDA 484 to the C/R. See IOM 4.6.4.

4.2.5.5 – Preparation of FDA 484 

Exhibit 4-5 provides instructions for completing the FDA 484, Receipt for Samples, and an example of a completed 

FDA 484.

4.2.5.6 – Routing of FDA 484 

The signed original Receipt for Samples (FDA 484) should be given to the firm, preferably to the individual you gave 

the FDA 482 and FDA 483 (as applicable). See IOM 4.2.5.3 regarding receipts for narcotics and controlled drug 

samples.

Copies of the FDA 484 should be attached to the C/R and to the establishment inspection report (EIR) if the sample

was collected during an inspection. 

An FDA 484 attached to the C/R can be used to avoid repetition of the descriptions of the subsamples when

numerous subsamples are collected. If you use an FDA 484 for this purpose, be sure the numbers you assign to the 

physical subsamples match those on the FDA 484, and that the sub-descriptions are adequately described. See 

IOM Exhibit 4-5. If errors are noted after issuance, handle the same way as instructed per IOM 5.2.3.1.6.1 and IOM 

5.2.3.1.6.2. Also, the Remarks section of the C/R should include notation of this practice if used.

4.2.6 – Dealer Identification of Lot and Records 

Positive identification of sampled lots and the records covering their sales and shipment are essential to legal 

proceedings. The dealer's identification of a sampled lot and their identification of the records covering interstate

shipment should be factual and specific. If there is any question about accurate identification of the lot or records, be 

sure to determine all facts and establish identification as clearly as possible. Be alert to any identifying marks, too, 

which may later be used on the witness stand for positive identification.

4.2.6.1 – Private Individuals 

When collecting official samples from private individuals, ask the individual to initial and date the label, wrappings, 

promotional literature, etc. This will aid in positively identifying the product and related documents in any court 

proceedings that may develop months, or even years later.

4.2.6.2 – Seriously Ill Individuals 

If you collect samples from an individual for contemplated regulatory action, and it is obvious the individual is 

seriously ill, you should attempt to locate and obtain a corroborating statement and identification from someone 

else. This corroborating witness should have personal knowledge of the facts and be available if the principal 

witness cannot testify in a legal proceeding.

4.2.7 – Sampling from Other Government Agencies 

IOM subchapter 3.2 for sampling information specific to other government agencies (OGA).

4.2.8 – Payment for Samples 

Payment for all samples, except those collected under authority of a court order or decree, shall be offered to the 

individual from whom the sample(s) were obtained regardless of the amount. See IOM 4.2.8.2.
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An exception to this is import samples. The FDA does not pay for import samples at the time of collection. The 

importer should bill the appropriate division office. The FDA will not pay for violative import samples. See 21 CFR 1.91. 

4.2.8.1 – Post Seizure (PS) and Reconditioning Samples under Court Order 

You should not pay for, or offer payment for, any post seizure (PS) or other similar sample-- including those from 

reconditioned lots--if collected under authority of a court order or decree. If the dealer insists on payment before 

permitting sampling, show them the court order. If you are still refused sampling, contact your supervisor 

immediately for further instructions. You may be instructed to notify the U.S. Attorney.

4.2.8.2 – Determining Sample Cost 

If you are collecting samples from firms or the representatives of firms who have federal supply, Veterans 

Administration, or other contracts with the federal government, the cost of the sample shall be determined by the 

scheduled price. Inquire of the firm if it is on contract for the item. If so, pay only the scheduled price.

Some dealers may wish to charge their regular selling price. However, if the cost of the sample seems excessive, try 

to persuade the dealer to charge a lower price that is more equitable. If asked, inform the dealer that the 

government considers a fair price to be the dealer's invoice cost plus a nominal charge (usually 10-15%) for freight, 

handling, and storage.

If you are unable, through tactful discussion, to convince the dealer to lower the sample cost, do not haggle over 

the price to be paid. If the cost seems exorbitant, check with your supervisor to determine if the sample size can be 

reduced, or for further instructions. Whenever there is a disagreement over sample cost, ask the dealer to bill the 

division and report the circumstances in the collection remarks field on your C/R. 

If divisions encounter requests for payment for method validation samples (either direct submission by firms to 

labs or during collection from responsible firms), they should contact the appropriate Office of New Drugs in CDER

or CVM, so that communication may take place with the application sponsor. If product is being collected from 

commercial distribution not in the control of the sponsor/manufacturer, then the division should expect to pay 

wholesale cost. Expenses for new drug application (NDA) method validation samples should be charged to a 

Prescription Drug User Fee Act (PDUFA) reimbursable central account number (CAN). 

4.2.8.3 - Method of Payment 

There are two main ways to pay for samples. The sample costs may be billed to the division, or cash may be used 

to pay for the sample. Encouraging dealers to bill the division is the preferred method for paying for samples. You 

can also use your personal credit card to pay for the sample. While ORA policy currently allows for you to pay for 

samples with your own personal funds then submit for reimbursement, you should speak to your supervisor about 

alternatives prior to using personal funds to pay for a sample. See IOM 4.6.2.45 and 4.2.5.5.

4.2.8.3.1 - Costs Billed to Division 

Billing sample costs to the division is, in many instances, the most practical method of payment. This is 

particularly true where substantial costs are involved due to large sample size; expensive samples; the samples 

collected involve third parties, such as carriers and public storage warehouses; or in instances when delivery 

followed by subsequent billing is the dealer’s normal business practice. 

Sampling from public storage warehouses and common carriers incurs costs that are normally billed because 

the owner of the product is unavailable. Determine the identity of the owner or the owner’s agent and 

estimate the value of the goods sampled. Arrange with the owner or owner agent to bill the division.
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ORA SOP-000530, Sample Obligation and Processing, describes the process for paying invoices to the division 

for samples. There are two related documents that investigators should provide to the firm when the firm will 

bill the division. One is Form-000870, a Vendor Process Payment Letter, and provides guidance to the vendor 

how to send their bill to the FDA. The other is Form-000874, a list of DFA contacts that the dealer should 

submit information to. These forms can be provided in hard copy at the time of sample collection or e-mailed 

to the firm after sample collection. If the forms are e-mailed, be sure to download the form to your computer 

and share the actual document (and not the links provided here). You should keep in mind that the links are 

dynamic and the information in them may change. Be sure that you give the dealer the current letter and 

contact. 

4.2.8.3.2 - Cash Payment 

As previously noted, you are expected to encourage the dealer to bill the division for the cost of the sample. 

Obtaining cash to purchase samples should be used as a last resort when other methods of payment are not 

available. You can use personal funds to purchase samples. It is not mandatory to use personal funds. If you 

choose to use personal funds, speak to your supervisor before doing so. You will not be able to obtain 

reimbursement via a local voucher. Reimbursement for samples paid for from personal funds will be made via 

submission of an OF-1164 form as described under the Division of Financial Operations (DFO) Budget 

Execution procedures. 

Sample costs cannot be charged directly to your government credit card. Using your government credit card to 

obtain a cash withdrawal is not ideal. However, you can use your government credit card to withdraw an ATM

advance to pay for your sample, whether or not you are in travel status. You are required to obtain your 

supervisor’s approval (via email or other written form), prior to using your government credit card, to make a 

cash withdrawal to purchase samples. The amount of the withdrawal should be limited to the cost of the 

sample. You should submit your itemized claim for samples along with the cash withdrawal fee, as applicable,

by submitting a local voucher using the electronic travel management system. Include the following 

information and documentation when submitting the local voucher for reimbursement: sample number, 

receipt for the sample purchase, receipt showing the cash withdrawal fee if applicable, and approval from your 

supervisor to use the government credit card. 

4.2.8.3.3 - Online Payment 

Online samples, if they are undercover buys, should be paid for using a dedicated and unidentifiable FDA credit 

card. Other special assignment online samples should be paid for using a district or division P-card. The 

sampling assignment should provide guidance for an online payment. If guidance is not found in the 

assignment, check with your supervisor for program or division specific procedures to pay for online samples.

Do not use your government travel or personal credit card to pay for online samples.

4.2.8.4 – Sampling – Labor Charges 

Additional labor, such as use of forklift, or other assistance may be required to move merchandise, skids, pallets or 

perform other actions, to properly sample and restore a lot. Usually, assistance with such labor will be available on 

the premises from the firm’s employees. If you determine assistance is needed but unavailable at the firm, contact 

your supervisor to determine next steps. 

There is usually little need to discuss payment when requesting nominal use of labor or equipment. However, if 

there is an indication that firm management expects payment, attempt to reach a clear understanding of the 

charges before proceeding. If the charges to be incurred appear reasonable, and the cost is minor (about $25.00 or 
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less), proceed with the work and add the charges to your sample cost. However, if substantial costs are involved, 

consult with your supervisor before making a commitment to pay.

Where the charges are substantial and have been authorized by your supervisor, arrange for the cost of labor 

and/or machinery to be billed to the division. Handle these charges separately from the actual cost of the sample. 

Determine the hourly rate and keep track of time, labor, and/or machinery used. Prepare a short memo outlining 

the charges and submit it to your division.

4.2.9 – Dealer Voluntary Hold 

This section deals solely with a voluntary hold on regulated products. See IOM 2.7.1 for specific statutory authorities 

for detaining meat, poultry, egg products, and medical devices.

There is no specific authority for requesting a voluntary hold on a lot but, voluntary holds by a dealer shall be 

encouraged in instances where the lot sampled is clearly adulterated. By voluntarily holding, the dealer prevents 

further distribution of suspected violative goods until seizure or other appropriate action can be accomplished.

4.2.9.1 – Perishable Goods 

Except in rare instances, it is generally not practical to hold highly perishable items unless the analysis can be 

completed within 24 hours. You should confer with your supervisor before requesting a voluntary hold on perishable items.

4.2.9.2 – Obtaining a Voluntary Hold 

When the lot is clearly adulterated, or when instructed to do so by your supervisor, request that the dealer 

voluntarily hold the product. Explain the rationale for the request and a potential timeframe for the hold. If the 

dealer objects, discuss their responsibility under the law and the public health consequences that may result. If the 

dealer indicates a reluctance to voluntarily hold the lot, call their attention to Section 301(a) of the FD&C Act [21 

U.S.C. 331(a)]. 

Since the action is voluntary, we cannot require the dealer to do all the things we might ask them to do. While 

requests for voluntary holds are generally granted, a dealer may act or suggest an alternative approach.

Always place a time limit on voluntary holds using your best estimate of how long it will approximately take to 

complete the analysis and reach a division decision. In estimating this time frame, you’ll want to consider such 

factors as: location of the examining lab, difficulty of the analysis required, turnover rate, storage conditions, and 

the perishable nature of the merchandise. Note: Your division's compliance branch can request an extension of the 

voluntary hold. Also, be sure to document the voluntary hold in your regulatory notes and in the dealer’s affidavit. 

Also note the following special situations and/or potential responses from a dealer regarding voluntary holds:

If the dealer declines to hold the lot, but proposes returning it to the shipper, the dealer should be warned NOT to 

return the goods to the shipper and advised that the FDA does not condone shipping violative goods. Direct their 

attention to Section 301(a) of the FD&C Act [21 U.S.C. 331 (a)]. 

If the dealer offers to voluntarily denature or destroy the lot in lieu of voluntary hold you should provide or 

arrange for supervision/oversight of the denaturing per IOM 2.8.1. If the dealer proposes to recondition the lot

themselves, refer them to your division compliance branch for approval of their method. See IOM Subchapter 2.6 

and IOM 2.6.3.
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If the dealer still refuses, discuss the situation with your supervisor. A state embargo (see IOM 3.3.1) or 

administrative detention (IOM 2.5.11) may be the next action. 

4.3 - Collection Technique 

In most cases, when collecting a sample, you must ensure that the sample collected is a good representation the 

dealer’s lot. The goal of collecting a sample for laboratory analysis is to provide the laboratory a part of a lot that 

represents the overall lot. This means that the way you collect the sample, as well as all the activities involved before it 

arrives at the lab, should leave the product in the sample, and in the same state, as the product that remains at the 

dealer. So, for example, a refrigerated sample collected for microbiological analysis should remain refrigerated until it 

is delivered to the laboratory.

4.3.1 - Lot Restoration and Identification 

4.3.1.1 - Restoring Lot(s) Sampled 

After completion of your sample, restore lots to their original condition. Do not leave partially filled shipping cases, 

or short-weight or short-volume containers in the lot after sampling. Do not leave the lot in any condition that

might encourage pilferage or make it unsalable.

When collecting from either full cases or bulk containers, replace sampled units by back-filling from a container 

selected for that purpose. Avoid contaminating the back-filled units. If necessary, correct the contents’ declaration 

on the containers that were sampled to reflect the actual contents now present. Refer to IOM 4.2.2 if the dealer 

objects to back-filling because of company policy, different codes involved, or for other reasons. As a last resort, 

accede to the dealer's wishes and sample intact units, but record the facts in your regulatory notes and place a 

brief explanation on the C/R.

After collecting your sample, carefully re-close all containers and shipping cases. If necessary, request assistance 

from the dealer's employees to help restore the lot, or arrange, through the dealer, to employ outside help. See 

IOM 4.2.8.4.

4.3.1.2 - Identifying Lot(s) Sampled 

Identify each container from which units are taken with the date, your initials, and the sample number. NOTE: For 

import samples, identify each master container from which units are taken with the following information: FDA, 

division abbreviation, sample date, and the lead investigator’s initials.

Should the dealer object to your identification procedure, attempt to reach a compromise, such as, placing the 

identification in an obscure location. If the dealer still objects, accede to their wishes, but record the facts in your 

regulatory notes.

Positive identification of the containers sampled is important if it becomes necessary to resample the lot(s), or if a 

detention, seizure, or other action ensues. It also aids the dealer in differentiating between containers that have 

been opened by the FDA, as opposed to those opened by pilferage or torn open by rough handling. It may be 

necessary to mark more containers than sampled to assure proper identification of the lot, for example when a lot 

may be split for distribution after sampling. This must be done by using permanent identification, for example, 

through handwritten identification or by using a rubber stamp.

Note that many inks have the potential to penetrate the product and act as a contaminant, interfering with the 

analysis. As such, do not use markers on sample containers that allow for any penetration into the product.
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Many inks will penetrate to the product and act as a contaminant, interfering with the analysis. Do not use markers 

on sample containers which allow penetration into the product.

Water base markers will run when damp and must be covered with tape. 

Do not permanently identify articles that are borrowed and will be returned to the dealer.

See 4.7.2.3 for identification techniques.

4.3.2 - Sample Size 

To determine sample size, first consult your assignment. If the assignment doesn't specify the sample size, follow the 

guidance in the applicable Compliance Program. The IOM SAMPLE SCHEDULE (found at the end of this chapter after 

the Exhibits), should be used if the Compliance Program doesn't state the sample size. If none of these sources furnish 

the sample size, consult with your supervisor or the relevant laboratory. Also, collect sufficient sample when necessary 

to allow for the 702(b) portion if appropriate. See IOM 4.3.2.2 and 4.3.2.3.

4.3.2.1 - Medical Device Samples 

The following table represents the devices for which there are instructions on physical sampling in Compliance 

Policy Guides:

Device CPG Reference

Clinical Thermometers See CPG 335.800

Condoms See CPG 345.100

Surgeons and Patient Exam Gloves See CPG 335.700

In addition to providing instructions on sample size, these compliance policy guides provide guidance on criteria to 

determine adulteration and whether or not regulatory action should be recommended. 

Also see the following references with regards to collecting medical device samples:

WEAC-MEMO-2012-04-13.01_Medical Device Sampling Guidance Memo and OEIO Field Examination, Label 

Examination, and Sampling Work Instructions. 

Review your assignment and, if needed, discuss it with your supervisor prior to collecting physical samples of 

medical devices.

4.3.2.2 - 702(b) Requirement 

Under section 702(b) of the FD&C Act (21 U.S.C. 372(b)), when the FDA collects a sample of a food, drug, or 

cosmetic for analysis, FDA must, “upon request, provide a part of such official sample for examination or analysis 

by any person named on the label of the article, or the owner thereof, or his attorney or agent.” 

When the sample schedule, assignment, or other instruction does not specifically provide for the 702(b) portion, 

collect a sufficient amount to provide this required portion and indicate duplicate availability in the FACTS C/R by 

checking the 702(b) box. You are not required to obtain a 702(b) portion in the following instances exempted by 

statute or by regulation 21 CFR 2.10(b): 
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1. Devices and tobacco products are not included in the statutory requirement of Section 702(b). 

2. The amount available for sampling is less than twice the quantity estimated to be sufficient for analysis. 

If this is the case, collect all that is available.

3. The cost of twice the quantity estimated to be sufficient for analysis exceeds $150.00. If the sample is 

critical, and the cost exceeds $150.00, consult with your supervisor.

4. The sample cannot, by diligent use of practicable preservation techniques available to the FDA, be kept 

in a state in which it could readily and meaningfully be analyzed in the same manner and for the same 

purposes as the FDA’s analysis. Examples of this include fresh produce, water samples, and 

environmental swabs. If you are at all unclear on this point, consult with your supervisor, or servicing 

laboratory, to confirm that practicable preservation techniques are indeed not available.

5. The sample is collected from a shipment being imported or offered for entry into the United States 

(import samples). 

6. The sample is collected from a person named on the label of the article or their agent, and such person 

is also owner of the article. For example, it is not necessary to obtain a 702(b) portion if the sample is 

collected from a lot owned by and in the possession of the manufacturer whose name appears on the 

label.

7. The sample is collected from the owner of the article or their agent, and the article bears no label--or if 

it bears a label, no person is named on it. 

In the remarks section of the C/R, describe the specific circumstances and justification for not collecting the 702(b)

portion. The documentation is not needed if the product is a device or tobacco product, or the assignment or 

compliance guide already states why the 702(b) portion is not needed.

Note regarding filth samples: Regardless of the exemptions under 21 CFR 2.10(b) listed above, collect the 702(b)

portion for filth samples, unless your supervisor directs otherwise.

4.3.2.3 - Collecting the 702(b) Portion

As noted already, whenever possible, collect separate subsamples in order to provide the firm a portion as 

required by Section 702(b). Each duplicate subsample should be collected from the same bag, box, case, or 

container. The total sample should be at least twice the quantity estimated to be sufficient for analysis, including a 

reserve portion for the servicing FDA laboratory. If unable to collect separate subsamples, ensure that the total 

amount collected for each sample subsample, or the total amount collected from an undivided sample, is at least 

twice the amount estimated to be sufficient for analysis. See IOM 4.6.2.58. 

4.3.3 - In-Transit Samples 

The exterior of any domestic package thought to contain an article subject to FDA regulation and in the possession, 

control, or custody of a common carrier may be examined (to include being photographed, information on the outside 

copied, etc.), and records of the shipment may be obtained. However, such package may not be opened by an FDA 

employee, or by an employee of the common carrier at the request of an FDA employee, except as provided below.

4.3.3.1- Examination without a Warrant

The Office of Chief Counsel has advised that FDA employees may--without a warrant--open, examine the contents 

of, and/or sample a package that is part of a domestic commercial interstate shipment in the possession, control, 

or custody of a common carrier only if:
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• The consignor or consignee affirmatively consents to examination and/or sampling of the contents; or the 

agency has reliable information that the carrier regularly carries FDA-regulated articles, and the facility 

where the sampling is contemplated is subject to FDA inspection. Reliable information may come from 

agency files, the carrier itself, other customers of the carrier, etc., and 

• The Agency has reliable information that a particular package sought to be examined is destined for, or 

received from another state, and contains an FDA-regulated article. [Such information may be found on 

the exterior of the package and/or shipping documents in specific terms. Information may also come from 

a reliable source that establishes the consignor is in the business of manufacturing and/or shipping FDAregulated articles using a distinctive type of package (shipping container), and the package in question 

meets such description and shows the consignor to be such firm.]

4.3.3.2 - Examination with a Warrant

Confer with your supervisor on any question concerning the need for an inspection warrant to examine the 

contents and/or sample an in-transit package. Your Compliance Branch should be consulted if criteria for 

requesting a warrant are not clear. 

If a decision has been made to recommend a warrant, the Office of Policy, Compliance and Enforcement, Division 

of Compliance and Enforcement (OPCE/DCE) should be contacted. Follow the procedures outlined in the 

Regulatory Procedures Manual 6-3.

If a common carrier reports a violative article that it discovers under its own package-opening procedures, 

independent of any request by an FDA employee or any standing FDA cooperative program with the carrier, the 

FDA may still need an inspection warrant to examine the material. Unless all the conditions for independent 

sampling in IOM 4.3.3.1 exist, you must consult with your supervisor, who can arrange for a headquarters 

consultation as outlined above.

Note: Where the identity of an interstate product is known or apparent--by virtue of it being visible in bulk or 

being in labeled containers or packages whose contents can be verified by shipping records, and where such 

product is under FDA jurisdiction at a given location--it may be sampled according to established IOM procedures.

4.3.3.3 - Resealing Conveyances 

If it is necessary to break the commercial seal to enter a railcar or other conveyance, reseal the door with a 

numbered self-locking "U.S. Food and Drug" metal seal. Record in your regulatory notes (and on C/R if sample

taken) the number of the car or conveyance, the identifying number on any car seals removed, and the number of 

the FDA metal seal applied.

4.3.4 - Special Sampling Situations 

There will be situations that arise where the dealer may need to sample product for you due to safety and/or other 

concerns. After evaluation of the situation and prior to allowing dealer sampling, contact your supervisor for 

appropriate guidance and concurrence. If permissible, all dealer sampling must be done with your direct oversight. 

Note dealer sample collection in your C/R.
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Do not collect human or animal biological materials (for example, urine, feces, sputum, blood, 

blood products, organs, tissues) or FDA-regulated products potentially contaminated with 

biological materials unless arrangements for special handling and special treatment have been 

made in advance with the ORA Safety Office. Most ORA-servicing laboratories are not prepared 

or certified to handle these materials. In addition to guidance for special sampling situations 

provided below, sampling guidance may also be found in IOM Subchapter 1.5 – Safety under IOM 1.5.3 - Sampling.

Some products like essential oils should not be collected in plastic containers or paraffin-coated caps. Use glass, cork, 

foil covered, or non-plastic, non-paraffin closures. If unsure of the appropriate container/lid type, contact your 

servicing lab for guidance.

Please contact your servicing lab to determine an appropriate sampling container and sample size for medicinal and 

other gases.

4.3.4.1 - Samples Collected During Investigations of Complaints, Counterfeiting, Tampering, 

Foodborne Disease, and/or Injury/Illness

Detailed instructions for investigating and sampling products in connection with consumer complaints, tampering, 

foodborne outbreaks, injury, and adverse reactions, etc., appear in Chapter 8 of the IOM.

Be cognizant of conserving scarce resources when investigating consumer complaints that do not involve injury, 

illness, or product counterfeiting/tampering. Unnecessary samples waste both operational and administrative 

resources. For example, there is little need to collect a physical sample of an insect-infested box of cereal from a

complainant. Both you and the consumer can readily see it is insect infested. The laboratory would also find it 

insect infested. No practical purpose would be served by either collecting or examining such a sample.

Photographs can be used to document the infestation.

During consumer complaint investigations/follow-up events--when blood or body fluid contamination is suspected, 

and when there is no apparent illness or injury--samples should not be collected without first contacting 

Emergency Operations. This is due to the lack of confidence in the analytical methods and the results associated 

with certain blood and body fluid samples. As such, the decision to collect a sample will be made on a case-by-case 

basis, and in consultation with the Office of Regulatory Science, Emergency Operations, and the Office of Medical

Products and Tobacco Operations.

4.3.4.2 - Undercover Buy Samples

If this sample type is desired, your supervisor will provide specific instructions and procedures to be followed. This 

planning will likely involve the following factors or questions:

1. Whether to use your correct name or an alias. Caution: if you use an alias, do not use a similar name or a name 

with initials the same as yours (for example., Sidney H. Rogers should not use Samuel H. Right). In addition, 

do not use a division office or resident post as a return address when ordering products or literature.

2. Whether to use order blanks contained in the promotional package, advertisement, or promotional activity; or 

whether false ones will be used.

3. Whether money orders, your credit card numbers, bank checks, or your personal checks should be used for 

payment. It depends on the situation, but money orders are preferred since these do not involve personal 

accounts.
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4. Where the requested items are to be sent. For example, will you use a rented P.O. Box, home address, General 

Delivery, etc.

5. How the address and/or your name is to be recorded on the order blank. A code may be used either in your 

name or address, so any follow-up promotional material sent to that name and address can be keyed to 

your original order.

Do not telephone your order in from the office or your home phone because the firm may have "Caller ID" and be 

able to identify your location by the phone number. For samples induced online, use a non-FDA network 

computer. 

When it has been decided to induce a sample and you have discussed the procedures with your supervisor, 

prepare the order and obtain the money order, or other payment document. When all documents for ordering the 

item(s) are prepared--photocopy all the materials, including the addressed envelope, for your C/R--and submit the 

order.

When the order is received, identify the sample item; all its accompanying materials, such as pamphlets, 

brochures, etc. (including all wrappings containing any type of printing, identification, numbers, post-marks, 

addresses, etc.); and submit the item and exhibits in the same manner as any other official sample. If payment of 

the item was by personal check or credit card number, attach a photocopy of the canceled check or credit card 

receipt, if available. You may do this later, after clearance of the check or charge slip. Samples induced online 

should include a record of the purchase process, including point of sale, relevant emails, and documentation of 

where and how the sample was received and collected.

4.3.4.3 - Collecting Surveillance Samples on Farms

Specific instructions have been developed for the collection of surveillance samples on farms or from on-farm 

packinghouses or processors, including pre-notification, interaction with the farm personnel, payment for samples 

collected on farms and sample size(s). Though these instructions only apply to surveillance samples, they may also 

be considered for illness investigations or for cause sampling but are not required.

On farm sample collections should be limited to instances where it is specifically mentioned in an assignment. 

When you are planning to collect surveillance samples on a farm, you should call the farm at least 24 hours in 

advance to notify the farm of FDA’s intent to collect samples and share the commodity of interest. 

During the pre-notification call, the investigator should also determine an estimate of what the sample(s) will cost

if the farm decides to charge for the samples. The investigator will take enough cash to cover the cost of the 

samples collected and not ask the farm to bill FDA as may be done in other sampling situations. If the farm decides 

to charge for samples and you did not bring cash, use the government travel card to withdraw cash from an ATM

and withdraw the exact amount needed to cover the cost of the samples. As a last resort, personal funds may be 

used, do not ask the farm to bill FDA.

If the investigator collecting the sample is a PHS Commissioned Officer, the investigator will explain to the farm 

representative that he/she will be wearing his/her uniform. During this conversation, the officer will describe the 

uniform he/she will be wearing (e.g., blues, khakis) and also explain why the officer wears the uniform as a 

Commissioned Officer in the Public Health Service.

When on farm and viewing the inventory of product to be collected, the investigator will determine if the sample

size needed will exhaust the farm’s supply of the product or may cause the farm to not be able to meet customer 

needs. If so, consideration should be given to not collecting the sample or if possible, modifying the size of the 
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sample. If the sample collection will exhaust the entire inventory, the investigator should discuss this with 

responsible farm management and determine how soon inventory will be restored and if the farm management

believes the sample collection will impose an economic disadvantage to the farm. If the responsible party states 

that it will cause an economic disadvantage, the investigator should not collect the sample at that time, but rather 

plan to return at another time when additional inventory will be available for sampling or consider selection of 

another site for collection.

Samples collected from farms should be identified as Investigational (INV) and interstate commerce is not 

necessary. Produce samples collected from farms do not require the collection of a 702(b) portion.

4.3.4.4 - Collecting Feed Samples for Bovine Spongiform Encephalopathy (BSE) Analysis 

You need to be aware of proper safety procedures for collecting, packaging and shipping 

domestic and imported feed samples. The main objective of safety recommendations is to 

minimize exposure to feeds and feed dust at the time of sample collection and to minimize future 

exposure through feed dust on clothing or equipment. Please contact ORA Safety Office for 

available safety trainings. See IOM Chapter S – Safety.

Safety precautions should be followed for ALL sample collections for BSE analysis, both import and domestic. Use 

of these procedures will also minimize exposure risk to other potential pathogens. Given the risks associated with 

exposure to both BSE and other pathogens, you are strongly encouraged to follow safety procedures whenever 

any dusty feed samples are collected. and it is encouraged to follow these procedures whenever any dusty feed 

samples are collected.

Minimizing dust exposure can be accomplished as follows: 

• Use of recommended personal protective equipment (PPE) to be used by personnel collecting feed

samples: 

1. Respiratory protection: at a minimum half-mask air-purifying respirator (face-sealing) with P100 

filters (HEPA) 

2. Ocular (eye) mucous membrane protection: goggles 

3. Percutaneous (through skin openings such as cuts, abrasions- unbroken skin poses no known 

hazard) – waterproof gloves on hands; cover skin lesions, cuts, abrasions with waterproof dressing 

4. Clothing contamination – disposable coveralls 

• Collection and bagging procedures: 

1. Minimize dust as much as possible when collecting 16 – 1 oz subs and combining them into one 

sample. 

2. Wipe the outside of whirl-pak bag with a water-dampened paper towel in a clean area and place 

this bag into another whirl-pak bag (double bag the sample). 

• Cleanup and PPE removal: 

1. When in a dust-free area, remove the disposable coveralls by turning inside-out, rolling up and 

placing in a plastic bag for disposal. 

2. Wipe shoes with water dampened paper towel. 
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3. Remove goggles and respirator; wipe outside of goggles and respirator with water-dampened 

paper towel. 

4. Place goggles and respirator in clean carrying bag. 

5. Place all wipes in the disposal bag with the disposable coveralls. 

6. Place the bag in a trash receptacle on site if the firm permits or carry out and dispose of properly at 

your FDA office.

See IOM Chapter S - Safety, Sections S.9.7, S.9.10, S.13.6 and S.13.10.4.

4.3.4.5 – Collecting Samples During Foreign Inspections 

An FDA 482, Notice of Inspection (Section 704(a) of the FD&C Act [21 U.S.C. 374(a)]) is not required to be issued to 

a foreign facility prior to conducting an inspection or collecting a sample, unless the firm is a U.S. Military facility, 

however; credentials should be presented to the top management official. See IOM 5.1.1.3 and 5.1.3. 

Please note that an FDA 484, Receipt for Samples (Section 704(c) of the FD&C Act [21 U.S.C. 374(c)]), is issued to 

the owner, operator, or agent in charge (OOAC), describing any samples obtained during the course of an 

inspection.

You should follow the specific assignment instructions for sample collection at foreign firms. Consult with your 

program foreign division point of contact for additional guidance for collecting and shipping foreign samples. 

4.3.4.6 – Notification for FDA Samples Collected During a Foreign Establishment Inspection 

or During FDA Activities in a U.S. Territory Outside of the Customs Territory of the United 

States 

When shipping a sample collected during a foreign establishment Inspection or during FDA activities in a U.S. 

territory outside of the Customs territory of the United States (e.g., Guam, American Samoa, etc.), , follow these 

notification procedures: 

FOOD SAMPLE: After the sample has been collected, prepared, and ready for shipment, but before it is delivered 

to the carrier, email the Division of Food Defense Targeting (DFDT) Watch Commanders 

oraoeiodfdtwatchcommanders@fda.hhs.gov and cc the Division of Import Operations (DIO) Information Duty 

Officer (IDO) FDAImportsInquiry@fda.hhs.gov with the following information: 

1. Name of carrier (UPS, FedEx, etc.) 

2. Date to be shipped 

3. Tracking number(s) 

4. Number of packages 

5. Declared contents (Example "FDA Food Sample for analysis") 

6. Product(s): Description of product(s), sample size including individual retail package size (if collected), 

7. FDA Lab and address to be shipped to 

8. Name and office address for the contact point (Person shipping the sample) 

9. Manufacturer: Name and full address of the facility who manufactured the product(s) 

The DFDT will address anything related to Prior Notice (PN). The DFDT is available to file and provide PN 

confirmation numbers 24 hours a day, 7 days a week. Once a PN is filed, the DFDT will provide the PN confirmation 

number by return e-mail so that it can be provided to the carrier at the time sample is delivered for shipment. If 

necessary, the shipper can email or call the DFDT at any time and ask for the Watch Commander on duty. If 
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contacting the DFDT by phone, please call direct @ 571-468-1488 or, if able to call toll free, use 866-521- 2297. If 

any non-PN issues arise with the shipment and importation of the sample, email the IDO. The IDO can facilitate 

communication to the field divisions, through the Division Import Activity Liaisons (DIALS), to help expedite 

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NON-FOOD SAMPLE: After the sample has been collected, prepared, and ready for shipment, but before it is 

delivered to the carrier, email the DIO Information Duty Officer (IDO) FDAImportsInquiry@fda.hhs.gov with the 

following information: 

1. Name of carrier (UPS, FedEx, etc.) 

2. Date to be shipped 

3. Tracking number(s) Number of packages 

4. Declared contents (Example "FDA Sample for analysis") 

5. Product(s): Description of product(s), sample size including individual retail package size (if collected), 

6. FDA Lab and address to be shipped to 

7. Name and office address for the contact point (Person shipping the sample) 

8. Manufacturer: Name and full address of the facility who manufactured the product(s).

If any issues arise with the shipment and importation of the sample, email the IDO. The IDO can facilitate 

communication to the field divisions, through the Division Import Activity Liaisons (DIALS) to help expedite it.

4.3.5 - Aseptic Sample 

Aseptic sampling is often used in the collection of in-line samples, environmental samples, product samples from bulk 

containers and collection of unpackaged product that is being collected for microbial analysis. 

Aseptic sampling is a technique used to prevent contamination by your sampling technique. Aseptic sampling involves 

the use of sterile sampling tools and sterile containers. Good aseptic sampling technique is demonstrated when the 

sample is contacted only by the sterile sampling tools or the sterile container used for sampling. Samples collected 

using good aseptic technique are important as they will support testimony that the bacteriological findings accurately 

reflect the condition of the lot at the time of sampling and, ideally, at the time of the original shipment. Aseptic 

sampling is critical to not only samples that will undergo microbiological analysis, but also to samples subject to 

chemical tests that might be altered by microbial activity. For chemotherapeutics, make sure that the shipping 

conditions ensure that microbial populations remain inactive and do not have the opportunity to degrade the analyte. 

The most ideal approach, whenever possible, is to collect intact, unopened containers. 

Products in 55-gallon drums, or similarly large containers, either aseptically filled or heat processed, should not be 

sampled while the shipment is en route, unless the owner accepts responsibility for the portion remaining after 

sampling. Try, instead, to arrange sampling of these products at the consignee’s location so the opened containers can 

be immediately used or stored under refrigerated conditions. 

For more guidance on aseptic techniques, you may consult the course, Food Microbiological Control 10: Aseptic 

Sampling, available to FDA employees through the OTED Intranet Site. 

4.3.5.1 - General Procedures

If it is necessary to open containers, draw the sample and submit it under conditions that will prevent 

multiplication or undue reduction of the bacterial population. Follow the basic principles of aseptic sampling 

techniques. Take steps to minimize exposure of the product, sampling equipment, and the interior of sampling 

containers to the environment.
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4.3.5.1.1 - Sterilized Equipment

Use only sterilized equipment and containers. These can be purchased sterile, obtained from a servicing 

laboratory, or in an emergency, at local cooperating health agencies. If pre-sterilized metal tools are 

unavailable, the metal tools can be sterilized immediately before use with a propane torch. If using this tool, 

permit it to cool in the air or inside a sterile container before using. Another acceptable method, albeit of last 

resort, is soaking the tools with 70% alcohol and flaming off. Ensure collection controls used are within the 

manufacturer’s expiration date prior to use.

If it is necessary to drill, saw, or cut the item being sampled (such as large frozen fish, cheese wheels, frozen 

fruit, etc.), use stainless steel bits, blades, knives, etc., that can be flame sterilized with 70% alcohol wherever 

possible. Note that wooden-handled sampling instruments are particularly susceptible to bacterial 

contamination (because of wood being of porous nature), are difficult to sterilize, and thus should be avoided.

4.3.5.1.2 - CAUTIONS

Be extremely careful when using a propane torch or other flame when sterilizing tools and 

equipment. Evaluate environmental and other conditions pertaining to explosive vapors, 

dusty air, flame-restricted areas, firm policy and/or management wishes. Also, the use of 

supportive devices should be considered when the torch is not being handheld. In addition,

be sure all flammable liquids, such as alcohol, in your filth kit are in metal safety cans and not 

in breakable containers.

If it is necessary to handle the items being sampled, then use sterile disposable-type gloves. Surgeon's gloves 

are a good choice. Use a new glove for each sub and submit an unopened pair of gloves as a control. See IOM 

4.3.5.5.

4.3.5.1.3 - Opening Sterile Sampling Containers

Plan your aseptic sampling approach, including organizing your sampling tools prior to sampling. When 

opening sterile sampling containers, work rapidly and efficiently. Open sterile sampling containers only to 

admit the sample and close it immediately. Do not touch the inside of the sterile container, lip, or lid. (See IOM 

4.3.4)

4.3.5.1.4 - Dusty Areas 

Do not collect samples in areas where dust or atmospheric conditions may cause contamination of the sample, 

unless such contamination may be considered a part of the sample.

4.3.5.2 - Sampling Dried Powders

Cautions - The proper aseptic sampling of dried milk powder, dried eggs, dried yeast, and similar types of products 

is difficult because they are generally packed in multilayer, poly-lined paper bags. These may be stitched across the 

entire top, may have filler spouts, or the top of the poly-liner may be closed or sealed with some type of "twists".

The practice of cutting an "X" or "V," or slitting the bag and folding the cut part back to expose the contents for 

sampling, should not be used because it creates a resealing problem; the opening cannot be properly repaired.

Note the following procedures have been approved by the scientific units at headquarters, and should be used

when sampling based upon the way the product has been packaged:
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4.3.5.2.1 - Bag And Poly-Liner Stitched Together Across Top Seam

1. Remove as much dust as possible from the seam end by brushing it and then wiping it with a cloth 

dampened with alcohol. Note: This does not sterilize the bag, as porous paper cannot be sterilized.

2. Remove the seam stitching carefully (and dust cover, if any) and spread open the walls of the bag and 

the poly-liner enough to permit sampling--being careful that no extraneous material, such as dust, bits 

of twine, paper, etc., drops into the product.

1. Carefully scrape off the surface of the product with a sterile device and aseptically draw the sample

from the material below.

2. Carefully reclose the bag and re-stitch by hand, or by machine if a firm, or FDA-portable, sewing 

machine is available.

4.3.5.2.2 - Bag Stitched Across Top And Poly-Liner Twist-Closed And Sealed With "Twist" Device - Wire, Plastic, 

Etc.

1. Brush, alcohol wipe, and remove stitching as described above.

2. Remove the "twist" seal and carefully open poly-liner, using caution that no extraneous material drops 

into the product.

3. Draw aseptic sample in same manner as in step 3 above.

4. Carefully close the poly-liner with a twisting motion and reseal with "twist" seal, arranging it so it will 

not puncture the poly-liner. Then re-sew bag as in step 4 above.

4.3.5.2.3 - Bags With Filling Spouts

The filling spout will be located at one side of the top stitching and will pull out to either form a top or side 

spout.

1. Brush and alcohol wipe the area around the spout and carefully pull out spout to reveal the opening. It 

is better to have the bag on its side while pulling the spout, so any dust in the opening falls outside the 

bag.

2. Carefully spread apart the sides of the spout and aseptically draw the sample. A trier or long-handled 

device is usually better for this type of opening because of the limited opening.

3. Carefully close the spout with a firm twisting motion and be sure the opening is closed prior to pushing 

it back into the bag.

4.3.5.3 - Collecting Water Samples

When it is necessary to collect water samples for bacteriological examination, use the following procedures:

1. Use sterile bottles. If de-chlorination of the sample is necessary, you should place sodium thiosulfate, sufficient 

to provide a 100 mg/l concentration, in the clean bottles prior to sterilization. The sodium thiosulfate will 

prevent the chlorine from acting on the bacteria and assures, when the sample is analyzed, that the 

bacterial load is the same as when collected.

2. Carefully inspect the outside of the faucet from which the sample will be drawn. Do not collect the sample 

from a faucet with leaks around handle.

3. Clean and dry the outside of the faucet.

4. Let the water run from the fully open faucet for at least 30 seconds or for 2 or 3 minutes if the faucet is on a 

long service line.
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5. Partially close the faucet to permit the collection of the sample without splashing. Carefully open sample 

bottle to prevent contamination, as in any other aseptic sampling operation. 

6. Fill bottle carefully without splashing and be sure no water from your hands or other objects enters the bottle.

Do not over fill the container. Leave a small air bubble at top.

7. Unless otherwise instructed, the minimum sample size for bacteriological examination is 100 ml.

8. Pack the sample into a clean insulated shipping container with clean ice packs to keep the sample cool while in 

transit. Do not use wet ice to ship the sample to the lab.

9. Deliver the sample to lab promptly. If the sample is not examined within 24 hours after collection, the results 

may be inaccurate.

Note: When documenting specific situations in a plant, you may need to vary this procedure to mimic the actual 

conditions used by the firm.

4.3.5.4 - Sample Handling

Please see the following other sample types and techniques recommended to assure their integrity:

1. For frozen samples, pre-chill sterile containers before use and keep samples frozen with dry ice. Use 

ordinary ice or ice packs for holding and transporting unfrozen samples that require refrigeration. See IOM 

4.7.3.5 and 4.7.3.6. 

2. Under normal circumstances, dried products may be shipped unrefrigerated except in cases where they 

would be exposed to high temperatures, that is, above 37.8oC (100oF).

3. Submit samples subject to rapid spoilage (for example, specimens of foods involved in poisoning cases, 

etc.) by immediate personal delivery to the analyst where feasible.

4. For light-sensitive drug samples, ensure the use of appropriate light-restricting containers.

5. For inflammable material samples (for example, alcohol-based hand sanitizers), use appropriate and 

approved containers, cushioning materials, and safe sample-handling instructions per the FDA Safety

Office. 

4.3.5.5 – Closed Controls 

When collecting any samples using aseptic techniques, submission of unopened, closed controls are required. See 

SOP-001052 (ORA Field Bulletin #30 – Food Program Area – Instruction for Environmental Sampling) for more 

information on environmental samples. Field Guidance documents can be found on the FDA SharePoint site.

For each lot of sterile sampling equipment used to take the sample, submit closed controls identified as one or 

more subsamples (also known as control subs). 

For each lot of sterile sampling equipment used to take the sample, submit closed controls identified as one or 

more subsamples (also known as control subs). 

List control subs on your C/R. Control subs should be identified with a different nomenclature than the physical 

sample, in other words, a, b, c versus 1, 2, 3. Provide control sub lot number(s) and expiration date(s), if applicable.

Examples of various control subs and techniques to be employed are:

1. Sterile Containers: Where sterile containers are used to collect aseptic samples, submit one unopened 

container that was sterilized in the same manner as containers used for sampling. 
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2. Sterile Disposable Gloves: If sterile disposable gloves are used to handle the product, submit one 

unopened pair of gloves as a control.

3. Sterile Swabs/Sponges: When collecting environmental samples with swabs or sponges, submit an 

unopened swab or sponge as a control.

4. Sterile Sampling Equipment: Where pre-sterilized sampling tools are used (for example, scoops, 

containers, swabs, whirl-pak bags, spoons, spatulas, triers, etc.), the closed controls will consist of one 

unopened sampling tool from each lot used. 

4.3.6 – Documenting Filth and Other Contamination 

Documenting the presence of filth or other deleterious material, involves the collection of samples using strategies and 

techniques that represent the product or condition. These samples are selective and generally contain more subs 

(larger) than samples collected for economic or misbranding purposes.

When widespread evidence of filth or other adulteration is present, 402(a)(4) conditions (see Section 402(a)(4) of the 

FD&C Act [21 U.S.C. 342(a)(4)]) are documented through the combination of selective sampling (IOM 4.3.6.3) and field 

examination (IOM 4.3.6.1). 

Documenting filth--such as rodent, insect, or bird contamination--requires thorough examination of numerous lots of 

products to determine the extent of adulteration, along with collecting investigational (INV) samples (IOM 4.1.5) 

inclusive of filth exhibits and photographs supporting the nature and extent of the evidence. Separate filth sub samples 

should be collected from various areas within the firm to illustrate the extent of questionable conditions that led to 

adulteration.

Numerous lots of regulated products should be examined, as you collect official samples of those products 

demonstrating violative conditions. Filth, such as rodent, insect, or bird contamination, observed on the exterior of 

food containers, on pallets containing the product, or on the floor adjacent to the products should be selectively 

sampled and treated as sub samples of the official sample. Documenting potential adulteration of several lots helps 

establish the widespread nature of the adulteration. Compliance Policy Guide (CPG) 580.100 Food Storage and 

Warehousing - Adulteration - Filth (Domestic and Import) can help you determine what to collect for the sample, as 

well as determine minimum criteria for direct reference seizure. (Consult your supervisor when you find evidence that 

meets the criteria set forth in CPG 580.100.) 

When observations indicate that a ready to eat food may be suspectable to microbiological contamination, samples 

may be selectively collected. The samples collected should document manufacturing conditions conducive to 

adulteration. Refer to IOM sections 4.3.6.5 for instruction on selectively collecting microbiological samples. 

When regulatory action appears to be warranted, document recent sales of product from the lot in question. If unsure 

of the significance of your observations, speak with your supervisor for guidance. 

4.3.6.1 - Field Examination to Document Contamination 

A field examination is a physical inspection performed on a product to determine the product’s condition, its 

integrity, or practices used during its storage. The examination includes physically examining several containers 

(cases, cans, bags, units, etc.) of a product. When conducting such exams, take care to describe your observations 

for each container of product examined and all sub samples collected, ensuring to record the violative nature of 

the lot along with any exhibits supporting your observations in your regulatory notes and subsequent C/R 

Collection Remarks, C/R Continuation Sheet FDA Form 464a, or Analyst Worksheet FDA Form 431. Observations 

should be recorded as to accurately and specifically describe the following: general storage conditions, violative 
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condition(s) of the lot, physical relationship of the violative lot to other lots in the area, how you conducted the 

examination, and the number of units you examined. Use quantitative observations, (for example, “insect cast 

skins and 12 live and dead insects were observed on the exterior product bags of a pallet containing 6/50 lb. bags 

of Triticale Meal. The pallet was located approx. 20 feet east of the elevator shaft, adjacent to pillar identified as 

#8 on the floor plan diagram.”).

As in the example notation above, report, if present, the number and location of live and dead insects, rodent 

pellets, or other potential sources of adulteration discovered inside the containers, as well as on their exterior 

surfaces. Provide diagrams and measurements of areas of urine or other bio-chemical stains on each container and 

the extent of penetration. Correlate findings of the examination with photographs and the physical sub samples 

you’ve collected. Providing a floor plan diagram identifying the locations where subsamples were collected helps 

visualize the overall violative condition(s). 

The subsamples collected from obviously violative lots may be reduced to decisively selected exhibits in instances 

in which the field examination is carefully described and documented. The field examination and the report of 

findings will serve as the analysis. 

4.3.6.2 - Random Sampling

When sampling to determine the characteristics of a lot, or the condition of a lot is not known without further 

analysis, samples should be chosen at random. Samples collected at random yield information about the average 

composition of the product lot. Random sampling methodology is used when you have no information or method 

of determining which units are violative. If a violation exists, it will be found by laboratory methodology at a 

specific confidence level, pending the sample size chosen. 

The sample size to be collected is usually described in your assignment. If the assignment doesn’t specify one,

follow the guidance found in the applicable Compliance Program, or the IOM Sample Schedule Charts after the 

Exhibits in this chapter. If no sample size guidance is furnished, discuss an appropriate sample size and 702(b)

portion with your supervisor (see IOM 4.3.2.2 and 4.3.2.3). The general rule is to collect samples from the square 

root of the number of cases or shipping containers in the lot (or available for sampling if lot size is unknown) but 

not less than 12 or more than 36 subs. Subs are collected in duplicate when including a 702(b) portion. If there are 

less than 12 containers, all should be sampled. 

4.3.6.3 - Selective Sampling

When there is widespread evidence of filth or other adulteration present, random sampling methodology is 

undesirable and unnecessary. Under these conditions, examine the lot and select portions of product to sample 

that demonstrate the violative nature of the lot.

When selectively collecting samples, ensure you include exhibits such as diagrams and photographs that 

demonstrate the violative condition, along with identifying the containers of product that were sampled from that 

lot. Exhibit 4-22 contains selective sampling criteria and guidance for sampling for filth, chemical contamination,

and mold contamination.

4.3.6.4 - Abnormal Containers 

See IOM SAMPLE SCHEDULE CHART 2 - Sampling Schedule for Canned and Acidified Foods for listing can defects.
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4.3.6.5 - Microbiological Samples 

During inspections of firms producing products susceptible to microbial contamination (for example, peanut 

butter; dried milk; dairy products; frozen, ready-to-eat seafood; crème-filled goods; breaded items; prepared 

salads; etc.), sampling may be warranted, based on observations or as directed in the Work Plan, Compliance 

Program, or assignment. Follow instructions under IOM 4.3.6.6 when collecting microbiological samples to 

document manufacturing conditions conducive to adulteration.

4.3.6.5.1 – Collection Of Samples For Molds

Mold Samples: During inspections of manufacturers such as canneries, bottling plants, milling operations, etc., 

it may be necessary to collect scrapings or swabs of slime or other material to verify the presence of mold. The 

sample should represent the conditions observed at the time of collection and consist of sufficient material to 

confirm and identify mold growth on the equipment. If possible, take photographs and obtain scrapings, or bits 

of suspect material. Describe the area scraped or swabbed (for example, “material was scraped or swabbed 

from a 2" x 12" area”.)

Suspected filth, collected from ceilings, walls, and equipment, for mold examination must be kept moist by 

placing it in a container filled with a small amount of a 3-4% formalin solution. Large amounts of slime may be 

placed in a wide-mouth glass jar with either a 1% formaldehyde solution, or a 3-4% formalin. Note: Formalin is 

normally sold as a standard stock solution of 37%. To obtain the required 3-4% formalin solution, you’ll need to 

mix 10 ml of the 37% stock solution with 90 ml of distilled water. This will yield the appropriate strength 

solution necessary to “fix” the mold.

Although formaldehyde or formalin are the preservatives of choice, if they’re not available, you may preserve 

the subs in either a 50% alcohol solution or in acetic acid (full strength vinegar).

Special health/safety note: Formaldehyde/formalin is a common sensitizing agent that can trigger an allergic 

reaction in normal tissue after single or repeated exposures. It is also classified as a known human carcinogen 

(cancer-causing substance) by the International Agency for Research on Cancer and as a probable human 

carcinogen by the U.S. Environmental Protection Agency (EPA). Investigators must understand the hazardous 

properties of formaldehyde/formalin so that control measures can be taken to minimize their exposure to it.

The above instructions apply to the collection of raw material, in-line, and finished product samples for mold. 

However, in-line and finished product subs such as doughs, etc., which may be harmed by formaldehyde, may 

be frozen. Check with your laboratory for its recommendation regarding preserving mold samples.

4.3.6.6 – Collection of Environmental and Product Samples for Food Susceptible to 

Contamination with Pathogenic Microorganisms 

Sampling for products susceptible to microbial contamination and the environment in which they are produced 

may help identify the presence of pathogenic microorganisms before they can cause illness. With the recent 

increase in foodborne outbreaks and inspections identifying links between outbreaks and environmental

contamination (including that associated with non-food contact surfaces), there will be an increased focus on 

routine environmental sampling during inspections. Conduct environmental surface sampling as directed by the 

work plan, compliance program or assignment, or based on inspectional observations. If you are unsure of the 

circumstances under which to perform environmental sampling, consult with your supervisor. Also see IOM 5.4.7.2 

for inspectional guidance for firms producing products susceptible to contamination with pathogenic 

microorganisms.
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Collection of environmental and product samples for microbiological testing requires a thorough understanding of 

critical factors associated with the production of the specific product being inspected. In other words, to prove the 

establishment is being operated in an insanitary manner, it is necessary to show the manufacturing operation or 

conditions at the facility that are likely to, or have contributed to, the bacterial load of the product. When feasible, 

inspections should include equipment conditions before a day's production begins as well as the clean-up at the 

end of the day's production. Note that for environmental Salmonella sampling, it is preferable to sample before 

the plant conducts a wet cleaning operation.

Environmental sampling should include sponges or swabs of food contact surfaces (particularly for Listeria 

monocytogenes) and non-food contact surfaces (particularly for Salmonella serotypes), based on observations, or 

as directed. Environmental monitoring supplies should be brought into the firm using precautions to prevent the 

transfer of foreign material into the processing area. 

In-line sampling should be conducted based on observations or as directed. When visible microbial contamination 

is observed, collect finished product as directed in the compliance program or assignment. 

When conducting environmental sampling or product sampling for microbiological testing, whenever applicable, 

an investigator/microbiologist team approach should be used. For environmental sampling, an additional 

employee is recommended to assist with the collection and/or recording of information.

4.3.6.6.1 - Environmental Sampling

CFSAN has developed guidance on the specific locations within a firm to collect environmental samples to 

increase the likelihood of detecting Listeria monocytogenes and Salmonella that may be present. See IOM 

Exhibit 4-20 and 4-21 and SOP-001052 (ORA Field Bulletin #30 – Food Program Area – Instructions for 

Environmental Sampling for guidance on environmental sampling/locations for these microorganisms. In 

addition, please view the training video Environmental Sampling in Food Manufacturing mentioned in SOP001052 (ORA Field Bulletin #30 – Food Program Area – Instructions for Environmental Sampling), which 

provides technical and procedural information on environmental sampling.

In most cases, it is preferable during your discussions with a firm not to mention FDA's intent to collect

environmental samples until, immediately, before sampling begins. Advance notice/pre-announcement of 

environmental swabbing may possibly provide the firm with the opportunity for unscheduled sanitation 

activities. Any such actions by the firm could potentially inhibit microbial recovery and compromise 

environmental sample(s).

During the initial phases of the inspection, the investigator should conduct a walkthrough assessment 

observing and mapping operations, including the location of equipment, flow of the product, foot traffic of 

employees, forklift/mule traffic patterns, segregation of raw material versus finished products, and consider 

sampling areas where food is exposed and being processed, particularly post-treatment/pasteurization.

The “Zone Concept” identifies and prioritizes processing areas from highest risk and closest to the product, to 

lowest risk and farthest from the product, for potential contamination, including harbor growth and “niches” 

for targeted pathogens, and therefore, should be implemented upon conducting environmental sampling as 

follows:

Zone 1: Refers to all direct food contact surfaces, such as slicers, mixers, conveyors, utensils, racks, worktables, 

etc. For inspections focusing on the presence of Salmonellae, such as firms producing peanut products and 

other dry product environments, food contact surfaces are normally not sampled unless specifically requested 
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in the assignment or CP. In contrast, for inspections focusing on detection of Listeria monocytogenes, such as 

firms producing seafood or cheese products in a wet environment, sampling of food contact surfaces is 

essential. 

Zone 2: Encompasses the areas directly adjacent to food contact surfaces (Zone 1). For investigations focusing 

on Salmonellae, this is the area where environmental contamination is most likely to directly affect safety of 

the product. In a small production room, Zone 2 encompasses all non-food contact surfaces in the processing 

area, such as the exterior of equipment, framework, food carts, equipment housing, gears, ventilation, and airhandling equipment, and floors. In a much larger room for example, one that measures20,000 square feet),

Zone 2 is the area in the immediate vicinity of food contact surfaces, such as around the exposed product 

where you could envision a pathway to product contamination either through the actions of people or 

machines.

Zone 3: The area immediately surrounding Zone 2. Zone 3 is an area which, if contaminated with a pathogen, 

could lead to contamination of Zone 2 via actions of people or the movement of machinery. Examples of Zone 

3 areas include: corridors and doorways leading into food production areas or areas in a large production room 

that are further away from food-handling equipment than typical zone 2 areas. Walls, phones, forklifts, and 

“mules”, even if physically located in Zone 2, should be considered part of Zone 3 due to a decreased likelihood 

of cross-contamination. 

Zone 4: The area immediately surrounding Zone 3, generally considered a remote area. Zone 4 is an area 

which, if contaminated with a pathogen, could lead to contamination of Zone 3 via the actions of people or 

machinery. Examples of Zone 4 areas include an employee locker room (if not immediately adjacent to food 

production), rooms, dry goods storage warehouse, finished product warehouse, cafeterias, hallways, and 

loading dock area. 

Every effort should be made to conduct Listeria sampling when the facility has been in production for at least 

four hours and before any wet cleaning is performed. In instances with smaller firms that have short 

production periods, swabbing should be conducted during the mid-to-tail-end of their production schedule.

In most cases, subsamples for Salmonella will be collected from the Zones 2 – 4 (see below), concentrating 

primarily on Zone 2. Samples should be collected from the equipment itself, particularly equipment mounting 

and support structures. When targeting Listeria, swabs will be collected primarily from Zones1 and 2. Perform 

most of the sampling for Listeria in, on, and around food contact equipment, focusing on areas where food is 

exposed and being processed, particularly post-treatment/pasteurization.

A large majority of the environmental samples collected should be taken from Zones 1 (when directed and 

depending on the organism in question) and 2, and, to a lesser degree, Zone 3 areas. Very few, if any, 

environmental samples should be taken from Zone 4 areas.

Swab subsample numbers for each organism are as follows:

For Salmonella environmental swabbing, collect at least 100 swabs/subs and ideally 300 or more subs.

For Listeria environmental swabbing, collect at least 50 swabs/subs and ideally 100 or more subs. 

Document the possible link between the source of an environmental sample and contamination of the food 

product using both written descriptions and photographs. Describe the location of the sample in relation to 

areas where food is exposed and any mechanical or human activities you observe that might cause an 
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organism to be spread beyond this niche environment. The division’s response to a positive swab will depend 

on the proximity of the sample location to the processing line and the likelihood of cross-contamination 

between the swabbed surface and food or food contact surfaces.

On occasion, firms may opt to collect their own swabs in conjunction with your sample. If this occurs, request 

the firm to provide their results when available.

Medical Devices:

Environmental sampling for medical device manufacturers should follow the same strategies outlined above,

as well as any other instructions provided by your supervisor. 

4.3.6.6.2 - Environmental Sampling Equipment and Instructions For Large and Small Area Environmental Surface 

Sampling

These instructions should be followed to ensure standardization of FDA environmental sample technique 

across divisions: 

For environmental sampling, the broth or buffer serves two purposes: 1) to neutralize sanitizer that may be on 

surfaces that you are sampling, and 2) to provide nutritional requirements for the organisms of interest to 

survive the transport to the laboratory. 

Dey-Engley (D/E) neutralizing broth or buffer5 has been shown to be effective as a neutralizing agent against 

the widest range of sanitizing agents that may be in use by a firm and, per ORS, is the one to be used for 

general purpose environmental sampling. 

For large area environmental sampling, handheld sponges or sponges on a stick should be used. The sponges 

on a stick reduce manual contact with the sponge during the sampling procedure and are good for accessing 

tight spaces. Dacron tip swabs are recommended for small area environmental sampling (approximately 10cm 

x10 cm, or 4 x 4 inches). 

Sampling Equipment: 

If sources cannot be located for sponges or swabs pre-hydrated with D/E Neutralizing buffer or broth, use unhydrated sponges and swabs along with single use tubes of D/E neutralizing broth. Do not add additional D/E 

buffer or broth to other types of hydrated sponges and swabs that contain either a neutralizing broth or an

enrichment broth, as this may dilute the concentrations of both components to the extent that they will not be 

effective. 

Handheld sponges or sponges on a stick pre-hydrated with D/E neutralizing broth if available, dry handheld 

sponges or sponge on a stick, swabs pre-hydrated with D/E neutralizing broth, dry swab in swab tube with 

screw on cap or single use tubes of D/E Broth are recommended.

If you need sourcing information for equipment, please contact the Division of Domestic Human and Animal 

Food Operations (DDHAFO) at (301) 796-0360.

Other general sampling supplies you will need for environmental sampling: 

5 The terms broth or buffer are used interchangeably for this product. 
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1. Sterile gloves

2. Hand sanitizers (wash and sanitize hands often during sampling) 

3. Cooling medium for samples 

4. Boxes or coolers 

5. Labels to ID samples 

6. Permanent marker 

7. Flashlight 

8. Sterile metal spatulas (small) or other sterile implement to scrape debris out of cracks 

It is important to use sponges or sponges on a stick for the large majority of samples, since you can sample and 

“scrub” a larger area with a sponge compared to a swab. Swabs are only appropriate for areas that are 

inaccessible to sponges.

Sampling Method: 

For large area environmental sampling, handheld sponges or sponges on a stick should be used. The sponges 

on a stick reduce manual contact with the sponge during the sampling procedure and are good for accessing 

tight spaces. Dacron-tip swabs are recommended for small area environmental sampling (approximately 10cm 

x10cm, or 4 x 4 inches) and for cracks and crevices. 

Gloves:

For collection of environmental samples in Zones 2 –through 4, and for firms targeted as part of routine 

surveillance inspections only, it is not necessary to change gloves between each sub provided that the 

investigator or analyst remains in the same zone and the integrity of the gloves is not compromised during the 

course of collecting the sub, (that is, glove has not ripped, or brushed against a lab coat, etc.) For example, if 

50 swabs are collected in Zone 2, the investigator or analyst would not need to change gloves between each of 

these subs until moving to another zone, or to another distinct processing room or area, unless the condition 

of the gloves warrants changing. Regardless, though, gloves should be sanitized between each sub by applying 

a 70% solution of ethyl alcohol (preferred) or 70% isopropyl alcohol. Note, too, that collection of a large 

number of subs in one area would necessitate several changes of gloves.

For swabs collected in Zone 1 and during “for-cause” inspections (such as those conducted in response to a 

current or previous outbreak, or an emergency), continue to follow the established policy and change gloves

between each sub as described in the Environmental Sampling training video. 

Sampling of Dry Surfaces:

Using a felt-tip black permanent marker, label the sterile bag containing the sponge with appropriate sample

information. 

1. Wash and sanitize your hands to the mid-forearm. Use clean disposable paper towels for drying your 

hands. 
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2. From the outside of the sponge bag, manipulate the handle toward one side. Pull off the top of the 

whirl-pak bag holding the Sponge-stick along the perforation. Using the tabs on both sides of the wired 

band, pull gently to open the bag. Do not remove the Sponge-stick. 

3. Pour into the Sponge-stick bag 9-10 ml or sufficient volume of DE neutralizing broth on the side away

from the handle to hydrate the sponge (do not get broth on the handle). Be careful not to touch the 

opening of the broth container to any non-sterile surface before or during this transfer. 

4. Massage the sponge through the outside of the bag to facilitate absorption. From the outside of the 

bag, push the Sponge-stick to the upper portion of the bag. While pushing the sponge-stick up from 

the bottom of the bag, squeeze excess D/E broth from the sponge back into the bag. The sponge 

should be moist but not dripping wet. 

5. Using aseptic technique, unwrap and place a sterile glove upon the hand you will use for swabbing. Do 

not touch any non-sterile surface (i.e., clothes, skin, counter tops, etc.) with the outside surface of the 

sterile glove. The other hand can be left ungloved for manipulation of non-sterile surfaces and 

materials if preferred. 

6. Remove the Sponge-stick from the bag using your gloved hand. Using even and firm pressure, push the 

sponge in one direction across the desired area of the environmental surface 10 times vertically, then 

10 times horizontally. If visible soil or residue is present, sample the surface by vigorously rubbing the 

sponge over the designated area until the soil or residue is removed. Sampling of large flat surfaces 

(i.e., floor, table tops, and conveyor belts) should cover areas as referenced above, and dependent on 

if the area is unclean, or has been cleaned and sanitized. It may be necessary to wet the sponge with 

additional neutralizing broth when sampling large and/or porous areas. Try to use only enough buffer 

to keep the sponge gliding smoothly over the surface. If there is excess buffer, squeeze it back into the 

whirl pack bag and continue until you have sampled the entire sampling site. 

7. After sampling, return the sponge to the original Whirl-Pak bag with any excess buffer, snap off the 

handle in accordance with the product instructions that accompany the Sponge-stick, and submit as a 

subsample. 

8. Remove the used sterile glove and discard. 

9. Squeeze as much air out of the bag as possible. Roll the top of the bag over several times until it is 

folded all the way down to the sponge. Fold in the tabs to lock the fold in place. Place the sponge bag 

inside another empty Whirl-Pak or equivalent bag and seal as before. Both bags must be tight enough 

to provide both a leak proof seal and minimal airspace during shipment of the moistened sponge. 

10. As soon as possible, place the double-bagged sponge inside an insulated cooler, with pre-frozen gel 

packs to keep the samples cold, but not frozen, and transport/ship the sample to the servicing lab for 

analysis so it is received by the lab within 24 hours of collection. 

Sampling of Wet Surfaces: 

Sample using aseptic techniques with a dry Sponge-stick following the general instructions above for removing 

the Sponge-stick from the bag, and for swabbing. After sampling, return the Sponge-stick to the original sterile 

Sponge-stick bag and using aseptic techniques, add 10 ml of D/E neutralizing broth to the bag. Proceed as 

instructed in #5-10, above. 

Small Area Environmental surface sampling procedure (approximately 10cm x10cm, or 4 x4 inches):
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Swabs are suitable for sampling only very small areas that cannot be accessed any other way. For example, the 

swab can be used to sample the material in a hole in the floor such as might be encountered when a piece of 

floor-mounted equipment has been removed from an area and the bolt hole that remains has not been 

repaired/filled. Swabs may also be useful for sampling floor cracks, or the inside of tubular equipment mounts. 

Sampling of Dry Surfaces: 

Collect samples using aseptic techniques with the swab pre-hydrated with D/E Neutralizing Solution. Using 

even and firm pressure, swab in one direction across the desired surface 10 times vertically, then 10 times 

horizontally, then 10 times diagonally. If visible soil or residue is present, sample the surface by vigorously 

rubbing the swab over the designated area until the soil or residue is removed. Return the swab to its vial, 

place in a Whirl-Pak bag, and as soon as possible, place inside an insulated cooler with pre-frozen gel pack for 

transport/shipment to the laboratory.

Dust and debris scrapings may also be collected using a sterile implement from facilities producing dry 

products, such as nuts and powders. In these cases, a minimum of 5 to 10 grams should be collected with 100 

grams being optimum. When sampling mops or brooms, swabbing with a sterile sponge pre-hydrated with 

D/E Neutralizing solution is an efficient method, although mop strands and broom bristles may also be clipped 

and submitted.

Sampling of Wet Surfaces: 

Collect the sample using aseptic technique using the dry swab in the same manner as noted above. After 

swabbing, still using aseptic technique, add D/E neutralizing solution to the swab and transport to laboratory 

as noted above. 

Collect debris on equipment and from floor defects, joints, and gaps. Debris can be scraped out using a sterile 

implement, such as a small metal spatula. A minimum of 5 to 10 grams should be collected, with 100 grams 

being optimum. 

Closed Controls:

For environmental samples only, collect one closed control for each distinct lot of sterile equipment used and 

submit with the final collection of subs on the last day of sampling.

Open Controls:

Open controls are not to be submitted for environmental sample collections.

Sample Numbering:

Often, multiple days are required to collect an appropriate number of environmental swabs. If an 

environmental surface sample is collected on multiple days during an inspection, use a new sample number for 

each day, (for example., sample no. 100000 on the first day and sample no. 100001 on the second day). The 

subs should be numbered sequentially (for example, subs 1-100 on the first day and subs 101-175 on the 

second day). Link the sample numbers to the assignment for tracking purposes. Environmental swab subs 

should be numerical—that is, 1, 2, 3, etc., while control subs should be alphabetic—that is, a, b, c, etc.
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Product codes have been created to allow for the tracking of environmental samples by commodity; Drugs and 

Foods. When entering data into the FACTS systems for environmental samples, the collector of the sample will 

select the correct “Sample Basis” and enter the correct product code based upon the commodity.

All environmental samples, including swabs, soil, water, and animal scat, are to be identified as Investigational 

(INV). Use the following environmental sampling product codes: 

1. 52Y[][]07 for Farm Environmental Swabs/Samples

2. 52Y[][]08 for Process/Manufacturing Environmental Swabs/Samples 

3. 52Y[][]** for Animal Carcass Rinse/Swabs, where **= 01 (Beef), 02 (Chicken), 03 (Lamb), 04 (Pork), 05 

Turkey), 06 (Other Animal Swabs)

4. 52Y[][]09 for Postharvest Water (for Agriculture use)

5. 52Y[][]10 for Preharvest Water (for Agriculture use)

6. 52Y[][]11 for Spent Sprout Irrigation Water (use for testing)

7. For Drug Environmental Swabs/Samples use product code 66Y[][]07. 

Do NOT use the product code of the covered product for environmental samples. 

4.3.6.6.3 – In-Line Sampling/Factory Food Sample

In-line sampling should be conducted as directed or based on inspectional observations.

Each in-line subsample will consist of approximately 114 g (4 oz), in duplicate (702(b) portion), if that amount is 

available (Also see IOM 4.3.2.2 - 702(b) Requirement). All in-line samples must be collected aseptically. In 

addition, each inline sample should include open and closed controls. The open control should be “opened” 

prior to sample collection, and “closed” when sampling is concluded. The open control should be placed near 

the location where the sample is being collected. The inside of the open control should be exposed only to the 

air in the environment. Do not set open controls, such as gloves, directly onto the floor, or in contact with 

equipment, etc. If different lots of sampling equipment are used (for example, two different lots of gloves are 

used during sampling) then each lot should be represented by both an open and a closed control.

The following are areas vulnerable to microbial growth in which in which you’ll commonly collect in-line 

samples (Note that this is not a comprehensive list since each firm will be different, and sampling will be

dependent processing/packaging techniques, as well as the type of finished product produced):

"Raw" ingredients used in the manufacturing of finished foods (including those conveyed by bulk tankers) 

should be considered for sampling to determine the effect of subsequent processing on bacterial content. Of 

particular concern are raw materials that can support microbial growth, are not normally cooked or prepared 

in a manner that is lethal to pathogenic microorganisms (such as dairy, soy, corn, or sugar syrup-based 

products), and adequate controls to ensure the safety of the finished product are not in effect. Since the major 

portion of some finished food products are not homogeneously contaminated, it may be necessary to collect

multiple subsamples of the raw material(s) to establish a reliable microbial base line.

Obtain sequential subsamples with the view of bracketing each step of the processing operation, in particular 

those steps suspected as routes of product contamination. A series of in-line samples should be collected 

during the first part of a shift, and a duplicate series during the latter part.
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If products or components are heated (for example, blanched, boiled, etc.) take subsamples immediately 

before, and immediately after, heating, before possible insanitary equipment and processing delays contribute 

to bacterial increases. Particular attention should be given to determine routes of cross-contamination from 

the raw product to the "heated" product, especially if this heating step is critical to the destruction of 

pathogenic organisms.

If a product is capable of supporting microbial growth and is not being handled expeditiously, sample before 

and after this particular processing step.

Take time and temperature measurements of cooking, freezing and cooling procedures. Sample when 

appropriate to demonstrate possible microbial growth. Large masses of ingredients may cool or warm slowly 

enough to permit microbial growth.

Improperly cleaned equipment may contaminate the product with bacteria. This may result in either a uniform 

or a spotty increase in bacterial numbers. If possible, scrapings of questionable material should be in sufficient 

quantity to be easily weighed and quantitatively diluted, if collected for analysis.

4.3.6.6.4 - Finished Product Sampling

Collect finished product as directed in the compliance program, assignment, or by your supervisor. Collect 

product from production on the day of the inspection and from the previous day's run. Sampling multiple lots

should be considered, depending on the type of product and process used. The subsamples should consist of 

ten (10) retail size containers, at least 114g (4 oz) each, in duplicate (702(b) portion.

If the finished product is also to be analyzed for Salmonella, collect samples in accordance with instructions in 

the IOM. See Salmonella Sampling Plan, Schedule Chart 1.

For medical devices labeled as sterile, but with suspected or apparent defective packaging, refer to CPG 

300.400 for additional information and consult with your supervisor for additional instructions.

4.3.6.6.5 - Reporting Environmental Sampling Results on the FDA 483

Environmental sampling in ORA's foods program has received heightened focus as of late, as evidenced by 

increasing assignments in the field. To better support consistent policy in this area, criteria for reporting

positive environmental sample results on the FDA 483 has been outlined by the Office of Chief Counsel (OCC) 

and the ACRA. Note the following guidance in support of this policy. This applies to the foods program only.

Significant positive environmental sample results, from swabs collected at food firms, are to be reported on 

the FDA 483 if the results are known prior to the conclusion/closeout of the inspection. However, this does not 

mean you should unnecessarily extend inspections to include the results. The reasoning behind the 

implementation of this policy is that it addresses the following important activities and objectives:

1. Informing the firm of positive results where food products are concerned.

2. Eliciting firm feedback in response to positive results.

3. Providing an opportunity to provide relevant information to both regulators and the public when 

released under FOIA, thereby potentially uncovering, and linking other investigational information that 

can aid in the determination of root contamination cause(s).

4. Fulfilling our responsibility to document positive environment sample results as significant 

observations that can contribute to potentially unsafe conditions posing risks to public health.
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Positive environmental sampling results should be noted on the FDA 483 when the following conditions are 

met:

1. The sampling is related to a current or future foods program inspection/investigation.

2. The inspection has not been closed (Note: it is not requested that the period of inspection be extended 

for the purpose of receiving analysis results).

3. The positive sample finding(s) you uncover represent a significant observation, for instance, you are 

able to clearly demonstrate a route of contamination from the environment to the product by 

establishing positive sample result(s) in Zones 1 and/or 2 for Listeria, or positive sample result(s) in 

Zone 2 and/or 3 for Salmonella.

Note that findings in Zone 3 (Listeria) and Zone 4 (for either pathogen) should not be reported on the FDA 483 

as they normally are not considered significant--except in combination with positive findings in Zones 1 or 2, as

these additional findings would further strengthen regulatory action.

Note regarding medical devices:

Positive environmental sampling results for medical devices may be reported on the FDA 483 with concurrence 

from the Compliance Branch and CDRH.

4.3.6.7 - Samples for Viral Analysis

Sample instructions will be issued by the appropriate center, on a case-by-case basis. 

4.3.7 - Economic Violations 

4.3.7.1 – Net Weight and Volume Determinations 

In cases where you are directed to collect samples for short weight or volume, consult with ORS regarding the 

number and size of subsamples and the servicing laboratory to be used, unless already outlined in an assignment. 

Consult with your management about whether or not a field examination is required during the sample collection.

Exhibit 4-6 is FDA form 485, Field Weight Sheet, and may be used if conducting a field examination.

Instructions for use of the form are on the second page of the exhibit. 

To use the form, weigh 48 units, if that number is available, selected at random from the square root of the 

number of cases in the lot with a minimum of 6 and a maximum of 12. Where units are selected from the 

production line, do so in representative manner. Report the code weighed and if short weight, the quantity in the 

code. Unless otherwise instructed, do not weigh leaking containers. Identify each unit with the corresponding sub 

number on the Field Weight Sheet (FDA 485).

Submit the units indicated by the asterisks on the FDA 485 plus twelve additional weighed units for reserve if the 

average net is below that declared on the label.

4.3.7.2 Economic Labeling 

See FDA’s Industry Resources on the Changes to the Nutrition Facts Label for guidance. See CFSAN’s Office of 

Dietary Supplement Programs and Office of Nutrition and Food Labeling websites as well as FDA.gov for the most 

up-to-date information regarding claims in labeling. (Note: access to ONFL SharePoint site must be requested.)
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Also, see CPGM 7321.005 to determine enforcement priorities for food labeling violations, including those related 

to the Food Allergen Labeling and Consumer Protection Act (FALCPA). 

4.3.8 - Organoleptic Examinations 

Examination of many products may be conducted on the spot without fixed laboratory equipment. These examinations 

vary from simple visual observations for gross filth, such as rodent pellets in wheat, to the detection of odors of 

decomposition in seafood. Organoleptic examinations for regulatory purposes shall be made only by those individuals 

qualified by training or experience to conduct such examinations.

If it is necessary to collect physical subsamples for organoleptic examination and they are collected from bulk, the subs 

must be packed in glass jars to prevent the product from becoming tainted or contaminated by foreign or ambient 

odors.

Review your Compliance Program Guidance Manual and IOM 4.3.6.1 and 6.3.1 for field examination techniques that

may be applicable to specific products or a specific industry.

4.3.8.1 - Whole-Bag Screening 

When making filth examinations by screening shelled peanuts, dried bean, peas, and similar products that are

packed in large containers (for example, in 50-125 lb. bags), use the portable, folding, whole-bag screens available 

in your division.

Conduct the examination in a well-lit area. Set up screen and adjust height to permit opening the bags directly 

onto the high side of the screen. Place another bag or container on the screen's low side to catch the screened 

product.

Place a sheet of clean butcher or similar paper in screen body to catch screenings and insert screen wire over 

paper.

Open stitches of bag being examined to permit approximately ten- to twenty-pound portions to enter onto high 

side of screen. Gradually work the product across the sieve to the low side and into the receiving container. Do not 

push large quantities rapidly across screen because insects, eggs, stones, excreta pellets, etc., will be carried along 

with the product and will not sift through the sieve openings.

Examine the screening from each bag and subjectively report live or dead insects, rodent excreta pellets, or other 

obvious filth. Submit screenings as separate subs if actionable.

4.4 – Documents Collected with Sample 

An official sample is not complete without records documenting its existence in interstate commerce. Additional 

documents may be collected, such as processing records and laboratory procedures used by the dealer.

Follow your division or program procedures for maintaining hardcopy and/or electronic records covered in this section.

See 4.6.4 – Routing.

4.4.1 – General Considerations/Procedures regarding Documents 

Ensure the copies of records obtained pertain specifically to the sample collected. If copies of certain records are 

unavailable (for example, shipping records are no longer available at the site or have been destroyed due to age), you 
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should add statements documenting the circumstances on the affidavit and, if possible, document where these 

records could still be obtained and from whom.

Do not remove the dealer's only copy of records. Whenever possible, scan, photograph, or photocopy it. 

Reproductions must be reviewed to ensure all relevant information is readable and to verify the copy you receive is an 

accurate representation of the original record. 

Digital tools may also be used to enhance the contrast of documents scanned or photocopied to make them more 

readable. Whenever enhancement is applied to a document using any method, document the steps taken in your 

notes and the corresponding collection report.

In cases where the finished product being sampled is not shipped to interstate customers, but is formulated from raw 

materials with interstate origin, jurisdiction may be established by documenting the interstate shipment of one or 

more major raw materials. (This would be a 301(k) sample. See IOM 4.1.4.2.2.) An affidavit from a knowledgeable and 

responsible firm official may be used to link copies of records showing interstate movement of the raw material with 

copies of records showing subsequent use in the lot being sampled; if documentation of the use in production is not 

available or clear, statements on an affidavit may be collected to support the linkage. 

4.4.2 – Identifying Sample Records 

Identify copies of all records obtained (except copies of FDA forms) and attach to the collection report labeled with the 

sample number (including the prefix if appropriate), collection date, and collector’s name or initials (the investigator

who completes the collection report is the collector, See IOM 4.6.2.10). If more than one document (other than FDA 

forms) is to be attached to the collection report, include a sequential document number as part of the document label 

which will be used to refer to the document in the list of documents as part of the collection report in FACTS; copies of 

FDA forms may be assigned a sequential document number for identification in the collection report, but should not 

be labeled or altered from their original form. If a document (other than FDA forms) is more than one page in length, it 

should be numbered to allow reviewers to determine if any pages are missing. See IOM 5.11.4.3.20. 

Here is an example of this labeling, where it is applied to the second page of the third document attached to a 

collection report:

“DOC117883

7/12/2022

ENH

Document 3, Page 2 of 12”

If the firm maintains their records electronically, see IOM 5.3.8.3.3, 5.3.8.3.1 and 5.3.8.3.2.

4.4.3 - Evidence Required 

When documenting known violative situations with a sample and its related records, you need to consider whether 

you have established FDA's jurisdiction, documented the interstate commerce, shown a violation, and determined 

responsibility for the violation (JIVR). See IOM 2.3.1.
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When the violative nature of a sample is not known at the time of collection--for example, when laboratory analysis is 

necessary to determine the adulteration of a product regulated by the FDA--collection of available documentation to 

support a potentially violative situation should be considered. Consult with your supervisor for guidance. 

4.4.3.1 – General Considerations for Evidence 

When you are collecting evidence, including samples, to demonstrate a violation(s), it is important to understand 

the specific charges that may be made and the anticipated action the agency may take. Most charges would be 

made against the product or a person and are prohibited acts that can be found in Section 301 of the FD&C Act [21 

U.S.C. 331]. Additional information and guidance on the evidence required to support certain judicial actions is 

available in the Regulatory Procedures Manual, Chapter 6. 

Note that throughout this section, the term dealer is used with the same meaning as outlined in subsection 4.1.3.1 

of this chapter; essentially, the dealer means the person who has possession of the FDA-regulated product at the 

time it is been collected, regardless of the firm’s operations. A dealer may be a manufacturer, warehouse, or other 

operator.

Below are the most common prohibited acts encountered by investigators and the kinds of evidence you may 

collect to demonstrate such violations. Since each case is different, you must consider carefully if you have 

collected the appropriate evidence to show the violations that may be charged. You should also keep in mind that 

more than one prohibited act may be applicable to a product, or person, and so you should be prepared to 

document multiple violations related to the same product, or document multiple instances of the same prohibited 

act that occurred related to multiple products. 

You should also consider the appropriate action the division will be taking. If the division would be considering an 

injunction, for instance, it is important to demonstrate that the violative action is ongoing and that collecting 

recent evidence to demonstrate that multiple lots of product/s were violative will support such an action. For a 

seizure action, you will need to consider if the division will pursue a single lot seizure or a mass seizure of products. 

Evidence required for a mass seizure needs to show an ongoing, widespread, uncorrected condition that causes all 

products the dealer holds at a location to be violative. Be sure to discuss the appropriate action with your 

supervisor who will likely want to confer with compliance branch and the center. However, do not let delays 

conferring with others delay your collection of evidence. (See 4.4.3.2)

4.4.3.1.1 - Introduction into Interstate Commerce (FD&C Act 301(a) and 301(d) charges) 

If the dealer is shipping adulterated or misbranded product, collect evidence showing the dealer distributed 

the product in interstate commerce. You should obtain evidence showing the date of shipment and the 

specific shipping information of the product. Your evidence must show shipment to another state or territory

of the product in question. 

This prohibited act also includes “delivery for introduction into interstate commerce.” If you cannot obtain 

evidence showing shipment in interstate commerce, then you need to show that the dealer had knowledge 

that the person they were distributing it to intended to introduce the article into interstate commerce. See 

Section 301(a) or (d) of the FD&C Act [21 U.S.C. 331(a) or (d)]. 

4.4.3.1.2 - Adulteration or Misbranding in Interstate Commerce (FD&C Act 301(b) charges) 

Collect evidence showing that the specific product in question was in interstate commerce at the time that it 

was rendered violative. See Section 301(b) of the FD&C Act [21 U.S.C. 331(b)]. If you are documenting a 

shipper violation at a dealer, it is your responsibility to show the storage conditions at the dealer did not 
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contribute to the violation. Obtain an affidavit describing handling of the goods after receipt, and any other 

information that supports the violation. An example of this could be a refrigerated or frozen product that was 

shipped without proper refrigeration and “spoiled” before receipt at the dealer. Keep in mind when 

documenting this violation at a dealer who received the product, that there is also the violation found in 

section 4.4.3.1.3. Either or both charges may be made, and both should likely be documented.

4.4.3.1.3 - Receipt in Interstate Commerce (FD&C Act 301(c) charges) 

If the dealer knowingly receives adulterated or misbranded product, collect evidence showing receipt of 

violative product in interstate commerce. The documentation collected may be the same as that collected in 

section 4.4.3.1.2. In general, when making this charge, you should demonstrate that the dealer was aware of 

the violative condition of the product before the delivery or accepted the delivery knowing the product was 

violative. Whether it was sold or given away is immaterial. See Section 301(c) of the FD&C Act [21 U.S.C. 331 

(c)]. 

If the dealer causes the adulteration or misbranding of an FDA-regulated product, it is a 301(k) violation. See 

4.4.3.1.6 below. 

4.4.3.1.4 - Manufacture Within a Territory (FD&C Act 301(g) charges) 

Under this prohibited act, the product does not need to be shipped in interstate commerce. The mere act of 

manufacturing a violative product in a territory (as defined in Section 201(a) of the FD&C Act [21 U.S.C.

321(a)(2)) is prohibited. Collect evidence revealing that the product was manufactured within any territory. 

Note that the term territory does not include the Commonwealth of Puerto Rico. See Section 301(g) of the 

FD&C Act [21 U.S.C. 331(g)]. 

4.4.3.1.5 - False Guaranty (FD&C Act 301(h) charges) 

A guaranty typically involves a statement that the product being sold to the dealer in in compliance with the 

FD&C Act or FDA regulations. In addition to evidence showing the guaranty is false (for example, the product 

was adulterated when received) obtain copies of the specific guaranty. Also collect any shipping records

associated with the violative product. Each guaranty usually covers a specific sale (and delivery) on or about a 

definite date to the holder of the guaranty. Although interstate commerce is not required, you should obtain 

evidence demonstrating that the consignee normally engages in some kind of interstate business. See Section 

301(h) of the FD&C Act [21 U.S.C. 331(h)] and 21 CFR 7.13, 201.150 and 701.9. 

4.4.3.1.6 - Dealer Violation (FD&C Act 301(k) charges) 

For this prohibited act, you must collect records showing the dealer received the product in interstate

commerce and that the product was made violative by the dealer. One example of this is adulteration of 

product in a filthy warehouse where there is rodent activity and there is evidence that the product is being 

adulterated with filth by the rodents (for example, a rodent infestation). Another example is where a drug 

manufacturer receives an unadulterated active pharmaceutical ingredient and by failing to follow GMPs 

manufactures a violative product. In both cases, collect evidence of interstate origin of the article (in our 

examples, the product found adulterated by rodents or the active pharmaceutical ingredient) and proof of a 

specific action which adulterates or misbrands the article (for example, evidence of rodent activity or failure to 

follow GMPs). See Section 301(k) of the FD&C Act [21 U.S.C. 331(k)] and IOM 4.1.4.2.2.
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4.4.3.2 – Evidence for Seizure, Injunction or Criminal Prosecution 

For a seizure action (see IOM 2.8.3), the FDA must fulfill the following: establish jurisdiction over the product, show 

its interstate movement, and document a violation. However, it is not necessary to establish responsibility for the 

violation.

You should obtain copies of all available records that show the article was introduced into or in interstate

commerce or held for sale after shipment in interstate commerce. Additional information on the requirements for 

seizure actions can be found in the RPM, Chapter 6-1. See also 21 U.S.C. 334 (FD&C Act 304) - Seizure. 

For an injunction (see IOM 2.8.4) or criminal prosecution (see IOM 2.8.5), the proof required depends on the 

violations of the law. Information on the specific requirements for these actions can be found in the RPM, Chapter 

6-2 and 6-5. See also 21 U.S.C. 331 (FD&C Act 301) - Prohibited Acts.

4.4.3.3 - Complaint or Injury Samples 

Generally, samples collected from complainants during investigation of injuries or foodborne out-breaks are investigational in nature and significant documentation of interstate commerce is not collected. However, if the nature 

of the contamination or adulteration is such that regulatory action may be warranted, the interstate nature of the 

sample should be well documented. Affidavits from the consumer, retailer, and wholesaler should be obtained as 

applicable.

At times, even though you may not be able to obtain physical portions of the involved item, a Documentary

Sample can be collected by photographing the container, contents, labels, codes, etc., and by obtaining necessary 

affidavits and interstate records. See IOM 8.1.5 for additional instructions on tampering, counterfeit, and other 

complaint samples.

4.4.4 - Documenting Interstate Shipments 

The minimum set of records ordinarily submitted with an official sample will consist of a copy of the invoice covering 

the sale of the lot, batch, or unit to the dealer; the transportation record showing interstate commerce; and an 

affidavit signed by the dealer that identifies both the lot, batch, or unit sampled and the applicable records. See IOM 

4.4.2.

Documentation obtained at a location other than the dealer where the sample was collected should be the subject of a 

memorandum to accompany the collection report. 

Note: In the case of imported products that have been released to domestic commerce, documentation of the sample

should also include the port of entry and the importer of record, if possible, to facilitate investigation by the home 

division if necessary.

4.4.4.1 - Sales Records 

An invoice does not establish interstate commerce and thus federal jurisdiction. It does not prove actual 

movement of an FDA-regulated product. However, it may provide information as to the value of the goods, the 

carrier, date of shipment, etc., and bear a Food and Drug type guarantee. Collect copies of the invoice to show the 

owner's intent to sell the product and tie other records to the sample. If the invoice covers numerous items, be 

clear on which lines correspond to the sampled products and identify those in the collection report. Other records 

which may be collected in addition to an invoice to show product sales are: copies of purchase orders, receiving 
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records, canceled checks, correspondence, etc. If no invoice is available for a sample, one or more of these should 

be collected and included in the collection report.

In addition, invoices often show details about the contents of a shipment and its value, and a Bill of Lading (BOL) 

may not. For example, a BOL may indicate one pallet of canned food, but the invoice will declare that the 

purchaser paid for “50 cases of 6 containers each of #10 cans of green beans” and include the cost per container. 

Tying the Invoice and BOL together shows exactly what product was shipped in interstate commerce under the 

BOL. The BOL often refers to an invoice # and vice versa as well. The affidavit is critical to tie the two together. 

Invoices covering in-transit shipments usually are not available. For these samples, document any available 

transportation record that establishes the lot to be in interstate commerce. Be sure to name the shipper and 

consignee if known. Where positive identification of a shipment cannot be made by personal observation, obtain a 

statement from the carrier's agent identifying the shipment sampled as having been delivered by the consignor on 

a certain day for delivery to the consignee. Include in this statement reference to the specific transportation record 

covering the shipment. The transportation record will generally be available after the shipment is delivered.

4.4.4.2 - Transportation Records for Common Carrier Shipments 

Section 703 of the FD&C Act [21 U.S.C. 373] provides for mandatory access to and copying of all records showing 

interstate movement of commodities subject to the Act. This is provided the request is in writing, and the records 

are in the possession of common carriers, or persons receiving or holding such commodities.

Section 704(a) of the FD&C Act [21 U.S.C. 374(a)] provides mandatory access, upon presenting your credentials and 

issuing a written notice of inspection, to documents covering the interstate movement of non-prescription drugs 

for human use, prescription drugs, and restricted devices. The authority applies to inspection of any factory, 

warehouse, establishment, or consulting laboratory in which prescription drugs, nonprescription drugs for human 

use, or restricted devices are manufactured, processed, packed, or held.

Note: At times, you may have only the name of the carrier (trucking company), with no address or phone number. 

If you are unable to locate the trucking company, contact the local office of the U.S. Department of Transportation 

(DOT) Federal Motor Carrier Safety Administration (FMCSA). Local contact information can be found at the FMCSA 

field office contact information website. 

4.4.4.2.1 - Refusal To Permit Access To Records In Possession Of Common Carriers 

Refusal to permit access to and copying of all records showing interstate movement of articles subject to FDA 

jurisdiction is unlawful provided the request for such permission is issued in writing. You cannot state that the 

law requires the records be furnished to FDA unless you also explain that it is required only after a written 

request is issued. If refused, after providing a written request as outlined below, politely explain that the law 

requires the records to be furnished. You are more likely to get the records through courteous persuasion and 

tact than through stressing the force of law.

4.4.4.2.2 - Written Request For Records 

If a carrier, consignee, or any other person refuses to supply I.S. records, and it is apparent they will not do so 

without a written request, report the facts to your supervisor. Do not routinely issue a written request for I.S. 

records since evidence so obtained may not be used in the criminal prosecution of the person from whom it 

was obtained.
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If the request is being made of a carrier who has no responsibility for the violation, issue a written request only 

after approval by Division Management. When authorized by your supervisor to issue a written request, 

prepare a statement, using the following guidance, or as otherwise directed by your supervisor:

"Pursuant to Section 703 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 373) permission is hereby 

requested for access to and copying of all records showing quantity, shipper, and consignee, showing 

movement in interstate commerce and/ or the holding after interstate movement of___________."

Clearly identify the specific lots that are the subject of the request, the firm, and the individual to whom the 

request is given.

4.4.4.2.3 - Bill of Lading 

The shipper who delivers the goods to the carrier for shipment, prepares the bill of lading (BOL), which is an 

order for the carrier to move the goods. When the carrier's agent signs the BOL, they acknowledge receipt for 

the shipment. The carrier's office in city of origin of shipment maintains a copy of the BOL. Information 

normally included on the BOL is the name and address of shipper, name and address of consignee, date of 

shipment, name of carrier, vehicle number, and a description of the goods. 

4.4.4.2.4 - Freight Bill 

This record is prepared by the transportation company for the purpose of collecting freight charges. It includes 

the same information found on the BOL, plus additional data about the carrier's handling of the shipment and 

costs involved. Railroads prepare freight bills at their destination offices, where copies can be made. 

Waterborne vessels and aircrafts may combine the BOL and freight bill into one form. Copies are filed at both 

origin and destination offices of these carriers. Truck lines prepare freight bills at the origin office, and both 

origin and destination offices should have copies. The dealer should have a freight bill if they received the 

goods directly in interstate commerce.

4.4.4.2.5 – Waybill 

The transportation company uses the waybill in its own operations, and it accompanies the shipment during 

transit. Copies are not generally given to the shipper or consignee but can be obtained from the carrier. Other 

transportation records are generally more readily available than waybills. Air freight waybill numbers are 

designed so that the originating line and point of origin are encoded in the waybill number itself. Each airline 

has a numerical code description, indicated by the first two digits of the number. The three letters, which next 

follow indicate the point of origin. For example, Waybill No. 01LGA, designates American Airlines (01) as the 

carrier, and La Guardia Field (LGA) as the point of origin. Most airline offices have a copy of "Official Air Freight 

Transmittal Manual," which lists the codes. Other express shipping companies/parcel services, such as Federal 

Express and United Parcel Service, may establish their own codes for air freight waybills. Air freight waybills 

may be referred to as air bills, airway bill or air waybills, depending on the company/service.

4.4.4.3 - Mail or Parcel Service Shipments 

Record the facts obtained from the dealer on the FDA 463a, Affidavit, or FDA 463, Affidavit (Parcel Post/Service). 

See IOM Exhibit 4-9. 

Collect shipping documents, including the shipping label, shipping details, and proof of delivery of the shipment. To 

obtain documentation for USPS shipments, ask the dealer where the sample is being collected, and ask the dealer 

to use the shipment label reference number to print the shipping documents from https://www.usps.com. If the 
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article was shipped with Express Mail®, point-by-point tracking details are available. To obtain documentation for 

parcel service (for example, UPS and Fed Ex shipments, ask the dealer to use the “tracking number” to print the 

shipping documents from the parcel service’s website. Always attempt to collect copies of the original wrappings 

showing cancellation of origin office and address sticker if the dealer is the recipient of the shipment, since the 

recipient will usually not be able to print the shipping label. Wherever possible, collect an affidavit to link the 

carrier’s (for example, UPS, FedEx, etc.) tracking number document to the actual shipment and delivery 

documentation and attach to the collection report. 

If the shipment is not recent, the dealers may not have access to the records through their accounts. In this case, a 

visit must be made to a major parcel service/ parcel post office to obtain the documentation.

4.4.4.4 - Shipment by Privately-Owned Conveyance 

Obtain on the FDA 463a, Affidavit, a dealer's statement setting forth the facts, including the date and manner of 

receipt. The affidavit by the dealer may not be evidence, since the dealer lacks personal knowledge of the point of 

origin. If possible, ascertain the name and home address of the driver of the conveyance, vehicle license number, 

the name and address of the driver's employer, or the owner of the conveyance and the driver's license number. 

Obtain an Affidavit, from the driver setting forth the facts of the shipment. See IOM Exhibit 4-10.

4.4.4.5 - Form FDA 1662, Copy of Invoice/Shipping Record 

A Form FDA 1662 can be used to record invoice and/or shipping record information--see Exhibit 4-8. Invoice 

information can be entered in Section I, Copy of Invoice. For invoice information, record entries covering items 

sampled and indicate omissions by asterisks. If the invoice bears a Food and Drug guarantee, copy the guarantee 

on the back of the FDA 1662. Bill of Lading or Freight Bill information can be entered in Section II, Copy of Shipping 

Record. Enter the type of shipping record in Block 21. If only one section is used, leave the other section blank and 

submit the entire form.

4.4.5 – Affidavits 

Statements on various affidavit forms may be obtained from individuals who have in some way dealt with the goods 

sampled, know material facts relating to the movement of the goods, and/or to events affecting their condition. Such 

facts, recorded in writing and signed by the individual who can testify in court to those facts, can be used either to 

establish federal jurisdiction or the responsibility for a violation. The statement may cover the following items: identify 

documents proving I.S. movement of goods sampled, name the individual who can testify to the identity of the goods 

sampled, and certify that the sample collected is from the lot of goods covered by the records. While these statements 

may be obtained from firm management, when possible, it may be necessary to obtain affidavits from other 

knowledgeable individuals if management is not personally aware of, and cannot testify to, such matters. See IOM 

4.5.1 for additional requirements for Bioresearch Monitoring affidavits.

4.4.5.1 - General Considerations for all Affidavits 

You should have the affiant read the statement and make necessary corrections before signing the affidavit. 

Mistakes, corrected and initialed by the affiant, are an indication that they have read and understood the 

statement. A handwritten statement on the affidavit by the affiant, declaring that they have read and understood 

the statement, is a valuable tool to counter the possibility the affiant might later claim ignorance of what was 

signed.
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During investigations of alleged tampering incidents, complainants must be advised of the provisions of the 

Federal Anti-Tampering Act (FATA). A general discussion of the FATA, its provisions for investigation, filing of false 

reports, and tampering can be useful and informative to those individuals. See IOM 8.1.5.9.9

Before the individual signs the statement, ask them to affirm that the affidavit is true and accurate. A statement to 

that effect can also be added at the conclusion of the affidavit. See IOM Exhibit 4-11.

You should only sign the affidavit in the presence of and immediately after the affiant has signed it. As the wording 

on an affidavit above your signature reads, "Subscribed and sworn to before me at ***," with “subscribed,” in this 

context, meaning to attest by signing--your signature is attesting to the fact that the affiant has read and 

understood the statement and has confirmed that the statement is the truth. You MUST NOT sign an affidavit until 

after the affiant swears (affirms) to you the written statement that they have signed is true. You and the affiant 

should sign all pages of a multi-page affidavit. If you provide a copy of the affidavit to the affiant, it must be a copy and 

not the original, which now serves as an official FDA document.

If the affiant requests to have legal counsel review the document before they are willing to sign, and such review 

would not significantly delay the course of the sample collection or other activity, the affiant may make a copy of 

the unsigned document and provide it to their counsel. If the review will significantly delay the course of the 

sample collection or other activity, attempt to reach a mutually agreeable resolution with the affiant. If none can 

be reached, document the matter as a refusal to sign the affidavit. See section 4.4.5.3. 

If the affidavit is signed, offer to provide a copy of the signed document to the affiant. Retain the original signed 

document for submission with the collection report. If a refusal is encountered to sign the affidavit, see 

instructions just below in section 4.4.5.3. 

4.4.5.2 – Affidavits for Non-English or Limited English Proficiency Speakers 

In cases where the affiant does not speak English, prepare the affidavit on form FDA 463a in the affiant’s native 

language. If necessary, enlist the assistance of a translator. Having a qualified translator present is necessary to 

explain the statement and assist in discussion. The affiant will only sign the version in their native language—even 

though a translated English version will also be prepared--as that would be the one the affiant can attest to. After 

the affiant signs the affidavit that was written in their native language, you will then sign the native language 

version as the affiant has sworn this statement to you.

As noted, a second affidavit should be created to translate the statement into English, with the translator as the 

affiant. This affidavit includes the translator’s qualifications and the English translation of the statement. The 

translator will swear the translation of the native language affidavit is accurate. After the translator signs the 

second affidavit, the FDA employee will sign it. Note that the translator and witness to the second affidavit cannot 

be the same individual. The translator's signature is to be placed following the written English translation and their 

credentials written in the narrative section of the affidavit. The second affidavit should be appended to the 

original.

If the affiant requests to have legal counsel review the document before they are willing to sign, and such review 

would not significantly delay the course of the sample collection or other activity, the affiant may make a copy of 

the unsigned document and provide it to their counsel. If the review will significantly delay the course of the 

sample collection or other activity, attempt to reach a mutually agreeable resolution with the affiant. If none can 

be reached, document the matter as a refusal to sign the affidavit. See section 4.4.5.3. 
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If the affidavit is signed, offer to provide a copy of the signed document to the affiant. Retain the original signed 

document for submission with the collection report. 

4.4.5.3 - Refusal to Sign the Affidavit 

Prepare the statement as described above even if it is apparent the affiant will refuse to sign the affidavit. Have 

the affiant read the affidavit. If they decline, read it to them. Request the affiant correct and initial any errors in 

their own handwriting. Ask the affiant if the statement is true and correct. Ask them to write at the bottom of the 

statement: "I have read this statement and it is true, but I am not signing it because..." in their own handwriting.

If the affiant still does not sign the affidavit, you should write a statement noting the refusal situation. Write this 

near the bottom and within the body of the affidavit; it is only necessary to include this statement on the last page 

of the document. Detail the actions taken by both parties, such as: “I recorded the above facts as the affiant 

revealed them. The affiant then read the statement and avowed it to be true.” Or, in contrast: “The affiant refused 

to read and sign the statement and stated their reason for refusing to sign was ‘upon advice of corporate 

counsel.’” (An affiant might also refuse, claiming “corporate policy,” or something similar, among other reasons).

Sign and date this statement in the body of the document; only sign in the signature block if the affiant signs the 

affidavit. Once the refusal is documented on the affidavit, it is not necessary to include any additional narrative 

under the “Refusals” heading of the EIR.

After the refusal has been documented, and if the affiant requests a copy of the unsigned affidavit, inform them 

that copies of refused affidavits are not routinely provided to firms, but may be requested under FOIA.

4.4.5.4 - Confidential Informants 

You should take special precautions when obtaining an affidavit from a confidential informant. The affiant may be 

reluctant to sign a statement that reveals their identity. See IOM 5.2.9 for guidance on interviewing confidential 

informants.

4.4.5.5 - Affidavit (Dealer/Warehouseman FDA 1664) 

The Affidavit (Dealer/Warehouseman), FDA 1664, is used to document the dealer or warehouseman identification 

of the lot and related records. See IOM Exhibit 4-12.

Fill in all blanks on the form as applicable. There are sufficient blanks for listing up to three invoices, and up to 

three shipping records covering the lot in question. Any unused blanks should be lined out. You should also strike 

out the words or letters in parentheses that are not applicable.

Be certain that the dealer knows what they are signing. Before the individual signs the statement, they should be 

asked to affirm the affidavit is true and accurate.

4.4.5.6 - Affidavit (FDA 463a) 

Unusual sampling situations may present circumstances that do not lend themselves to presentation on the FDA 

1664 or 1664b. In these situations, record the facts on an FDA 463a, Affidavit.

There is no prescribed format for composing the statement, however, you should positively identify the affiant by 

name, title, and address at the beginning of the statement and show why they are qualified to make the 

statement. The facts can be arranged in an order roughly paralleling that of the FDA 1664. In general, a narrative 

that describes the events and circumstances chronologically is most manageable. Whatever format is used, the 
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recorded facts must be intelligible to the reader unfamiliar with the transaction. See IOM Exhibit 4-7, 4-10, 4-11, 4-

13 and 4-14.

Ascertain all the facts and record those that are material, relevant, and to which the affiant can affirm.

Narrate the facts in the words of the affiant, using the first-person singular. Do not use stilted terms such as, "that" 

as in the expression "that I am the president of..." If the statement is long and complex, break it down into logical 

paragraphs.

Have the affiant read the statement and make necessary corrections before signing the affidavit. Mistakes that 

have been corrected and initialed by the affiant are an indication that they have read and understood the 

statement. A handwritten statement by the affiant declaring that they have read and understood the statement is 

a tool to counter the possibility the affiant might later claim ignorance of what was signed.

Before the individual signs the statement, they should be asked to affirm the affidavit is true and accurate. A 

statement to that effect can also be added at the conclusion of the affidavit. Only sign in the signature block if the 

affiant signs the affidavit. See IOM Exhibit 4-11.

4.4.5.7 - Affidavit (Jobber FDA 1664a) 

Form FDA 1664a is used to document movement of goods from a jobber to a dealer. See IOM Exhibit 4-14. 

Complete all blanks as applicable. There are sufficient blanks to list up to three invoices and three shipping records. 

Line out any unused blanks and strike out all words and letters in parentheses that are not applicable.

Be sure the jobber knows what they are signing. Before the individual signs, they should be asked to affirm that the 

affidavit is true and accurate. A statement to that effect can also be added at the conclusion of the affidavit. Only 

sign in the signature block if the affiant signs the affidavit. See IOM Exhibit 4-11.

4.4.5.8 – Affidavit (Parcel Post/Service FDA 463) 

Always attempt to collect copies of the original wrappings showing cancellation of origin office and address sticker. 

In uncomplicated situations, the FDA 463, Affidavit (Parcel Post/Service) may be used. See IOM Exhibit 4-9. Before 

the individual signs the statement, he should be asked to affirm that the affidavit is true and accurate. A statement 

to that effect can also be added at the conclusion of the affidavit.

4.4.5.9 – Affidavit (In-Transit Sampling FDA 1664b) 

See IOM 4.1.4.2.1 and 4.3.3.3 for definition and sampling procedures. When obtaining samples from in-transit lots, 

if it is a straightforward uncomplicated sample requiring no unusual explanations, the FDA 1664b, Affidavit (InTransit Sampling) may be used. See IOM Exhibit 4-3. Otherwise, use the regular Affidavit, FDA 463a.

4.4.6 – Documenting Sample Manufacturing 

During collection of a sample at a manufacturer or similar entity, collection of available manufacturing records may be 

warranted to help establish interstate commerce, document manufacturing issues, or for other reasons depending on 

the reason for sampling.

The records you collect should generally show the receipt of a component, part, or ingredient after shipment in 

interstate commerce; the use of that component, part or ingredient in the finished product that is being sampled, the 

acceptance and release of the finished product for shipment/delivery; and, where applicable, documentation of 
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potentially significant deficiencies in those activities which may render the product adulterated or misbranded

(301(k)). If documentation is not present in one or more of these areas, an affidavit from a knowledgeable individual 

may be collected in conjunction with other documentation to establish the manufacturing of the products being 

sampled. 

When collection of manufacturing records is indicated, consider collecting the following types of records to support 

your sample: 

1. Receiving Records - Some firms may maintain a receiving log, receiving record, or an entry in an electronic 

system to indicate receipt of the components, parts, or ingredients used in production of an FDA-regulated 

product. Obtain documentation showing the receipt of at least one component, part, or ingredient used in the 

production of the finished lot, batch, or unit being sampled--such as a component that has moved previously in 

interstate commerce. 

2. Manufacturing records – Depending on the firm and the commodity, records showing the manufacture of 

finished products may vary, including documents referred to as batch records, device history records, etc. 

Obtain documentation showing the incorporation of the component, part, or ingredient above, into the 

finished product lot, batch, or unit being sampled.

3. Acceptance records – Depending on the firm and the commodity, records showing the responsible individual(s) 

who accepted and released the products for distribution may be present on a form, in an electronic system, in 

an email, or documented in some other manner. Obtain the documentation showing the authorization for 

release of the lot, batch, or unit being sampled.

4. Manufacturing deficiencies – When samples are collected, particularly as part of an inspection, one or more 

potential deficiencies may be observed in the manufacturing process that could result in the products being 

adulterated or misbranded. Where this is known at time of sampling, obtain documentation supporting these 

potential deficiencies.

4.4.7 - Labels And Labeling 

All samples collected must include copies of the product label and any other labeling associated with the product 

collected, unless the sample collected is unlabeled (for example, as with inline samples and INV samples). 

Refer to Section 201 of the FD&C Act [21 U.S.C. 321] for the definition of label (201(k)) and labeling (201(m)). 

Labels and labeling are critical to establishing FDA’s jurisdiction over a food, drug, device, tobacco product, or 

cosmetic. In addition, labels/labeling are important for other reasons, such as determining which regulatory provisions 

and/or prohibited acts may apply to the product. 

No special effort is needed to obtain copies of a label when it is affixed to the individual units collected. However, you 

should note that goods may be accompanied by labeling that is not affixed to the product, and in these instances, will 

need to obtain clear and complete copies of that additional/accessory labeling. You can obtain a copy of the original 

labeling by requesting an exact duplicate copy of the original from the dealer, or through photographing, scanning or 

photocopying the original labeling. Even though your sample assignment may not specifically request the collection of 

accompanying labeling, you should still determine if such labeling exists--and if it is present--collect it.

Unless directed otherwise by your compliance program (CP) or assignment, collecting one clear and complete copy of 

original labels and labeling is sufficient. Scan or photograph the labels and labeling digitally so that they can be readily 

reviewed by various individuals located in separate offices. Do not collect the actual label or labeling if only one copy is 

available as this may inadvertently correct any misbranding that may be present or introduce misbranding via the 
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removal of legally mandated information. Instead, if this is the case, take photographs or other copies of the single, 

actual label as described above. Furthermore, do not collect a print proof or any type of prototype as your copy of the 

original product label or labeling. 

When documenting labeling violations, refer to the relevant Compliance Program or discuss with your supervisor if 

more than one original copy is required. Another means to achieve this is that a sample of product may be collected 

and its label stripped in order to obtain original labels.

4.4.7.1 – Definition: Labels and Accompanying Labeling 

A label is a display of written, printed, or graphic matter appearing upon the immediate container of an article.

Labeling includes all labels and other written, printed, or graphic matter appearing upon any article, or any of its 

containers or wrappers, or accompanying (not necessarily affixed to) such article. Labeling includes such materials

as--circulars, booklets, placards, displays, window streamers, books, article reprints, websites, 

instructions/directions for use, manuals, technical bulletins, etc.--that supplement or explain a product and/or are 

part of an integrated distribution system for the product. 

4.4.7.2 – Collection: Labels and Accompanying Labeling 

When collecting physical copies of labels/labeling, request that the dealer identify collected copies of 

accompanying labeling with their initials and the date (Note: a manufacturer may be considered a dealer if the 

product being sampled is located at the manufacturer). This initialing and dating is important as it will identify 

these copies of labeling if they are introduced into court at a later date. If the labels/labeling are obtained 

electronically, verify with the dealer that the provided files accurately represent the labels/labeling requested. In 

many cases, labels/labeling may change over time, so ensure that the copies provided are in fact relevant to the 

lot, batch, or unit sampled--particularly for documentary samples where the product and its labeling may no longer 

be present at the dealer.

Prepare a dealer's affidavit on the FDA 463a, being sure to include the relationship of the labeling to the goods. 

This affidavit should include the following information, where relevant:

1. Description of Labeling – Describe, at least briefly, each piece of labeling by name or by using an 

identifiable quote. If labeling contains a revision number or other identifier, include that information (for 

example, a leaflet entitled, "Do You Have Tired Blood", a window streamer entitled, "Amazing New 

Tranquilizer", or an operator’s manual entitled, “ABC Treatment Unit, Model 5600, Revision 1.2). Also note

the quantity of such labeling on hand, when relevant.

2. Location of Labeling - Report the location of each different piece of literature and how much or many is at 

that location. If the labeling and the product are in functional proximity at a point of sale, provide diagrams 

or photographs of their relationship.

3. Method of Distribution - Determine how the labeling is made available to consumers and/or the public. 

Describe how it is displayed, such as: for voluntary pick-up; mailed to prospective customers; distributed 

without being displayed; placed in the shipping container with each product shipment; etc. If the labeling 

and the product are found at a manufacturer or distributor, document the role that the labeling will play in 

the distribution of the product (for example, e.g., to whom will it be sent and when).

4. Source of Labeling - Describe who created/provided the labeling, such as whether the labeling was sent to 

the dealer by the shipper of the goods, or if the dealer prepared the labeling themself, or if it originated 
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from another source. It is important to document this information to establish and “fix” responsibility in 

the event the agency pursues action against that individual/firm. It is not necessary to determine or fix 

responsibility in order to seize the goods. If the labeling may cause misbranding of the products being 

sampled, also document the shipment of the labeling, if a source other than the dealer supplied the 

labeling.

5. Instructions to Dealer - The manufacturer or shipper may provide sales promotion instructions to the 

dealer. Obtain copies of such instructions if available.

4.4.7.2 - Bulk Shipments 

Do not remove the label from bulk containers such as drums, barrels, and large bags, if this will result in 

misbranding the article. Instead, photograph or trace the label if none other is available.

Note: Besides using tracing paper, it is also possible to trace a label on a piece of plastic, similar to a document 

protector, using either a ball point pen or stylus. If it is difficult to read, filling in the tracing with a marker, may 

help highlight the tracing.

4.4.7.3 - Unlabeled or Partially Labeled Lot 

The regulations provide for controlled shipment in interstate commerce of unlabeled goods, but only if:

1. The shipper operates the establishment where the article is to be processed, labeled, or repacked.

OR

1. The shipper, when not the operator of the establishment, has obtained from the owner a detailed written 

agreement signed by the operator. This agreement must contain the post office addresses of both parties 

and describe the specifications and the processing, labeling, or repacking procedures in sufficient detail to 

ensure that the article will not be adulterated or misbranded within the meaning of the FD&C Act, and

upon completion of the processing, labeling, or repacking.

Determine if there is a labeling agreement and obtain copies of pertinent correspondence related to the 

agreement.

4.4.7.3.1 - Documentation 

Collect both unlabeled and relabeled units or specimens of the label to be affixed. Collect specimens of any 

shipping case labels and any labeling accompanied the original shipment.

Obtain evidence showing how the lot was labeled at the time of receipt how the misbranding occurred, and 

who was responsible. Use photographs and diagrams if necessary to portray the present condition of the lot. If 

any of the lot has been resold, collect documentary evidence of the resale.

4.5 - Bioresearch Monitoring (BIMO) Samples 

Samples collected under the BIMO program primarily include bioequivalence samples. Collect and ship these samples 

per Compliance Program 7348.003, In Vivo Bioavailability/Bioequivalence Studies (Clinical), Section 8, Reserve 

Samples, and any specific instructions found in the assignment memo. In addition to CP 7348.003, special instructions 

for BIMO affidavits, collection reports, and sample shipment are included in the sections below. 
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4.5.1 - BIMO Affidavits 

In the BIMO program, affidavits (FDA 463a) will generally be obtained to document violative conditions or unusual 

circumstances observed during an inspection. Additionally, an affidavit will accompany all sample collection reports, 

regardless of whether or not the firm provides a statement on company letterhead attesting that the test and 

reference product reserve samples are representative of those used in inspected BA/BE studies, and that they were 

stored under conditions specified in accompanying records (for example, protocol or labeling). The reason for this is 

because all bioequivalence samples are considered official samples, and as such must be accompanied by an affidavit. 

4.5.2 - BIMO Collection Reports (C/Rs) 

All subs collected for a bioequivalence sample, including investigational product, reference, and placebo, will be 

included on one collection report. A scanned copy of the collection report and all associated documents will be 

uploaded into eNSpect as an attachment to the EIR. Additional instructions specific to certain fields on BIMO C/Rs are 

as follows: 

4.5.3 - Sample Type 

The sample type for all bioequivalence samples will be “Official.” Select “Domestic-Import,” if applicable. Note that

Domestic-Import samples are considered Official; this is just the way the drop-down menu is set up. 

4.5.4 - Sample Description 

Ensure that this field includes a description of the investigational product collected, as well as the reference and 

placebo if applicable. 

4.5.5 - Reason for Collection 

Reference the relevant compliance program (for example, CP 7348.003, “In Vivo Bioavailability- Bioequivalence 

Studies- Clinical”), the assignment memo, and the inspection dates if applicable. Note that there will not be a 

suspected violation for surveillance samples. 

Then add the following statement and edit as appropriate: “Sample of bioequivalence investigational product, 

reference control, and placebo. Sample is representative of test product used in study supporting Protocol (insert 

Study #).” You will specify the analysis desired as follows: “Collected for drug assay analysis.” Include the application 

number (for example, ANDA 12345). 

4.5.6 - Associated Firms 

List all firms related to the investigational product. Associated firms for the reference and placebo can be listed in the 

Collection Remarks field or on a continuation sheet. 

4.5.7 - Product Code and Product Name 

The product code and product name listed should be that of the test article.

4.5.8 - Brand Name 

List the brand names for the test article, reference, and placebo, if applicable. 
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4.5.9 - Product Label 

Quote the label and labeling from the test article, reference, and placebo (if applicable). Be sure to use Collection

Remarks or a continuation if necessary and specify which labeling goes to which product. 

4.5.10 - Sample Flags 

There should be no sample flags for bioequivalence samples, unless the sample is a complaint sample. This is rare. 

4.5.11 - Estimated Value 

It may be difficult to estimate the value of a bioequivalence sample. If the firm is not able to provide you with the value 

of the lot remaining after sampling, use the estimated cost of the innovator if possible. If you cannot provide an 

estimate, leave the field blank and note in the Collection Remarks, “Estimated Value is unknown.” 

4.5.12 – C/R & Records Sent To FACTS Org 

For domestic C/Rs, select your division from the list of values and send the hard copy C/R and all associated documents

to the director of investigations for your division when complete. For samples collected on foreign inspections, select 

the appropriate center/division (for example, CDER-CP for bioequivalence samples) from the dropdown menu and 

send the hard copy C/R and all associated documents to the center/division office contact specified in the assignment 

memorandum.

4.5.13 - BA/BE Sample Shipment 

See assignment memo for current name/ address of laboratory performing sample analysis.

4.6 – Reporting Sample Collections (Completing your C/R) 

For each sample collected, prepare a FACTS Sample Collection Report (C/R). Remember that the C/R is the basis for 

most administrative and regulatory actions. 

The data you enter into specific fields of the report will provide the critical information needed by compliance officers

to capably prepare documents for legal proceedings and to the analyst so that the correct analysis is performed. While 

there may be more than one right way to describe the information you are documenting, the readers of your collection

report rely on your clear and complete descriptions to understand the specific situations you have documented. See 

IOM Exhibits 4-1, 4-2, 4-15, and 4-16 for examples. 

Also note that if changes are needed to the firm data listed in FACTS, you should update the information in the Firm 

Management System (FMS) or contact your division's OEI coordinator for assistance. 

After collection data is entered into the FACTS system, you (the collector) must check the record for accuracy and 

completeness, if appropriate, send it to a supervisor for review, and then sign it electronically. Remember that the 

original data will be stored and permanently associated with this record, and that any future changes to the FACTS 

database reference tables--such as the firm files, employee names, data codes, etc.--will not alter the original data in 

the electronically signed sample collection record.

Ideally, the C/R should be saved before the sample is shipped to the laboratory. Occasionally, you may have to ship a 

sample to the laboratory before saving the C/R. In these cases, at a minimum, the C/R must be saved before the 

sample is received by the laboratory. There are times when you will not be able to enter all information in a C/R before 

you need to save it. The following fields must be completed so that you can save the C/R in FACTS: 
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1. Sample Class 

2. Sampling Organization 

3. Collector 

4. Collection Date 

5. Sample Basis

6. Sample Type 

7. FIS Sample Number 

8. Sample Description 

9. Product Code

10. Product Description 

11. Resp. Firm Type 

12. Resp. Firm FEI Number 

13. PAC 

14. Sample Origin

15. C/R and Records Sent To 

Only the collector has editing privileges for the signed, original sample collection record. As collector, you may modify 

the original record, but revisions should be minimized, and you must electronically sign each revision. All modifications 

of the original record are permanently retained as part of the original record. A permanent electronic record trail is 

created, capturing and retaining every change to original and subsequent records. If retrieval of the sample collection

data is needed, the original record and all changes to the original record can be retrieved. See IOM 4.5 for additional 

information for Bioresearch Monitoring sample collections.

4.6.1 – Sample Type 

Using the list of values, choose one of the following to complete the Sample Type field in FACTS. Identify any 

documents associated with the sample, and the sample itself, with the corresponding prefix, if necessary, followed by 

the FACTS sample number.

4.6.1.1 – Additional Sample (ADD)

To identify an official physical sample collected from a previously sampled lot. However, do not report or 

document as an "ADD Sample" those instances when only additional records or documentation are obtained for 

the sample. See IOM 4.1.4.2.10.

4.6.1.2 - Audit/Certification 

To identify an official physical sample collected to verify analytical results provided by a certificate of analysis or 

private laboratory analysis that purports to show the product complies with the FD&C Act. See IOM 4.1.4.2.8.

4.6.1.3 - Documentary (DOC)

To identify an official sample comprised of documents and photographs, collected without a physical product. See 

IOM 4.1.4.1 and Exhibits 4-1 and 4-2.
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4.6.1.4 - Domestic Import (DI)

To identify an official sample collected from foreign products, which have passed through Customs and entered 

domestic commerce. Note that the country of origin must be reported on the C/R. See IOM 4.1.4.2.5.

4.6.1.5 - Food Standards (FS)

To identify a sample collected to provide information on which to base Food Standards. 

Note: Samples of standardized foods are not FS Samples.

4.6.1.6 - Investigational (INV)

To identify a sample collected to document observations, and/or where interstate commerce does not exist or is

not necessary (for example, environmental swabs, filth samples). See IOM 4.1.5.

4.6.1.7 - Mail Entry 

This sample type is only for import operations and should not be selected in FACTS. (See IOM 4.1.4.2.4.2)

4.6.1.8 - Non-Regulatory 

To identify a sample collected and analyzed by the FDA for other federal, state, or local agencies of products over 

which FDA has no jurisdiction.

4.6.1.9 – Official 

To identify a sample that is representative of a lot of any product covered by the FD&C Act for which interstate

commerce can be documented. See IOM 4.1.4.

4.6.1.10 - Post Award 

To identify an official physical sample collected under the Government-Wide Quality Audit Program (GWQAP).

4.6.1.11 – Post-Seizure (PS)

To identify samples collected pursuant to a court order from a lot under seizure. See IOM 4.1.4.2.3.

4.6.1.12 - Regulatory 

A sample collected or analyzed by non-FDA personnel, including samples submitted by industry. These are usually 

GWQAP samples.

4.6.2 – Preparation 

The C/R is the starting point and the basic reference for all actions and considerations based on the sample. It contains,

or bears direct reference, to every important point about the sample and the lot from which it was collected. See IOM 

Exhibits 4-1, 4-2, 4-15, and 4-16 for examples.

The fields described below are listed in alphabetical order for your ease of reference. (See Exhibit 4-25 for the fields 

listed in FACTS entry order to facilitate completing a C/R. Please note that when a PDF C/R is generated, the field 

names may change on the report.)
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Also, any information that needs to be included regarding the sample, and that cannot be documented via FACTS, 

should be documented on the C/R Continuation Sheet, FDA 464a. (For example, pictorial descriptions of a field exam 

for a filth sample, a description of relative documents and what they demonstrate regarding the subject lot of a 

documentary sample, etc.)

4.6.2.1 - Accomplishment Hours 

Enter the accomplishment data for every sample collected, by clicking on the "clock" icon at the FACTS task bar. In 

the Accomplishment hours screen, enter the PAC by selecting from the list of values and type in the number of 

hours spent collecting the sample. Also enter all PACs that were entered in the Collections PACs field on page 2 of 

the collection record. If another individual is involved in the collection, add their time by clicking on the "Add" 

button. See IOM exhibit 4-16 page 2.

4.6.2.2 - Analytical Assignment 

Select the “beaker” icon on page 2 and enter the sample Collection PACs, Analysis PACs, PAF (Program Area Flag) 

and Lab Organization for your sample. Select the PAC and PAF based on the sample assignment, compliance 

program, or other guidance as appropriate. Select the Lab Organization based on the ORA LST Dashboard, the 

sample assignment, compliance program, or other guidance as appropriate. Note that the analytical PAC and PAF 

may be different from the collection PAC and PAF. Enter any split sample data on separate lines. 

For DOC samples, leave this field blank.

Do not enter any data in this form if the sample is being delivered to a non-FACTS lab.

4.6.2.3 - Brand Name 

Enter the brand name of the product. This is typically found on the labeling of the product (for example, “Blue 

Bunny” carrots). For medical devices, additional research may be required to determine a brand name. It is 

important to identify the product completely so that the compliance officer can communicate accurate 

information to the relevant court and U.S. Marshal in the event of a seizure.

4.6.2.4 - Carrier Name 

Enter the name of the transportation company that transported the goods in interstate commerce (if known at the 

time of preparation of the C/R). You may need to obtain this later to fully document interstate commerce. In the 

case of a 301(k) sample, this is the transportation company that moved the component you are documenting 

across state lines. For a 301(a) sample, used to document the shipment of a violative product in interstate 

commerce, enter the name of the carrier utilized by the manufacturer or distributor to carry the goods across state 

lines. Note that a transportation company is not to be confused with a shipper which is an establishment type and 

the entity responsible for causing the interstate movement of the product. See IOM 4.1.3.4.

4.6.2.5 - Collection Date (Date Collected) 

Enter the sample collection date using the format, mm/dd/yyyy. Note that the default date is today's date—and to 

be careful not to use the default date if the sample was not collected on the date the C/R is created. 

Only one date can be entered if the sample collection was accomplished over several days, use the last day of the 

sample collection. This date should be used to identify the physical sample and any records attached to the C/R. 
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However, you can use the Collection Remarks section to note the additional dates and any other relevant 

information associated with an extended, multi-day sample collection. 

4.6.2.6 - Collection Method (Method of Collection) 

Describe how you collected the sample and which subs are the 702(b) portion, if applicable (See IOM 4.3.2.2 and 

4.3.2.3.). Relate the number and size of the sampled units and subsamples to show how each was taken; note any 

special sampling techniques used; and completely describe the collection method of each sub of selective samples 

with multiple subsamples, including your observations of the conditions. You will normally need to use a 

continuation sheet to describe collection of all subsamples and your description of the lot “bag-by-bag” 

examination. See IOM 4.7.2.1 regarding sub identification.

Example descriptions: 

1. "Two cans of product randomly collected from each of 12 previously unopened cases selected at random." 

2. "Subs collected using aseptic technique and placed in sterile glass jars or whirl-packs" 

3. "Subs 1-10 consist of approx. 1# of product. Subsamples 1-10 collected from bulk storage Bin #1 composited in 

unused, brown, paper bag." 

4. “Two live insects collected from seam of bag #2. Live insects were observed exiting bag, and two were 

collected upon exit.” 

4.6.2.7 - Collection PACs 

Select the appropriate Program Assignment Code (PAC) from the list of values. Select the PAC based on the sample

assignment, compliance program, or other guidance as appropriate.

4.6.2.8 - Collection Reason (Reason for Collection) 

Enter the reason for sample collection to include the compliance program and/or assignment directing the sample 

collection; the analysis desired; the suspected violation, if any; and if collected during an inspection to document 

violations state such and indicates the date(s) of inspection. Identify any inter-division, regional, headquarters 

initiated, assignment document(s) in sufficient detail so the document can be located, if necessary. See IOM 

Exhibits 4-1 and 4-16. 

4.6.2.9 - Collection Remarks 

Enter any remarks you feel are necessary and describe any special circumstances related to the sample. You may 

also use a "C/R Continuation Sheet", FDA 464a if you need more space.

The following information is required if applicable (this list is not meant to be all inclusive): 

1. If a 704(d) [21 U.S.C. 374(d)] letter is indicated, include the name, title, email address (if available), and the 

telephone number of the most responsible individual at the firm to which the analysis results letter should be 

addressed. (IOM 4.6.2.59) 

2. If a 702(b) portion is required per the compliance program, assignment, or policy--but is not collected--

describe the specific circumstance and justification for not collecting the 702(b) portion. (IOM 4.6.2.58) 

3. If the sample is an in-transit sample, state as such, and include the name of the individual (for example, the 

driver) and the firm carrying the good, their telephone number, email, as well as the location where you 

collected the sample. 
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4. If the dealer firm is a consumer, report the name, address, phone number and email of the consumer. Include 

a remark to indicate if the consumer has requested information about the analytical results (see IOM 8.1.3). 

5. If the sample is an environmental sample of a firm, where human and/or animal food is manufactured, 

processed, or packed, include the name, title, email address, and the telephone number of the most 

responsible person at the firm to which the analysis results letter should be addressed. Note: Do not check 

the 704(d) box in FACTS (see 4.6.2.59). Environmental samples do not meet the criteria of 704(d) but FDA 

provides the sample results to firms as described in SOP-000529 and NOT-000068. 

6. If the dealer is voluntarily holding the sampled product, include the name, title, email address, and the 

telephone number of the most responsible person at the firm to which the analysis results letter should be 

addressed. Note: Select the appropriate flag in FACTS as described under 4.6.2.27.3.

7. If the sample is not sealed on the same day it was collected, describe the reason for the delay and the storage 

conditions you’ve employed to ensure the chain of custody of the sample will be maintained. 

8. If the sample is submitted to a non-FACTS affiliation entity (for example, a state) for regulatory action, provide 

the reason you submitted it that entity. (See IOM 4.6.2.16)

9. If the sample is flammable, identify the flash point in °F or °C.

4.6.2.10 – Collector 

As collector, your name will auto populate here. 

4.6.2.11 - Collector's Id On Package/Document 

As the sample collector, quote your identification placed on the packages, labels, etc. (for example, "55563 

12/5/05 SHR"). Samples are to be quoted with the information in the order shown in the example without 

additional symbols, words, or characters. See IOM 4.7.2.3. When multiple units are collected, all or at least a 

portion should be labeled as subsamples. Subsample numbers need to be included on the C/R. You may include 

the sub numbers used in this block outside of the quotes (for example, “55563 12/5/05 SHR” subs 1-30). 

4.6.2.12 - Collector's Id On Seal 

Directly quote the identification you used on the Official Seal applied to the sample (for example, "55563 12/5/05, 

Sylvia H. Rogers, Investigator" Be sure, as in the example, to include your title too. See IOM 4.7.4 and Exhibit 4-17. 

If you use the FDA metal seal, enter the words "Metal Seal" followed by the seal identification and number (for 

example, "U.S. Food and Drug 233"), entering the actual number of the seal used. 

The Collection Remarks field should be used to describe any discrepancy between the date the sample was sealed

and the date it was collected, as normally, the sample should be sealed on the same day as it’s collected. 

4.6.2.13 - Consumer Complaint Number 

If the sample relates to a consumer complaint, enter the complaint number. That way your C/R will be linked to 

the complaint and more readily viewed by the Consumer Complaint Coordinator and other pertinent division and 

center personnel.

4.6.2.14 - Country Of Origin 

Select the country of origin, if known. This field is particularly important when the sample is a Domestic Import

Sample.
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4.6.2.15 – County 

Select the county where the sample was collected (or grown, if a pesticide sample of an agricultural product, for 

instance). This field is particularly useful with regards to pesticide samples as it can aid later communications with 

state officials, in the event of a violative result. Generally, though, this field is usually not applicable for most 

samples. 

4.6.2.16 – C/R & Records Sent To (Orig C/R & Records To) 

Enter the division that is most likely to initiate any regulatory action associated with the sample. This field requires 

some thought on your part, as collector, in consultation with your supervisor. For a 301(k) sample in which the 

dealer is responsible, this is the division where the sample was collected. Additional notes for consideration: Do 

not assume the address on the label is the location where follow-up to a violative sample will be initiated, and do 

not send the records to another division unless you know it is the division of the actual responsible firm. Field 

survey samples will be filed by the collecting division. When a non-FACTS affiliation (for example, a state) is 

selected, provide the reason for doing so in the remarks section.

4.6.2.17 – Controlled Prescriptions and Drug Scheduling 

Controlled Prescriptions (CRx) follow a schedule set by the Drug Enforcement Agency (DEA). Details can be found 

at DEA Drug Scheduling. Choose the appropriate schedule from the list of values, if applicable.

4.6.2.18 - Dairy Permit Number (Permit Number) 

Enter if applicable. If you are collecting samples from a dairy, obtain this number from the firm.

4.6.2.19 - Date Shipped 

Enter the date of interstate shipment in the format, mm/dd/yyyy, if known. Obtain it from the documentation you 

collected to document interstate movement of the product. Identify the document you used to determine this 

date in the “Documents Obtained” section.

4.6.2.20 - Documents Obtained 

Click on the "Documents Obtained” button to enter Document Type, Document Number, Document Date, and 

Remarks for any records collected to support a violation or show interstate movement of the product sampled. 

Enter an identifying number and date for invoices, freight bills, bills of lading, etc. Include the name and title of 

individuals signing any affidavits in the Remarks field. Be sure to describe the reason each document attached to 

the collection record was obtained. (For example, when referring to a bill of lading, indicate that it was collected to 

document the interstate movement of the product.) Also, indicate which documents were collected to document 

specific violations encountered during inspections. State the number of pages for each document if it contains 

more than one page and refer the reader to the appropriate section/page of the document that shows the 

deviation you are documenting. Indicate the number of photographs attached. Depending on the sample and what 

you are trying to document, you may use the document number to record the actual number of the document (for 

example, an invoice number or bill of lading number), or to order the documents attached. You should order your 

documents in a manner that allows easy review (as guided by your supervisor or Compliance Branch). This section 

may also be used to list C/R attachments, including FDA-generated forms. See IOM Exhibit 4-1. 
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4.6.2.21 - Episode Number 

Enter an episode number if applicable. This is a number related to pesticide samples, see IOM 4.6.2.27.8.

4.6.2.22 - Estimated Value 

Enter the estimated wholesale value of the lot remaining after sampling. Obtain this information from invoices or 

other records. (Note: this is not the value to be used for seizure bond purposes; however, it may be used by the 

division to evaluate whether seizure is an appropriate action.) Provide a best-guess estimate value if you have no 

documentary reference. For DOC samples (see Exhibits 4-1 and 4-2), indicate the estimated value of the lot. If the 

DOC sample is collected to document a lot that has already been shipped, estimate the value, or obtain a figure 

from your documentation that is representative of what was shipped. 

4.6.2.23 - FEI Number 

The FEI number is a unique identifier used to identify firms associated with FDA-regulated products. Enter the FEI,

if known, or use the “B” button to query FMS and find the FEI for the firms associated with your sample. If an FEI

does not exist, you may need to add the firm to the FMS. Take care in entering search criteria to avoid creating 

unnecessary FEI numbers--consult your division OEI coordinator for assistance. Note that you must enter an FEI for 

a dealer on every C/R, unless you check the box indicating the dealer is a consumer.

4.6.2.24 - Firm Name 

This will be auto-filled by FACTS when you select an FEI.

4.6.2.25 - Firm Type 

Using the list of values, select one of the following for each FEI entered, with respect to the product sampled:

4.6.2.25.1 – Dealer 

This is always the firm from which the sample was collected. There must be a dealer entered on every C/R, 

unless you check the box indicating the dealer is a consumer. Note: this is not the same as the establishment 

type of the firm identified by the FEI. However, there are circumstances in which you may identify the same 

firm as the dealer and another establishment type, such as when collecting a plant in-line sample.

Note: If the dealer firm is a consumer, the name and address of the consumer should be entered in the 

Collection Remarks field, and the consumer's state in the State field. When the sample is an in-transit sample 

(see IOM 4.1.4.2.1), enter the consignee of the lot as the dealer and be sure to state in the Collection Remarks 

field that the sample was collected in-transit, and from whom sample originated (for example, name of driver 

and their carrier firm), and where sampled.

4.6.2.25.2 – Grower 

Select "Grower" if the FEI identifies a producer of a raw agricultural commodity.

4.6.2.25.3 – Harvester 

Use "Harvester" for an FEI identifying the harvester of the product sampled.
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4.6.2.25.4 - Ingredient Supplier 

"Ingredient Supplier" should be used to identify a firm that supplied a raw material or component (for 

example, as when documenting a 301(k) [21 U.S.C. 331(k)] situation).

4.6.2.25.5 – Manufacturer 

Use "Manufacturer" with an FEI, which identifies the manufacturer of the product sampled. Note: this may be 

the same as the dealer when a product is sampled at a manufacturer. In this case, you can enter the FEI twice

and identify it as both the manufacturer and the dealer.

4.6.2.25.6 – Repacker 

A repacker is a firm that repacks FDA-regulated products without manipulating the product or relabeling it.

4.6.2.25.7 – Shipper 

The shipper is the firm responsible for causing the interstate movement of the product. Note this is not to be 

confused with the Carrier, the entity physically moving the product interstate.

4.6.2.26 - FIS Sample Number 

Enter the last two digits of the fiscal year. The remainder of the number will be assigned by FACTS. Note: FIS sample numbers will no longer be required when the FIS is turned off.

4.6.2.27 – Flag 

Flags are used to alert readers of your C/R to what the sample is documenting and any special circumstances 

related to that sample. The Sample Flag will be printed at the top of your hard copy C/R. For example, when you 

collect a 301(k) sample, the flag will indicate that this is a 301(k) sample and alert the reader to the fact that you 

are documenting adulteration after shipment in interstate commerce. The following situations require an entry in 

the Sample Flags screen in FACTS (See IOM section 4.6.2.49 and Exhibit 4-15):

4.6.2.27.1 - 301(K) Sample 

Use this flag when the sample meets the definition of a 301(k) sample (IOM 4.1.4.2). Use the Flag Remarks 

field to state the product or ingredient that you documented as moving in interstate commerce.

4.6.2.27.2 - Complaint Sample

Use this flag for any sample collected from a complainant during follow-up investigation.

4.6.2.27.3 - Dealer Voluntarily Holding

Use this flag when the dealer is voluntarily holding product until sample results are received. This information 

will be important for the compliance officer to know when preparing a seizure or other regulatory action. This 

information needs to be entered as soon as the C/R is created, so the laboratory can adequately prioritize 

sample analysis and provide a timely notification to the firm.

4.6.2.27.4 - Exhibit Sample

Use this flag when the sample is to be used exclusively for court exhibit, without analysis.
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4.6.2.27.5 - Factory Food Sample

Use this flag when sample(s) of any item, used in the production of any food product, are taken during the 

establishment inspection. However, do not use this flag for finished product samples or for environmental

samples. See IOM 4.3.6.6.3.

4.6.2.27.6 – Fumigated 

Use this flag when the product has been fumigated by the FDA prior to shipping, see IOM 4.7.3.1. Enter the 

name of fumigant in the Flag Remarks field. However, do not use this flag for products that may have been 

fumigated by someone else prior to sampling.

4.6.2.27.7 - Inv. Samples Of Filth Exhibits 

Use this flag when the sample consists of filth (for example, gnawings, excreta pellets, wood splinters, etc.) 

collected from a product or its environment. These samples are Investigational Samples and the prefix INV is 

added to the sample number when identifying.

Enter the product code of the filth exhibits in the Product Code field of the FACTS Sample Collection Screen. 

Note the product code for exhibits consists of the Industry Code followed by "YY-99" or "Y--99" as below:

In a food firm = 52YY-99

52 = Misc. food related items

Y = Exhibits

Y = Sub class - None

- = Dash

99 = Evidence exhibits n.e.c.

In a drug firm = 66Y--99

66 = Misc. drug related

Y = Exhibits

- = Dash

- = Dash

99 = Evidence exhibits n.e.c.

Other industries: Handled in same manner using applicable industry code(s).

4.6.2.27.8 - Pesticide Sample 

After flagging a pesticide sample, the basis for sampling must be entered in the Flag Remarks field as either 

"Pesticide Compliance" or "Pesticide Surveillance." Additionally, the name of the county and state, or country 

where sample was grown, must be entered in the appropriate fields in the Collection Record.

Pesticide Episode – Such an "episode" is defined as a violative finding associated with a pesticide, or other 

chemical contaminant, and all samples collected in follow-up to that finding. All samples must be associated 

with one responsible firm (grower, pesticide applicator, etc.) and one specific time period (for instance,

growing season). 

Here are a few examples of pesticide episodes and points of clarification:

1. Samples of cantaloupes from Mexico reveal violative residues. Note: Any destination point samples or 

subsequent compliance samples from the same shipper or grower, along with the original sample,

would be considered an episode.

2. Grower Jones has violative residues of chlorothalonil on collards for which there is no tolerance. Note: 

Field samples, I.S. samples, and packing shed (or warehouse) samples of these collards would all be 

part of the same episode.

3. Grower Jones also has violative residues of omethoate on kohlrabi that are discovered about two 

months later. Note: This is a separate episode.
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4. Along with the omethoate on kohlrabi, Grower Jones has violative residues of omethoate on beets. 

Note: Normally this would be considered a separate episode from the previous episode; however, if 

information is or becomes available showing that both residues resulted from the same application of 

the pesticide, or that the residues are/were closely related in some other way, the beets might be 

considered as part of the kohlrabi episode.

5. Grower Smith has violative residues of disulfoton and permethrin on kale. Note: This would be 

considered one episode because only one commodity is involved.

Also note that the Episode Number will be the sample number of the first violative sample collected in a series 

of samples and is used to identify the other related samples within an episode. The division must ensure that 

the same and correct Episode Number is used within the division, and any other divisions, involved in any

follow-up to the original violative sample. This number must appear in the Episode Number field of the FACTS

C/R.

Note for Imports: The detention without physical examination procedures provide for recommending 

detention based on a single violative pesticide finding. See RPM Chapter 9-6. Given these procedures, we can

anticipate that the number of compliance samples collected in follow-up to a violative finding should likely

diminish appreciably and, in most cases, will be limited to occasional audit samples. These follow-up samples 

should also be linked to the sample number (episode number) of the original violative sample that prompted 

the automatic detention. This episode number will be indicated in the applicable Import Alert.

4.6.2.27.9 – Produce Related Result Requested 

Use this flag when samples are collected of Raw Agricultural Commodities.

4.6.2.27.10 – Public Land Sample 

Used primarily by the produce program. Samples collected on public land (not owned by any firm or farm). Use 

this flag for public water samples. 

4.6.2.27.11 – Reconditioned 

Use this flag when a sample is collected in connection with a reconditioning operation in accordance with a 

court order.

4.6.2.27.12 - Split Sample 

Use this flag when a sample is divided between two or more laboratories.

4.6.2.27.13 - Survey Sample 

Use this flag for any sample collected under a compliance program or assignment that identifies the samples 

are collected as part of a survey. Also, use this flag for any sample collected under the Drug Surveillance 

Program (CPGM 7356.008); in which case you should enter the survey number in the flag remarks section.

Note that SCOPE and Total Diet Study samples are not generally considered Survey Samples.

4.6.2.27.14 - Under State Embargo 

Use this flag when the lot is being held under state embargo. Enter the point of contact, their contact 

information, and how long the embargo is in effect, in the Flag Remarks field.
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4.6.2.28 - Food Canning Establishment 

Enter Food Canning Establishment Number if applicable. Information on Food Canning Establishment registration 

can be found at: Food Canning Establishment Registration Information. 

4.6.2.29 - Hours 

This is automatically populated on the hardcopy C/R based on your Accomplishment Hours (See IOM 4.6.2.1). 

4.6.2.30 - How Prepared 

Explain how the sample was prepared prior to submission to the laboratory, including how you identified some or 

all of the units, and how you wrapped and sealed the sample. Also, note any special preparation methods, such as 

fumigation, freezing, refrigeration, etc., and the state in which the sample was delivered to the laboratory (for 

example, in paper bags, original container, etc. If coolants or dry ice were used, also indicate that here. It is 

important to be specific about how you protected the integrity of the sample and the chain of custody (for 

example, “Subs identified as noted, placed in unused, brown paper bag; bag taped shut and FDA seal completed 

(as noted) and applied, bag identified as noted in pen/ink. FDA 525 attached to sealed bag, placed in brown,

cardboard box and prepared for shipment, then delivered to division security guard desk for UPS pick-up”). If a 

702(b) portion is collected, describe how that portion was handled and prepared as well. See IOM 4.3.2.2 and 

4.3.2.3. If the sample was collected by multiple participants, clearly explain which steps were performed by each 

participant. 

4.6.2.31 - Lot Size 

Enter the amount of goods that were on hand before sampling as determined by your inventory of the lot. Include 

the number of shipping cases and the size of the components (for example, 75 (48/12 oz.) cases, 250/100 lb. 

burlap bags, 4/100,000 tab drums, 24 cases containing 48/12/3 oz. Tins). 

For DOC samples (see Exhibit 4-1 and 4-2) indicate the size of the lot manufactured as described in the records

collected, e.g., “one x-ray machine” or “5000 syringes.” In the remarks section, describe the amount of any 

product remaining on hand at the time the DOC sample was collected. 

If accompanying literature is involved, for either a DOC or physical sample, describe and state the amount on hand

(for example, “5000 syringes and 1000 promotional brochures”).

4.6.2.32 - Manufacturing Codes 

Click on the "Manufacturing Codes" button to enter and identify all codes, lot numbers, batch control codes, etc., 

and how they are displayed on labels, containers, and shipping containers. Enclose the code in quotes. For 

example, code embossed on can cover, "87657888" or code applied in ink on side of container, "0987878." Also 

indicate the manufacturing codes used on products for which a DOC sample was collected--for example, "serial 

number "ABC" stamped on metal plate." See IOM Exhibit 4-2.

Enter any expiration dates in the Exp. Date field.

4.6.2.33 - National Drug Code (NDC) 

Enter if applicable
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4.6.2.34 - Payment Method 

Select one of the following from the from the list of values: "Billed," "Borrowed", "Cash," "Credit Card", "No 

Charge," or "Voucher." (The “Credit Card” option means you used your personal credit card as a last resort.) 

4.6.2.35 - Product Code 

Enter the 7-character product code, consulting the Product Code Builder for guidance. Note, too, that when 301(k)

samples are collected, the full product code of the finished product must be entered. See IOM Exhibit 4-1. See IOM 

4.6.2.27.7 for product codes for filth or evidence exhibits. Other special product code considerations include 

environmental samples. See environmental sample identification instructions under IOM 4.3.6.6.2.

4.6.2.36 - Product Description 

Enter a complete description of the product including the common or usual name and the product 

packaging/container system. (For example, “Aspirin tablets packed in clear, non-flexible plastic bottle with white 

screw on top with yellow stick-on label and black printing. Bottles packed in white, paperboard boxes with black 

printing. Paperboard boxes packed in brown cardboard boxes with black printing.”) If you need additional space, 

continue the description in remarks. See IOM Exhibit 4-1.

4.6.2.37 - Product Label 

Quote pertinent portions of the label, such as: brand name, generic name, quantity of contents, name and address 

of manufacturer or distributor, code, etc. In the case of drugs, quote the potency, active ingredients, and indicate 

whether an Rx or non-Rx. Quote sufficiently from accompanying literature to fully identify. In the case of a DOC, 

sufficiently describe the article to adequately identify what has been sampled.

NOTE: When the product sampled is packaged in a container, shipping case or similar container, quote the 

pertinent labeling from the container.

When quoting from a label, or labeling, use exact spelling, capitalization, punctuation, arrangement, etc., as found 

on the original label(ing). Do not insert [sic] within the quote to highlight when a word is misspelled. Use asterisks 

in a series of three (***) to indicate any omissions.

4.6.2.38 - Product Name 

Product Name field is auto-completed by FACTS when you select the product code. 

4.6.2.39 - Recall Number 

If the sample was collected as part of a recall investigation, in which the recall number is already known, enter the 

recall number.

4.6.2.40 - Receipt Issued (Receipt Type) 

Select "FDA472", "FDA484", or "None" from the list of values.

4.6.2.41 - Related Samples

This field is used to identify a sample number to which other sample information can be linked. When you collect

more than one sample from a single shipment, or there is more than one sample relating to a possible regulatory 
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action, designate one sample as the "lead" sample. Enter that sample number in this field of the collection record 

for each related sample. Other related sample numbers should be listed in the Collection Remarks field.

4.6.2.42 - Resp. Firm Type 

Choose the appropriate type from the list of values for the firm most likely to be responsible for a violation. For a 

301(k) [21 U.S.C. 331(k)] sample, the responsible firm should be "Dealer." You should only enter one firm with the 

firm type you designate as the responsible firm type.

4.6.2.43 - Sample Basis 

Select from the two choices, as described below, on the list of values. 

"Compliance" means the sample was collected on a selective basis as the result of an inspection, complaint, or 

other evidence of a problem with the product. "Surveillance" means the sample was collected on an objective 

basis where there was no inspectional or other evidence of a problem with the product. 

Please note that official samples can be either compliance or surveillance in nature, and that INV samples can also 

be either. See IOM Exhibit 4-16 for more information.

4.6.2.44 - Sample Class 

Make a selection from the following list of values: "Collaborative Study," "Criminal Investigation," "Division Use 

Sample", "Normal Everyday Sample," "Petition Validation," "Quality Assurance," "State Partnership," or "Total 

Diet." 

4.6.2.45 - Sample Cost 

Enter the cost of the sample. If no charge, enter 0. If, as a last resort, you use your personal credit card to pay for 

the sample, enter the amount paid in this field and select "Credit Card" in the Payment Method field. If you are 

unable to determine the cost of the sample and the firm states that they will bill you later, enter the estimated 

cost in this field and state that it is an estimate in the Collection Remarks field.

4.6.2.46 - Sample Delivered Date 

Enter the date on which the sample was delivered to the laboratory or for shipment. For DOC samples, you must 

leave this field blank. If you make an entry, you must enter a laboratory.

4.6.2.47 - Sample Delivered To 

Enter the person to whom you delivered the physical sample. If delivered to your own sample custodian under 

seal, show delivery to servicing laboratory or sample custodian. If delivered in-person to an analyst, report "In 

person to Analyst Richard R. Doe." If you shipped the sample, enter the name of the carrier to whom the sampled 

was delivered. Also, enter the carrier shipment tracking number. If the sample is shipped by air, enter the air 

waybill number. If shipment is by parcel post, give the location of the post office (for example, "P.P., Austin, TX") 

For a DOC sample, this field may be left blank. If the sample is being sent to a non-FACTS laboratory, enter the 

laboratory here.
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4.6.2.48 - Sample Description 

Briefly describe what the sample consists of (for example, three unopened, 200-tablet bottles; 20 lb. case of 

iceberg lettuce; or DOC sample consisting of records, literature, and photographs, etc.).

4.6.2.49 - Sample Flags 

Click on the "Sample Flags" button to choose an appropriate flag using the list of values. See IOM 4.6.2.27 and 

Exhibit 4-15.

4.6.2.50 - Sample Number 

Select the pre-assigned sample number using the list of values. Be certain the Sample Number matches the one 

you used to identify the sample. If no value is selected the system will generate a sample number when the record 

is saved.

4.6.2.51 - Sample Origin 

Choose "Domestic" or "Domestic/Import" from the list of values.

4.6.2.52 - Sample Sent To 

Collecting divisions are instructed to submit samples utilizing the Lab Servicing Table (LST) Dashboard located on 

the intranet on the ORS Sample Distribution site. See IOM 4.6.4. If you are splitting the sample among multiple 

laboratories for various analyses, enter each laboratory separately. Generally, in that case you will have more than 

one PAC code. If, because of your assignment, you are aware the sample should be forwarded to a second 

laboratory after the first analysis is complete, include that information in the Collection Remarks field. However, 

you should only enter a laboratory in this field if you are sending the sample there, not if the laboratory will be 

expected to forward it. For a DOC sample, leave this blank. If the sample is to be sent to a non-FACTS lab, leave this 

field blank, enter the lab in the Sample Delivered To field, print a copy of the collection record and enclose it in the 

FDA 525 attached to the sample. 

4.6.2.53 - Sample Type 

Make a selection from the list of values. You can enter only one value. If more than one type applies, choose one 

and indicate the other in remarks. If the sample is a domestic import, be sure to enter "DI", so that you can enter 

the foreign manufacturer. See IOM 4.6.1. 

4.6.2.54 – Sampling Organization 

Make a selection from the list of values. This should be the division that actually collects the sample. 

4.6.2.55 – State 

Select the state from where the sample was collected. If the dealer firm is a consumer, select the consumer's state. 

4.6.2.56 – Status 

This field is pre-filled by the system as "In-Progress." Select "Ready for Review" from the list of values when you 

are ready to send the record to your supervisor for review, if you are required to do so. After supervisory review, if 

appropriate, change the status to "Complete." This will cause the electronic signature form to be activated. 
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4.6.2.57 - Storage Requirements 

Select from the following list of values: 

1. Ambient – Used to indicate product is stored under conditions in which the temperature is not controlled. 

2. Frozen (self-explanatory). 

3. Refrigerated (self-explanatory). 

4. Flashpoint – Used to designate the flashpoint of a flammable substance (Identify the flash point in °F or °C in 

the ‘Remarks’ section). 

Note: This field is not required for DOC samples. 

4.6.2.58 - 702(b) Portion Collected 

Check this box if the sample you collected contains a 702(b) portion of any food, drug, or cosmetic to be held by 

FDA for release to the owner or person named on the label for their own analysis. This includes samples in which

1) the sample schedule already accounts for the 702(b), 2) you collected in duplicate and separated the duplicate 

out and 3) you collected in duplicate and did not separate the duplicate out. If you did not separate the 702(b) 

portion, note this in the remarks so the laboratory can separate the 702(b) portion. If no 702(b) portion was 

collected, do not check this box and provide reason for non-collection in the Collection Remarks section (See IOM 

4.3.2.2 and 4.3.2.3).

4.6.2.59 - 704(d) Sample 

Check the 704(d) box if all answers to the following questions are “yes,”:

1. Was the sample collected a food?

2. Was the sample collected during an inspection?

3. Was the sample collected from an establishment where food is manufactured, processed, or packed?

4. Was the sample collected to ascertain whether such food consists in whole or in part of any filthy, putrid, or 

decomposed substance, or is otherwise unfit for food?

Note: Guidance on 704(d) is provided in FMD-147 including examples of what constitutes “unfit for food”. 

Include in the Collection Remarks the name, title, email address (if available) and telephone/fax number of the

most responsible person at the firm. See also IOM 4.6.2.9.

4.6.3 –Lab Servicing Table (LST) Dashboard 

Collecting divisions are instructed to submit samples utilizing the Lab Servicing Table (LST) Dashboard located on the 

intranet on the ORS Sample Distribution site. The LST Dashboard is an interactive tool showing respective sample 

capacities by PAF and servicing lab. The LST Dashboard can be used to identify all servicing labs with current available 

capacity for a selected PAF. Special notes or instructions are also included on the LST Dashboard, which may include 

directions pertaining to diversions and/or suspensions. 

The Lab Servicing Table (LST) will continue to be updated as a reference. The LST Dashboard is a supplement to the LST.
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When completing a sample collection, the Lab Selection screen will include a "Lab Reference" button that links to the 

LST Dashboard. After referring to the LST Dashboard to identify a lab with available capacity, select the appropriate 

servicing lab via the listed laboratory values. 

4.6.3.1 – Other Information 

The Office of Regulatory Science intranet website maintains current documents related to the Laboratory PAF 

managers Contact List and the Division Compliance Contacts. Questions on sample analyses, assignments, 

laboratory capability, or otherwise can be directed to the Office of Regulatory Science contacts listed at that site.

Additional information on sample collections and laboratories, including assignments, SCOPE and contacts, can be 

found at: The link to Field Guidance and Field Programs.

Also reference 4.7.5.4 - Routing of Samples.

4.6.4 – Routing 

Anyone who has user access to the FACTS system has access to the electronic records contained therein, including 

sample collection records. Individuals requiring sample collection data can query the system and retrieve data, based 

on the query parameters. In those cases where an individual needs to receive immediate notification of a sample 

collection, the collector may communicate the sample number via email, telephone, or another means to a user, and 

the user may then query the system and obtain the desired data. It is not always necessary to print paper copies of 

FACTS sample collection records for those who have access to FACTS.

Follow division or program procedures for submitting C/Rs. If there is no established procedure, forward C/R from 

FACTS and original hardcopy or electronic records through your supervisor to the division office compliance branch 

most likely to take regulatory action. 

4.7 - Sampling: Preparation, Handling, Shipping 

4.7.1 – Objective 

The preparation, handling, and shipping of samples is your responsibility, and must be carried out in a manner that

assures the sample's integrity and supports testimony that the sample examined was the same sample you collected 

from the documented shipment. Samples need to be kept under lock, or in your possession, until sealed. 

As few persons as possible should handle the sample to reduce the likelihood of compromising sample integrity. In 

order to maintain “chain of custody,” it is important that properly packaged and identified samples be opened only by 

the sample custodian(s). See ORA Lab Manual, Volume II, Section 5.8 for information about relinquishing samples.

4.7.2 - Identifying Marks 

4.7.2.1 – Subsamples 

Identify a representative number of subsamples (subs) with the sample or entry number (including prefix, if 

appropriate), collection date, and your initials. If individual sub identity must be maintained, assign and mark each 

sub with a separate number. In some comprehensive inspections or investigations, it may be important to 

correlate the manufacturing control code with the sub number.
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When a variety of articles are included under one sample or entry number, fully identify each sub and describe 

them on the C/R. Subsamples from an INV sample should be fully identified and, where appropriate, correlated 

with inspectional observations, manufacturing procedures, and/or routes of contamination. See IOM 4.2.5.6 for 

using the FDA 484 - Receipt for Samples as a memo to accompany C/R to describe subs collected.

When multiple subs are taken from cases, bales, boxes, etc. in the lot, numerals and letters in combination may be 

used for identification. For example, if two cans are taken from each case in the lot, the cans may be marked as, 

subs 1a, 1b, 2a, 2b, etc., to identify the subs as coming from case #1, case #2, etc. If the second can or container 

taken from each case is the 702(b) [21 U.S.C. 372(b)] portion, it is desirable that all duplicate portions be sealed

separately from the FDA portion. This fact should be so noted on the cases and C/R.

If multiple subsamples are to be collected, it may be advantageous to place identifying information--such as sub 

number, sample number, your initials and collection date--on peel-off labels, tape, etc., in advance of sampling to 

save valuable time.

Do not place peel-off labels directly on cans for canned food samples collected for-cause as these can interfere 

with the analysis.

4.7.2.2 - Borrowed Samples 

Although most samples are purchased, some may be borrowed, non-destructively examined, and returned to the 

owner. These samples must be handled carefully to avoid defacing or damaging the product. 

Identify borrowed samples so the identification can be removed with no damage to the product (for example, a 

sample bearing a sticker label that can be peeled off). 

4.7.2.3 - Identification Techniques 

Mark a representative number of subsamples with the sample or entry number, collection date, and your initials. 

Similarly identify any outer packaging, labels, or circulars. If more than one person is involved in collecting the 

sample, the person preparing and signing the C/R is the one to initial the subs. After identifying them, reinsert 

circulars removed from packages. See IOM 4.3.1.2 for procedures on identifying lots from which sample was taken. 

Transparent tape, such as Scotch Magic Transparent tape, accepts ball point ink and may be used on glossy items 

such as glass, plastic, tin, etc. Glass, such as bottles, vials and ampoules, may be identified by using a very finepointed felt or nylon marking pen and then covering the identification with transparent tape for protection. 

Fine point Sharpie (permanent ink markers) may be used on paper labels. Note, too, that permanent ink markers 

freeze at a lower temperature than ball point pens and other markers when you find yourself sampling in freezers, 

or outside when it is below freezing (32°F/0 C). Do not use permanent-type markers when identifying subs in 

absorbent containers as the ink may penetrate into the product and contaminate the sample (for example, flour in 

a bag with no outer plastic layer). 

Also, do not use tape on very small containers, such as ampoules, which must be snapped off or broken to remove 

the contents for analysis as tape wrapped around the container may interfere with the assay. 

4.7.2.4 – Photographs 

Unless they are part of a DOC Sample or are used to show labels or labeling, photographs are exhibits to an EIR, 

report of investigation, or complaint--they are not samples. Photos taken during inspections and investigations are 
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not described on a C/R, but are submitted as exhibits with the EIR. Photographs related to DOC samples, including

those of labeling, records, or the product, are identified with the sample or entry number, collection date, and 

initials. If photos are printed direct from film, identification of the original photo should occur on the border or 

backside. See IOM 4.4.2. Attach any photos to the FACTS Collection Record. 

In describing photographs, do not mark the face of the print. Narrative descriptions may be placed on the 

mounting paper next to the print or, if explanatory graphics are required, you may use a plastic overlay. See IOM 

5.3.4.2.3 for negative identification and submission procedures, and IOM 5.3.4.3 for digital photos.

For imports photographs: See IOM 6.2.8– Photographs: Identification and Storage. 

4.7.2.5 - Records - Accompanying Literature and Exhibits 

Identify all copies of sample records, accompanying literature, and attached documents with the sample or entry

number (including prefix, if applicable), collection date, and your initials, as described in IOM 4.4.2. If an attached

document is more than one page in length, it must be numbered or attached in a manner that will always allow 

future reviewers to determine if any pages are missing. For example, numbering pages as in “1 of 10,” or “2 of 10,” 

etc., will let the reviewer know that a total of 10 pages should exist in the attachment.

4.7.3 - Sample Handling 

All samples must be handled, packaged, and shipped to prevent compromising the identity or integrity of the sample. 

Samples must be packed with shock-absorbing materials to protect against breakage of containers or damage to

official seals. Frozen samples must remain frozen. Perishable products may be frozen if freezing doesn't interfere with 

the planned analysis (for example, analyzing milk for drug residues). If you are not sure about any handling procedures, 

please check with the relevant laboratory. Products requiring refrigeration (for instance, fresh crabmeat undergoing

bacteriological analysis) should be shipped in ice. Some products may be collected at room temperature but will need 

to be refrigerated or shipped under refrigeration. For example, this includes raw agricultural products collected in the 

field for microbiological analysis. Use your experience and knowledge to determine the most appropriate packing and 

shipping method and consult with the analyzing lab about any questions you have regarding sample handling. 

4.7.3.1 – Fumigation 

See IOM Safety Chapter regarding fumigation and preparing samples using fumigation (IOM 

S.12.6.2).

As soon as possible, freeze any sample containing, or suspected to contain, live insects, as long as 

freezing will not change or damage the product or break the container. If freezing is inappropriate 

to maintaining the integrity of the sample, fumigation may be carried out using air-tight containers (such as a 

mason-type jar with inner ring, or a polypropylene container with air-tight lid), with sufficient fumigant to kill the 

insect infestation. Contact your servicing laboratory for alternative fumigants.

Moth crystals, containing paradichlorobenzene (PDB), are an alternative fumigant. However, do not use mothballs 

or moth flakes containing naphtha or naphthalene. Also, do not use moth crystals in or near plastics, particularly 

Styrofoam/polystyrenes, as crazing or melting may occur. Other alternative fumigants include liquid household 

ammonia or ethyl acetate--either of which can be used by applying to a cotton ball that is placed inside an 

appropriate container; or by cutting small portions of commercial pesticide strips that are also placed in an 

appropriate container. 
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4.7.3.1.1 - Fumigation Safety Precautions 

Follow safety precautions when fumigating samples. Contact your local servicing laboratory or l Safety Data 

Sheet (SDS) for the appropriate protective gear and handling of fumigants. Additional guidance:

1. Carry all alcohols, fumigants, and other hazardous liquids in approved safety containers.

2. When fumigants or preservatives are used, limit your exposure to these chemicals. Minimize transfer 

and exposure time. Avoid getting chemicals on hands or clothing. DO NOT MIX CHEMICALS.

3. Ensure that DOT regulations and guidance and International Air Transport Association (IATA) 

guidelines are followed when mailing or shipping samples containing a fumigant or preservative. 

Exceptions applying to small quantities are listed in 49 CFR 173.4. 

4. The sample identification data on your packaging, the FDA-525 and C/R, must always identify the 

fumigant and method of fumigation, and/or preservative used.

5. Safety Data Sheets (SDS) for each chemical fumigant or preservative used must be available at each 

duty site and enclosed with the shipped sample. Read and follow all instructions and precautions listed 

on the SDS.

4.7.3.1.2 - Procedures For Fumigation 

Place a small amount of fumigant, in an airtight container. Separate the fumigant from the sample with a piece 

of paper, paper napkin, or unscented facial tissue. Put specimen or product into container and seal tightly. Do 

not reopen container unless absolutely necessary. If possible, use a glass container with a lined screw lid. A 

mason-type jar with inner ring is also acceptable.

4.7.3.1.3 - Exceptions To Fumigation 

When submitting samples or exhibits to show live infestation, do not fumigate. Be sure to consult with your 

supervisor or your servicing laboratory PRIOR to sending or bringing a live infestation into the laboratory to 

permit preparation for proper handling and storage. Also, do not fumigate samples submitted for pesticide

residue analysis.

4.7.3.1.4 - Preservation Liquids 

Insects may be killed and preserved in 70% ethyl alcohol, or a 1:1 mixture of 70% ethyl alcohol and glycerin 

(may be labeled as glycerol). These chemicals can be obtained from your servicing laboratory. Do not collect

rodents or animal tissues unless specifically instructed. Ensure all vials or bottles of preservation liquids are 

tightly sealed to avoid leakage. Identification labels may be placed in containers but must be written in India 

ink or 2H pencil only. Keep all preservation liquids away from excessive heat or open flame.

Identify the preservative used on FDA 525, C/R, and on sample container. Enclose a copy of the SDS with the 

shipped sample. Follow DOT and IATA guidelines when shipping or mailing samples with preservatives as 

stated under Fumigants. 

4.7.3.2 – Samples for Label and Labeling Review 

Samples collected for label review only should be officially sealed in clear plastic bags. This will permit cursory 

review and, if necessary, photographing or scanning of the container label and reduce the need to break the seal 

each time the label is examined. 
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Samples may alternatively be collected of the product and the label field-stripped from the container. The product

can be destroyed either onsite where it was collected, or in the office. The stripped label could also be submitted 

as part of a DOC sample. (See IOM 4.1.4.1). Be sure to document in your C/R all actions related to stripping the 

label and destroying the product.

4.7.3.3 - Samples for Pathological Examination 

Tissue samples are not routinely collected for microscopic or pathological examination. Authorization must be obtained from the appropriate Center before collecting samples of this material.

When assigned to collect tissue samples, unless directed otherwise by the program, the assignment, or your 

supervisor--cut the tissue into 1/4-inch pieces and preserve in 10% buffered formalin, or in other suitable 

preservatives as directed. Do not freeze the sample since frozen tissue is not suitable for pathological studies.

4.7.3.4 - Small Sample Items 

Samples in small vials, bottles, boxes, and similar type containers may be placed inside the FDA 525 envelope after 

identification. When the envelope is used as the sample package, place the official seal across the glued flap and 

the blank face of the form.

If the sample container (vial, bottle, etc.) is officially sealed, it may be placed in the same FDA 525 together with 

copies of the assignment.

4.7.3.5 - Frozen Samples 

You should pre-chill sterile containers before collecting frozen samples. Also, transfer liquids in glass to expandable 

containers before freezing. If the liquid must be frozen in glass, leave sufficient headspace to allow for expansion. 

If freezer facilities are not available or if the sample is to be shipped, pack with dry ice in insulated containers.

Note: Dry ice may be obtained from ice cream or dry ice dealers.

Your district office or resident post should have insulated shipping containers on hand, but if there are none, 

economical polystyrene (Styrofoam) containers are available at most variety stores. However, most polystyrene 

containers are not designed for shipping so will need to be packaged carefully inside shipping cartons to protect 

them during shipment. Note: If your division desires the return of Styrofoam freezer chests or ice packs used in 

shipping samples, note this fact on the C/R and FDA 525.

Caution: Dry ice is potentially dangerous and requires caution in handling and shipping. Do 

not handle with unprotected hands; or transport in your car without adequate ventilation; 

or place inside tightly closed metal, plastic, or similar type containers that do not breathe. If 

it is necessary to use this type of container, adequately vent it to prevent pressure buildup. 

Do not use glass containers for packaging or for storing dry ice. (Note: Failure to adequately 

vent a container containing dry ice may cause a dangerous pressure buildup, resulting in serious risks to personal 

safety (to you or anyone else potentially handling the container) and sample integrity).

Note: If a sample is to be analyzed for ammonia contamination, it must not be shipped frozen in dry ice. Use other 

methods of freezing if frozen shipment is necessary.
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4.7.3.5.1 - Shipping Frozen Samples 

If using a U.S. Government BOL, it is important to give a full and accurate description of the sample for rate 

purposes. If more than one commodity is in the shipment, describe and enter each sample separately.

Dry Ice Guidance

In all packages where dry ice is used, distribute the dry ice equally on all sides of the sample package using 

pieces as large as possible. Be sure the container is insulated on all six sides and tape all edges securely to 

assist in insulating the carton. However, do not place dry ice inside officially sealed packages.

Freezing by dry ice is not effective for more than forty-eight hours. For overnight shipments, use at least one 

pound of dry ice per pound of sample. Increase the amount for longer hauls or unusually warm weather. 

(Note: When samples are in plastic-type containers, the dry ice must be wrapped in paper to prevent direct 

contact with the plastic as the extreme cold generated by the dry ice may cause the plastic to become brittle 

and rupture.

All shipments involving dry ice should be next day or sooner delivery. Tests have shown the following amounts 

of dry ice will be adequate when this method is used:

For samples already in frozen state: 5 to10 pounds of dry ice, depending on sample size, is normally sufficient. 

For samples requiring only to be refrigerated: A minimum of ten pounds of dry ice is sufficient.

Note the following practices for shipping dry ice with respect to CFR 49, the International Air Transport 

Association (IATA) regulations, and the UPS Dangerous Goods Agreement:

For non-medical, non-hazardous U.S. domestic air packages with 2.5 kg (5.5 pounds) or less of dry ice, mark 

the outer carton in the following way using in prominent one-inch block letters:

1. "Dry Ice" or "Carbon Dioxide, Solid"

2. If dry ice, then also "DRY ICE; 9; UN1845.”

3. A general description of the non-hazardous contents (for example, food, meat)

4. The amount of the dry ice contained in the package at the time of packaging, or a statement that there 

is 2.5 kg [5.5 pounds] or less in the package.

5. Use the dedicated Dry Ice Label (available from the carrier) (For an example, see IOM Exhibit 4-19).

Complete the bottom portion of the sticker and note the amount of dry ice in kilograms.

For non-medical U.S. domestic packages with greater than 2.5 kg (5.5 pounds) of dry ice:

1. Indicate in Campus Ship that you will be shipping dry ice or attach “Hazardous Materials” shipping papers 

available from the carrier (note that a $5 per package of dry ice fee applies).

2. The package must be prominently marked in one inch block letters as containing "Dry Ice" or "Carbon 

Dioxide, Solid", UN1845 (See: IOM Exhibit 4-19).

3. A label identifying dry ice contents is available from the carrier (for an example, see IOM Exhibit 4-19).

4. The net weight of dry ice at the time of packaging must be indicated on the shipping papers and can also 

be marked on the outer package prominently in one-inch block letters.

5. UPS Dangerous Goods Agreement is required here. A UPS “Dangerous Goods Agreement,” available from 

the shipper, is required to be filled out and provided to the shipper at time of shipment.
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Note: The dry ice may freeze the edges of the product, so if it is imperative that no part of the sample becomes 

frozen, use coolants other than dry ice. Mark the FDA 525 that dry ice was used.

See IOM 4.7.5.6 when shipping sample packages containing hazardous or toxic items by air.

4.7.3.5.2 – Control 

If it is necessary to ensure the shipment does not thaw in transit, place a jar or leak-proof plastic bag of 

chipped ice in the shipment adjacent to the sample package--but not within the officially sealed package. Be 

sure to note this approach on the C/R and ask the sample custodian to ensure that the ice remains frozen.

4.7.3.6 - Refrigerated (Not Frozen) Samples 

Maintain refrigerated (not frozen) samples in a refrigerator at 4.4oC (40oF) or below. Use either wet ice or some 

type of "Ice Pak," "Liquid Ice," "Sno-Gel," "Kool-It," or similar product to maintain the required temperature range.

Place Ice Paks, etc., in sealed plastic bags to protect samples from possible contamination, should the container 

break, the ice melt, or the refrigerant penetrate the sample. Use insulated shipping containers for shipping 

samples to the laboratory.

4.7.3.6.1 – Control 

If it is necessary to show the sample temperature did not go above the desired or specified temperature, you 

can use one of several methods, such as including a pre-chilled, shaken-down, maximum reading thermometer

or a commercially available indicators. Take care to place the thermometer outside of the sealed sample 

package and attempt to place in an area anticipated to be likely to reach the highest temperature. Describe 

the method used on your C/R.

4.7.4 - Official Seals 

Domestic samples (excluding DOC samples) should be sealed with form FDA 415a, Official Seal, or, in some situations 

with the FDA Metal Seal. See IOM 4.7.4.6 for use of metal seals. 

Note: With the approval of your supervisor and laboratory, it is not necessary to affix an official seal to a sample that 

will be in the sample collector's continuous personal custody until it is submitted personally to an analyst. This 

procedure should be reserved for emergencies and other high-priority situations. The sample should be submitted the 

same day it is collected with the subs properly identified. The C/R must state you personally delivered the sample to 

"Analyst ______" or other appropriate staff member.

Make every effort to prepare and submit or ship your samples on the date collected so that the C/R, sub identification, 

and the final official seal bear the same date, and thus enhance sample integrity. However, if you cannot finish sample 

preparation on the same day it was collected, you must explain in the C/R Collection Remarks field what steps you took 

to protect the integrity of the sample (for example, I sample was officially sealed and locked in supply cabinet, or 

locked in safe, etc.). If you cannot ship the same date as collected, you should at least complete identifying the subs 

and sealing the container on that day. In cases where subs need to be identified on the next day before shipping, use 

an Official Seal to seal the subs. On the next day, you can break and sign the seal. Explain in your regulatory notes and 

attach the broken seal to your C/R.

Never place more than one sample in the same officially sealed package. Large samples with numerous subs may be 

split into two or more containers with more than one official seal. When a 702(b) portion is collected, it is advisable to 

use at least two containers with one container containing only the 702(b) portion. Clearly identify the container 
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holding the 702(b) portion so that the lab analyst does not unintentionally break the seal and open that container. 

Separate official seals should be applied to each container.

Official seals may be used up to five years beyond the expiration date indicated by the manufacturer of the seal. Field 

offices should periodically monitor their official seal inventory and discard or destroy any official seals that are more 

than 5 years beyond the expiration date indicated by the manufacturer of the seal.

4.7.4.1 – Preparation of Official Seal 

Inscribe the FDA 415a, official seal, with the division office name, sample number (with the appropriate prefix), the 

date applied, and your signature, printed name, and title. See IOM Exhibit 4-17. The seal must bear only one 

signature. If more than one person is involved in collecting the sample, the person preparing and signing the 

collection record must sign the seal.

4.7.4.2 – Application 

Seal the sample package so that it cannot be opened at any point without evidence of tampering. If the surface of 

the sample container is of such construction or condition that the FDA-415a, official seal, will not adhere (for 

instance, container is a waxed container, frosted over, or sweating, etc.), then wrap or place the sample in a 

container to which the official seal will hold. See IOM 4.7.4.6.

To ensure the sample package cannot be opened at any point without evidence of tampering, wrap clear packing 

tape around the package that the seal is adhered to and across at least two sides of the official seal. The clear 

packing tape, however, should not cover any text on the official seal.

When using the self-adhering seals, the surface on which the seal is to be placed must be clean and dry. Note that 

the seal must also be rubbed when affixed to generate heat and help it bond.

4.7.4.3 - Sealing Method 

There are many acceptable methods of officially sealing samples. Because of the wide variety of shapes and sizes 

of samples, and the ingenuity you may have to apply to package and packaging situations, explicit methodology 

will not be detailed here. If you are unsure of a sealing method, consult your supervisor. 

4.7.4.4 - Protecting the Official Seal 

Protect the sealed surface by wrapping the package securely with heavy wrapping paper for mailing or shipment. If 

your officially sealed package is not further wrapped for shipping and the tape(s) and official seal are thus exposed, 

you must protect the official seal from damage during shipment by:

1. Covering the official seal with a sheet of heavy wrapping paper or heavy clear plastic (for example, like that

from a document protector) of sufficient size to cover the surface of the official seal.

2. Tape the protective paper or heavy clear plastic securely around the edges so it cannot come loose and 

expose the official seal. Do not paste or glue the paper or plastic to the face of the official seal since this 

will obliterate the official seal when removed. 

When you protect the official seal by heavy paper, write "FDA Seal Underneath," or similar wording across the 

protective paper. This alerts the receiving custodian that the official seal is underneath, and to take care when 

removing the protective paper. Contrastly, if you cover and protect the seal with heavy clear plastic, the sample

custodian will be able to copy the necessary information off the seal without removing the protective cover.
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4.7.4.5 - Broken Official Seals 

Reseal the sample if you should have to break the official seal. Each seal used on the sample must be submitted 

with the records associated with the collection record, properly initialed and dated, to provide a continuous 

history.

There is only one class of seal: an "official seal." Anytime a sample is sealed with the FDA 415a, or with the FDA 

Metal Seal, the item is "officially sealed." An officially sealed sample must sometimes be reopened to prepare it for 

submission to the laboratory, or for some other legitimate reason. In that situation, the original seal must show the 

date it was broken. When the sample is ready to be resealed, the new seal must show the date it is applied. This 

procedure must be followed each time the official seal on a sample is broken. Each seal will show the history of the 

date it was applied and broken. (See instructions in Exhibit 4-17). Indicate in the Collection Remarks field of the 

FACTS C/R the fact that the seal was broken and reapplied, and attach the broken seal to the FACTS C/R. This 

provides an unbroken, documented chain of custody.

4.7.4.6 - Metal Seals 

Where it is impossible to use the paper official seal, the numbered self-locking "U.S. Food and Drug" metal seal 

may be used. This seal is effective for use on wooden crates, drums, baskets, etc., where the FDA 415a cannot be 

used. Record the number of the metal seal used on the C/R. See IOM 4.3.3.3 for instructions on the use of the 

metal seal to reseal railroad cars or conveyances. When a supply of these seals is needed by your division, contact 

the Division of Domestic Human and Animal Food Operations (DDHAFO) at (301) 796-0360.

4.7.4.7 - Sealing Non-Sample Items 

Although the primary purpose of the official seal is for sealing samples, there are times when the official seal may 

be used to officially seal items other than samples. For instance, the FDA metal seal is often used to seal rail cars or 

vehicles, as indicated in IOM 4.3.3.3. 

When directed by your supervisor, you may use an official seal to seal questionable or suspicious bioresearch 

records encountered during an inspection or investigation to prevent their tampering or to preserve their integrity. 

As explained in the applicable compliance program, this procedure must have the approval of the bioresearch 

monitoring staff (HFC-230) prior to implementation.

4.7.5 - Sample Shipment 

ORA SOP-000178 covers all shipments made by ORA. 

The FDA collects a wide variety of samples, some of which may contain unstable, toxic, or hazardous 

materials (this includes etiological agents, radiation products, chemicals, hard swells, etc.). Therefore, 

use safety precautions in handling and shipping commensurate with the hazard. ORS provides 

guidance on shipping hazardous goods here: Shipping of Dangerous Goods (sharepoint.com). See also 

IOM 4.7.5.6. 

4.7.5.1 Preparing the box for shipping 

Place the words "SAMPLE NO” or “ENTRY NO” (in all caps)--followed by the appropriate FACTS or OASIS sample

number(s) (with appropriate prefix)--on the outside of the shipping package(s) near the address label. The 

package(s) should be properly identified with the FDA office that is shipping the sample and the laboratory or 
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other office receiving the sample. This alerts the receiving mail room that the package contains a sample and must 

go to the sample custodian.

Note that certain Department of Transportation (DOT) regulations exist pertaining to carrier inspection of 

packages. As such, be prepared to instruct the carrier to contact the shipper (FDA) prior to any package inspection 

that may require breaking the official seal. Carriers have been known to break official FDA seals during package 

inspection during transit, and have compromised sample integrity in the process. If an FDA 3082 - Shippers 

Declaration for Dangerous Goods is executed for shipments of restricted items, place a statement in the special 

handling section that breaking an FDA official seal is not authorized, and to contact the shipper (FDA) if there are 

any questions regarding the shipment. See IOM Exhibit 4-18.

4.7.5.2 - Method of Shipment 

When you cannot personally deliver a sample to the examining laboratory, ship it by the most economical means, 

commensurate with the need for rapid handling.

4.7.5.2.1 - USPS Shipments 

Before using the contract carrier, you should determine if using United States Parcel Post (USPS) is a more 

cost-efficient mode of shipping the sample. USPS should be used only for non-emergency, non-perishable

samples and when the package meets USPS limits. Details on shipping by USPS can be found at How to Prepare 

& Send a Package | USPS. The same webpage can be used for scheduling a pick-up too. 

4.7.5.2.2 – Contract Carrier Shipments 

The FDA contracts with a carrier for almost all shipments. You should use the contract carrier whenever 

possible. (SOP-000178 provides guidance for using the contract carrier to ship samples.) 

4.7.5.2.3 – Use of other Shippers for Samples 

When the contract carrier cannot deliver the sample in time for the laboratory to conduct the analysis, then 

discuss with your supervisor other appropriate methods for shipping the sample. For example, if the contract 

carrier cannot guarantee overnight delivery in the morning for a sample collected during an outbreak, then use 

of another carrier may be permitted.

4.7.5.3 - FDA 525 - Sample Package Identification 

Form FDA 525 - Place the FDA 525, sample package identification, near the official seal. Do not affix the FDA 525 

on the outside of the shipping container or under the official seal. Provide the following information on the FDA 

525:

1. Division or Headquarters' laboratory to which the sample is directed, City, State, and unit symbol (e.g., SRL, 

HFD-400, HFS-300, etc.).

2. Date.

3. Your division and symbol.

4. Sample or Entry Number.

5. Name of dealer.

6. Product Identification.

7. Address of dealer.

8. Enter the reason for collection. (Copy from C/R.) Provide reference to any sampling assignment.

9. Provide information regarding the analysis to be made. 
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10. The Assignment Number and Name if sample was collected as part of an Assignment

11. When entering information for "Package___of___Packages," the number of packages should be the 

number of sample packages. Also enter any pertinent remarks. Also note if your division desires the return 

of any freezer chests, ice packs, or maximum/minimum thermometers used.

12. Provide any relevant special storage instructions. Mark the appropriate block and enter the suggested 

refrigeration temperature, if necessary. Elaborate in Remarks, if necessary, too.

13. Print your name.

14. See IOM 4.7.3.4 when using the FDA 525 as a sample package. 

Outer Wrapper or shipping container - Always place the words, "SAMPLE NO. ________" followed by the actual 

FACTS or OASIS sample number(s) (with appropriate prefix) on the outside of the package near the address label. 

This alerts the receiving mail room that the package contains a sample and must go to the sample custodian.

4.7.5.4 - Routing of Samples 

In general, samples will be submitted to an appropriate servicing laboratory with available capacity via the Lab 

Servicing Table (LST) Dashboard, except as directed by the Compliance Program Guidance Manual, assignment, or 

your supervisor. 

4.7.5.4.1 - Samples to Administration Laboratories 

When shipping samples to headquarters or other special laboratories, follow the procedures for each 

laboratory found in Exhibit 24.

4.7.5.4.1.1 - Split Samples 

In instances where the sample examination duty is split between a Headquarters Division of the National 

Center for Drug Analysis, and an ORA laboratory then you should follow the directions noted in Exhibit 24. 

Also, submit the Original C/R and records to the servicing laboratory, whether or not it is affiliated with the 

home division. 

4.7.5.4.2 - Sample Shipment to Outside Agencies 

Do not ship any samples outside the FDA unless your assignment, applicable program, or your supervisor 

specifically instructs you to do so.

4.7.5.5- Notifying Receiving Laboratories 

When frozen, perishable, or high priority items are shipped, notify the receiving division or lab by telephone, or 

email, that you have shipped the sample. Be sure to provide all of the following information:

1. Sample Number.

2. Name of Product.

3. Number of Parcels in Shipment.

4. Carrier's Name.

5. Carrier's Waybill or Tracking Number.

6. Carrier's Train, Truck, Bus, or Flight Number.

7. Estimated Time and Date of Arrival.
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8. Relevant Remarks (for instance, "Sufficient Dry Ice provided to maintain frozen until approx. 8:00 a.m., 

(date)").

9. Place the name and telephone number of the person that is to receive the sample on the outer shipping 

container near the address, with instructions to the carrier to contact the above-named individual upon 

arrival of the package.

4.7.5.6 - Shipment of Hazardous or Toxic Items 

The Department of Transportation (DOT) regulations require certain packaging, forms, 

certifications, declarations, and/or statements covering shipment of hazardous or toxic items. 

Except for dry ice, most of the samples of hazardous or toxic materials that the FDA ships are 

classified as "ORM-D, Consumer commodity." Both dry ice classified as "9", and ORM-D 

classifications require a certification/declaration for shipment by air, but not for shipment by 

surface transportation.

For shipments containing dry ice, use the dedicated Dry Ice Label (available from the carrier - for an example see 

IOM Exhibit 4-19). Complete the bottom portion of the sticker and note the amount of dry ice in kilograms. In 

addition to the label, the package itself must be clearly marked in one-inch block letters, as in, "DRY ICE; 9; 

UN1845".

Contact the carrier involved to execute the necessary forms, certification/declarations, packaging, marking, etc., 

required for the particular shipment or for hazardous or toxic items.

For further information, contact your district Safety Officer or Industrial Hygienist. 

4.7.5.7 – Additional Precautions When Shipping Samples 

The following precautions should be observed when shipping samples:

1. Always pack liquid products in sufficient cushioning and absorbent material to absorb any breakage that

might occur. Check with USPS or other carriers regarding shipment of liquids.

2. Hard swells may explode. Wrap them heavily in paper and cushioning material for shipment and submit 

promptly.

3. Observe special precautions when shipping products in pressurized containers to avoid exposure to

excessive heat. Air shippers that ship in non-pressurized planes may also have special requirements for this 

type of container. Check USPS or other carrier for regulations, precautions, or restrictions before shipping 

products in this type of container.

4. Special precautions for both packaging and shipping radioactive substances must be observed. If 

necessary, consult your supervisor, the FDA radiological health representative, WEAC, or the applicable 

program.

Note: The compliance program for radioactive drugs directs the manufacturer to ship samples via their 

normal mode of transportation to WEAC. The Nuclear Regulatory Commission (NRC) requires that firms 

manufacturing radioactive drugs ship only to NRC-licensed consignees. WEAC's NRC license number is 20-

08361-01 with Exp. Date 11/30/2026. This license number should be used for any shipments of radioactive 

products to WEAC.
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4-1- FACTS SAMPLE COLLECTION SCREEN 
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EXHIBIT 4-1 INVESTIGATIONS OPERATIONS MANUAL 2023

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EXHIBIT 4-2 INVESTIGATIONS OPERATIONS MANUAL 2023

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4-2 FACTS SAMPLE COLLECTION SCREEN 
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 4-3

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4-3 AFFIDAVIT (IN-TRANSIT)- FDA 1664b 
EXHIBIT 4-4 INVESTIGATIONS OPERATIONS MANUAL 2023

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4-4 CARRIER’S RECEIPT FOR SAMPLE – FDA 472 
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4-5 – INSTRUCTIONS FOR COMPLETEING THE FDA 484, RECEIPT FOR SAMPLES 

Block 1 - Enter your Division address and telephone number including area code. 

Block 2 – Enter the complete name and official title of the individual to who you issue the 

FDA 484.

Block 3 – Enter the date the form was issued. If this differs from the sample collection 

date (for example in the case of environmental sampling), enter the collection date(s)

in Block 9.

Block 4 – Enter the complete sample number here. Be sure to include any prefixes such as 

“DI” or “INV”.

Block 5 – Enter the firm’s legal name. This should be the firms legal name and not the DBA 

(doing business as), trade name, or alias. 

Block 6 – If the firm is a dealer in narcotics or controlled drugs, enter their Drug Enforcement 

Administration (DEA) number here. 

Block 7 and 8 – Enter the number, street, city, state, and zip code of the firm. 

Block 9 – Enter a brief description of the article collected, including the number and size of 

units collected, product name, any identifying brand and code marks, and date(s) collected. 

Block 10 – Check the appropriate box on the FDA 484.

Block 11 – Enter the amount paid for the sample (even if borrowed, the owner may ask rent 

for it) and check the appropriate box. If there is no charge, enter N/C and leave boxes blank. 

If, as a last resort, it is necessary for you to use your personal check or credit card and this is 

acceptable to the individual, enter amount and check the “Credit Card” box. 

Block 12 – In instances where payment is made for the sample, whether actually purchased, 

borrowed or provided at no charge, and there is no dealer’s affidavit, or any other document 

executed to show the owner’s signature for receipt of payment, obtain the signature of the 

individual receiving payment for the sample. 

If Dealer's Affidavit, regular Affidavit or other document is used, the recipient's signature will 

be on that document, so it is not necessary for him to also sign the FDA 484. In this case 

insert an applicable statement such as "Dealers Affidavit signed" in this block.

Blocks 13, 14, and 15 – Enter your name, title, and signature. 
EXHIBIT 4-5 INVESTIGATIONS OPERATIONS MANUAL 2023

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INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 4-5

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EXHIBIT 4-6 INVESTIGATIONS OPERATIONS MANUAL 2023

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4-6 – FIELD WEIGHT SHEET – FDA 485 
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 4-7

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4-7 – AFFIDAVIT – “301(k) Sample” – FDA 463a 
EXHIBIT 4-8 INVESTIGATIONS OPERATIONS MANUAL 2023 

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4-8 – COPY OF INVOICE/SHIPPING RECORD – FD 1662 1. LOCATION 

Pine Bluff, Arkansas

2. NAME OF SAMPLE COLLECTOR 

Sylvia H. Rogers

3. DATE COLLECTED 

10-8-05

4. SAMPLE NUMBER 

55566

SECTION I - COPY OF INVOICE

5. CONSIGNOR (Name, Street, City, and State)

Captain Sam Seafood, Inc. 

719 Butler Ave. 

New Orleans, LA

6. CONSIGNEE (Name, Street, City, and State)

Razor Back Super Market 

1207 Little Rock Dr. 

Pine Bluff, AR

7. GUARANTEE 

-----see reverse-----

8. INVOICE NUMBER 

477

9. INVOICE DATE 

9-20-05

10

QUANTITY

11

UNIT SIZE

12

DESCRIPTION OF ARTICLE(S)

13

UNIT PRICE

14

TOTAL

10 cs. 24/4.5 oz. Horseshoe Brand Canned Medium Shrimp 2 84 56 80

5 cs. 10/5 lb. Frozen Green Hills 21-25 Shrimp 1 10 275 00

***************************

5cs. 24/8 oz. Horseshoe Brand Canned Cove Oysters 5 25 52 50

****************************

2 cs. 6/4 lb. Frozen C&P Small Shrimp 1 50 72 00

15. TOTAL 642 80

SECTION II - COPY OF SHIPPING RECORD

16. SHIPPER (Name, Street,, City, and State)

Captain Sam Seafood, Inc. 

NOLA

17. CONSIGNEE (Name, Street, City, and State)

Razor Back Super Market 

1207 Little Rock Dr. 

Pine bluff, AR

18. CARRIER (Name, City, and State)

Sea Breeze Trucking, Inc. NOLA

19. CAR OR EQUIPMENT NUMBER

Van 109

20. WAYBILL DATE & NUMBER 

N/A

21. TYPE OF RECORD (Specify)

F/B

22. RECORD NO. 

06641

23. RECORD DATE 

9-20-05

24. SHIPPED FROM (City and State)

NOLA

25. ROUTE 

N/A

26. DATE SHIPPED 

9-20-05 27

DESCRIPTION OF ARTICLE(S)

28

NO. PKGS.

29

WEIGHT

30

RATE

31

CHANGES

Canned Food 20 300 172 5.16

Frozen Seafood 8 350 224 7.84

32. RECEIVED BY 

P. Monteux s/s

33. DATE REC’D 

9-26-05

34.

TOTAL

28 650 13.00
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4-9 AFFIDAVIT (PARCEL POST) – FDA 463a 
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4-10 - AFFIDAVIT – FDA 463a 
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4-11 – AFFADAVIT – FDA 463a 
EXHIBIT 4-12 INVESTIGATIONS OPERATIONS MANUAL 2023

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4-12 – AFFIDAVIT – (Dealer/Warehouseman) – FDA 1664 
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 4-13

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4-13 – AFFIDAVIT – FDA 463a 
EXHIBIT 4-14 INVESTIGATIONS OPERATIONS MANUAL 2023

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4-14 – AFFIDAVIT – (Jobber) – FDA 1664a 
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4-15 FACTS SAMPLE COLLECTION SCREEN 
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4-16 FACTS SAMPLE COLLECTION SCREEN 
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 4-16 

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EXHIBIT 4-17 INVESTIGATIONS OPERATIONS MANUAL 2023

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4-17 OFFICAL SEAL – FDA 415a 
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 4-18

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4-18 DECLARATION FOR DANGEROUS GOODS 
EXHIBIT 4-19 INVESTIGATIONS OPERATIONS MANUAL 2023

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4-19 DRY ICE LABEL 
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 4-20 

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4-20 Environmental Sampling for Detection of Listeria monocytogenes, CFSAN Guidance 

BACKGROUND 

Listeria monocytogenes has been associated with such foods as raw milk, supposedly pasteurized fluid milk, cheeses (particularly 

soft-ripened varieties), ice cream, raw vegetables, fermented raw-meat sausages, raw and cooked poultry, raw meats (all types), 

and raw and smoked fish. Its ability to grow at temperatures as low as 0°C permits multiplication in refrigerated foods.4 Listeriosis is 

a foodborne illness of major public health concern because of the severity of the disease (meningitis, septicemia, and pregnancy 

complications such as miscarriage or stillbirth), a high case-fatality rate, and a long incubation period. Listeria monocytogenes differs 

from most other food-borne pathogens because it is widely distributed, resistant to diverse environmental conditions, including low 

pH and high NaCl concentrations, and is microaerobic. The multitude of ways it can easily enter food processing plants and its ability 

to grow and survive for long periods of time (in the environment, in/on foods, and in food processing plants) under adverse 

conditions have made it a major concern for many manufacturing industries in recent decades.2

SAMPLE COLLECTION

DO Collect Samples From: DON’T Collect Samples From:

Moist/wet areas with standing water Dry, clean areas

Direct food contact surfaces Employees – work shoes, hands etc.

Floors and related areas – Under floor mounted equipment, 

scales (floor and table mounted)

Hand wash or eyewash stations 

Sanitizing foot mats – if disinfectant is not maintained this can 

be a good harboring source and point of transfer to 

other areas of the facility

Packaging materials – jars, lids, etc.

Cleaning Equipment – automated floor cleaning equipment, 

brooms, mops, waste containers especially underside, 

etc.

Raw agricultural products – raw peanuts etc. or any food contact surface 

used exclusively for raw foods.

Air conveying equipment – pressurized air lines, air hoses, 

condensate from pressurized air lines, HVAC 

evaporators and evaporator condensate pans

Outside the plant – roof, parking lot, walkways, etc.

Product conveyors – cables, belts, joints, where product 

residue accumulates, exposed bearings and rollers, 

sponge or felt rollers used to remove moisture from 

product

Zone 4

Motor and Electrical Housings – that are not cleaned and/ or 

sanitized.

Cracked equipment – boots (shock absorbing equipment), 

metal joints, etc.

Under sinks / safety stations – Under hand wash or eyewash 

stations if appearance of leaks, cracks, etc.

Equipment – areas that are difficult to reach and clean, nonfood contact surfaces, nooks, and crannies.

Doorways - floor area leading directly into production areas

Drains – Not during production

Ice Makers – inside, scoops, underside of top of ice chamber

Ceilings and Walls – in production areas coolers and freezers 

Door gaskets to coolers and freezers; damp insulation around 

pipes

References:

1. FDA. Investigations Operations Manual 2008. 4.3.7.7 – Environmental Sampling

2. Doyle, Michael et al. Food Microbiology Fundamentals and Frontiers 2nd Ed. Pgs. 383-403.

3. Cliver, Dean and Riemann, Hanns. Foodborne Diseases 2nd Ed. Pgs. 55 – 67

4. Bad Bug Book. Listeria monocytogenes, Page 100

5. Control of Listeria monocytogenes in Refrigerated or Frozen Ready to Eat Foods Draft Guidance. 

6.
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4-21 Environmental Sampling for Detection of Salmonellae, CFSAN Guidance 

BACKGROUND

Salmonellosis has been known to be a food-borne disease since the late 1800s. It still remains a major food safety

concern throughout the world, is the major cause of bacterial foodborne illness in the U.S and is a pathogen of significant 

interest to FDA. The major reservoirs for Salmonellae are raw meats, poultry, and eggs; the organism is also isolated 

from aquaculture products and fruits, vegetable, and nut meats. Salmonellosis outbreaks have been associated with a 

variety of foods, including raw seafood, fresh produce, egg products, cake mixes, unpasteurized milk, peanut butter, 

chocolate, and salad dressings. Salmonellae are known to survive and grow in the natural environment, including water

sources. It is ubiquitous and has been recovered from some insects and nearly all vertebrates and invertebrates. This 

makes the recovery and identification of Salmonellae critical as an environmental contaminant.

SAMPLE COLLECTION

DO Collect Samples From: DON’T Collect Samples From:

Floors and related areas – Under floor mounted 

equipment, scales (floor and table 

mounted)

Employees – work shoes, hands etc.

Sanitizing foot mats – if dry Hand wash or eyewash stations 

Cleaning Equipment – central vacuum systems, 

automated floor cleaning equipment 

(e.g., Tenent type walk-behind or riding 

sweepers, brooms, mops, etc.) Pay 

particular attention to the collection of 

floor sweepings or the dry contents of 

vacuum cleaner bags or tanks.

Packaging materials – jars, lids, etc.

Air conveying equipment – air filters; air ducts 

and intake and exhaust vents; food 

residue on equipment and floors if old 

and dry

Direct food contact surfaces –cleaned often, 

would be unlikely to have residual 

organism growth. 

Product conveyors – cables, belts, joints, where 

product residue accumulates, if the 

residue is old and dry

Raw ingredients– raw peanuts refined sugar, 

etc.

Unsealed control and drive chambers; 

electrical/ mechanical service boxes that 

are not cleaned and/ or sanitized. Look 

for dry dust and residue in these boxes.

Outside the plant – roof, parking lot, etc.

Cracked equipment – boots (shock absorbing 

equipment), metal joints, etc.

Areas with running water and very wet areas

Under sinks / safety stations – Under hand 

wash or eyewash stations if appearance 

of leaks, cracks etc.

Zone 4
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References:

1.FDA. Investigations Operations Manual 2008. 4.3.7.7 – Environmental Sampling

2. Doyle, Michael et al. Food Microbiology Fundamentals and Frontiers 2nd Ed. Pgs. 141-178.

Cliver, Dean and Riemann, Hanns. Foodborne Diseases 2nd Ed. Pgs. 55 – 67

Equipment – areas that are difficult to reach 

and clean, non-food contact surfaces, 

nooks, and crannies if dry.

Doorways - floor area in doorways leading into 

or out of the production facility or onto 

the roof

Pallets – Floor under wooden or plastic pallets 

and pallets themselves

Floor drains - use a sponge to scrub dry residue 

from floor drain grids and walls
SAMPLE SCHEDULE CHART 1 INVESTIGATIONS OPERATIONS MANUAL 2023

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1- SALMONELLA SAMPLING PLAN 

PURPOSE:

To determine the presence of Salmonella in processed foods and soils/water used for the growth of foods intended for 

human consumption.

APPLICABILITY:

This sampling plan is applicable to the inspection of either a continuing series of production lots or to isolated lots 

consisting of an identifiable collection of process units (cans, bags, packages, or similar units). Additionally, the soil plan 

is for use during on-farm investigations requiring the sampling of soil for the presence of Salmonella. This plan is for use

by FDA for regulatory purposes.

FOOD CATEGORIES:

Foods are listed in three categories based on the number of Salmonella hazards and whether a food is to be consumed 

by infants, the aged, or infirm.

The three defined Salmonella Hazards of foods are:

1. The food or an ingredient of the food is a significant potential source of Salmonella;

2. The manufacturing process does not include a controlled step that destroys Salmonella; and

3. The food has significant potential for microbiological growth if "abused" in distribution or by consumers.

Classification of Foods:

Foods have been classified into three food Categories for regulatory sampling purposes. The foods are listed in the 

Categories by Product Code sequence.

NOTE: For imported seafood products, see CPGM 7303.844

NOTE: For products not listed, check with your supervisor. The Division will request categorization from the Office of 

Field Programs/Center for Food Safety and Applied Nutrition (HFS-600), or, when time is of essence, the Division will 

make the categorization and obtain later concurrence from CFSAN.

Category I

This includes all foods that would normally be in Category II except that they are intended for consumption by the aged, 

the infirm, and infants.

Category II

This includes the foods that would not normally be subjected to a process lethal to Salmonella between the time of 

sampling and consumption. Examples are as follows:

PRODUCT 

CODE FOOD ITEM
INVESTIGATIONS OPERATIONS MANUAL 2023 SAMPLE SCHEDULE CHART 1

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03 Bread, rolls, buns, sugared breads, crackers, custard, and 

cream filled sweet goods

05 Breakfast cereals, ready to eat

07 Pretzels, chips, and specialty items

09 Butter and butter products; pasteurized milk and raw fluid 

milk and fluid milk products for consumption; pasteurized 

and unpasteurized concentrated liquid milk products for 

consumption; dried milk and dried milk products for 

consumption

12 Cheese and Cheese products

13 Ice cream from pasteurized milk and related products that 

have been pasteurized; raw ice cream mix and related 

unpasteurized products for consumption.

14 Pasteurized and unpasteurized imitation dairy products 

for consumption

15 Pasteurized eggs, egg products from pasteurized eggs; 

unpasteurized eggs and egg products from unpasteurized 

eggs for consumption without further cooking

16 Cured fish, vertebrates; other fish products; fresh and 

frozen raw oysters and raw clams, shellfish, and 

crustacean products; smoked fish, shellfish, and 

crustaceans for consumption

17 Unflavored gelatin

20-22 Fresh, frozen, and canned fruits and juices, concentrates 

and nectars; dried fruit for consumption; jams, jellies, 

preserves and butters

23 Nuts and nut products for consumption

26 Oils consumed directly without further processing and 

oleomargarine

27 Dressings and condiments (including mayonnaise) salad 

dressing and vinegar

28 Spices including salt; flavors and extracts

29 Soft drinks and water

30 Beverage bases

31 Coffee and tea 

33 Chewing gum and candy

34 Chocolate and cocoa products

35 Pudding mixes not cooked prior to consumption, gelatin 

products

36 Syrups, sugars, and honey

38 Soups

39 Prepared salads

Category III 

This includes the following foods that would normally be subjected to a process lethal to Salmonella between the time 

of sampling and consumption. Examples are as follows:

PRODUCT 

CODE FOOD ITEM
SAMPLE SCHEDULE CHART 1 INVESTIGATIONS OPERATIONS MANUAL 2023

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02 Whole grain, processed grain, and starch products for 

human use

04 Macaroni and noodle products

16

Fresh and frozen fish; vertebrates (except that eaten raw); 

fresh and frozen shellfish and crustaceans (except raw 

oysters and raw clams for consumption); other aquatic 

animals (including frog legs)

24

Fresh vegetables, frozen vegetables, dried vegetables, 

cured and processed vegetable products normally cooked 

before consumption

26 Vegetable oils, oil stock and vegetable shortening

35 Dry dessert and pudding mixes that are cooked prior to 

consumption

37 Frozen dinners, multiple food dinners

45-46 Food chemicals (direct additives)

SAMPLE COLLECTION

Each sub will consist of a minimum of 100 g (approx. 3.53 oz). The usual subsample is a consumer size container of a 

product. Subsamples should be obtained at random to ensure that the total sample is representative of the lot. When a 

lot consists of identifiable subsamples (e.g., different codes), sub samples should be obtained from subsamples in the 

proportion that the subsamples are to the whole lot.

More than one subsample may be collected from large institutional or bulk containers when the number of sub samples 

required exceeds the number of containers in the lot. A subsample will consist of more than one container when the lot

consists of containers smaller than 100 g (e.g., 4 - 25 g containers is a subsample).

When a sample is collected by transferring it to sample containers, a sample control must be submitted which consists 

of an empty sample container that is exposed to the same conditions under which the sample is collected. See IOM 

4.3.6.2 and 4.3.6.5 on controls. Use aseptic technique when sampling from bulk containers.

SAMPLE SIZE

The following sample sizes also apply to the finished product portion of in-line samples when analyzed for Salmonella. 

Each subsample will consist of at least 100 gm (approx. 3.5 oz).

The 702(b) [21 U.S.C. 372(b)] portion is included in these subsamples; however, all subs must be collected for proper 

analysis. Do not reduce the number of subsamples when collecting import samples.

FOOD NUMBER OF SAMPLE 

CATEGORY UNITS (SUBS)

 I 60

II 30

III 15

SAMPLE SUBMISSION 

Submit all samples collected to your division's microbiological servicing laboratory unless directed otherwise by your 

supervisor or assignment. See IOM 4.5.5.2.
INVESTIGATIONS OPERATIONS MANUAL 2023 SAMPLE SCHEDULE CHART 1

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FARM INVESTIGATIONS – SOIL AND WATER SAMPLES

Soil Samples

When conducting an investigation at a farm that was implicated as the source of produce contaminated 

with Salmonella, and the crop is exposed to soil or water splash from the soil, such as leafy greens, cantaloupes, or 

cucumbers, soil samples may yield important information as to how the produce was contaminated, especially if a soil 

amendment such as animal manure or compost was used, or if the crops on that field were rotated and animals grazed 

on the land previously.

Unless specific instructions were provided by the office issuing the assignment, generally 5 sub samples are collected 

per field, one from the growing area on each corner, and one near the center. Additional samples may be collected 

based on observations, such as animal incursion, areas where water may drain, portions of the field susceptible to road 

dust or runoff, etc. Each field should be issued a separate sample number for ease of identification and review of data. 

A 1000 ml whirlpack should be filled with soil from a depth of 1 to 3 inches using a sterile scoop and double 

bagged. Take a photograph of each area where samples are collected and indicate the location and subsample

number on a diagram of the field. 

Soil samples should be submitted to the lab at 4°C (39°F) or below.

Water Samples

If specialized equipment such as a peristaltic pump are not available, collect water in a sterile, 1000 ml Nalgene sample

bottle from wells and surface water. When collecting a surface water sample, a sterile pipette with a re-usable suction 

bulb is recommended. Using the end of the pipette, stir the surface of the sediment until the water becomes cloudy 

and then collect this water. Salmonella may form a biofilm or colonize sediments and be recovered well past the 

outbreak period.

Water samples should be submitted to the lab at 4 °C (39 °F) or below.

Environmental samples will be submitted as Investigational Samples (INV).
SAMPLE SCHEDULE CHART 1 INVESTIGATIONS OPERATIONS MANUAL 2023

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2- SAMPLING SCHEDULE FOR LOW-ACID CANNED AND ACIDIFIED FOODS 

Low Acid Canned Foods

Field Examination

1. At the beginning of the inspection, conduct visual exams of warehouse stock/product offered for import for evidence

of abnormal cans including swollen and leaking cans, wet cases, swarms of fruit flies around isolated pallets, etc. 

2. If the visual exam or inspectional evidence indicates possible problems, such as under processed lots, lots with 

questionable seam integrity, or abnormal cans, exam the affected lots. Preferably field examine lots that have been 

warehoused at least 14 days. 

3. A lot to be examined will be one production code. 

4. Follow the chart below for the field examination. If abnormal containers are found, always collect an 

official sample of the lot, if possible. For lots with abnormal cans collect an investigational sample ONLY when there 

is not enough product available to collect an official sample. In all cases, include on the collection report: the lot size, 

the number of containers examined, and the number of abnormal containers found by type (e.g., hard swells).

5. The chart provides instructions on the number of cans/cases to examine depending on the size of the lot. When the 

maximum number of containers / cases have been examined for the specified lot size, collect a sample if one or 

more abnormal containers are found. The exam can be discontinued early based on the number of abnormal 

containers found. For example, if examining a lot consisting of 3409 or more cans, if 11 abnormal cans are found 

after examining 1000 cans, discontinue the exam and collect a sample

a. Flippers. Only one end is slack or slightly bulged and the end remains flat if pressed in. Cans which bulge when 

sharply and squarely struck end-down on a flat surface are flippers, provided that the bulged end remains flat 

when pressed. Flippers result from a lack of vacuum.

b. Springers. One end of a can bulges. Manual pressure on the bulged end forces the opposite end out or the 

same end will spring out with release of pressure. If both ends bulge, but only one will remain flat when 

pressed, the can is a springer. Springers result from moderate positive pressure in the can. Buckling or 

extensive denting of the side wall may produce a springer. 

c. Swells. Both ends of the can are bulged. Neither end will remain flat without pressure. Soft swells yield to 

manual pressure, but no impression can

be made manually on hard swells. Swells result from positive pressure in the can usually because of spoilage of 

the contents. Some swells, especially in acid products, may result from chemical reaction between the 

contents and the container. 

NOTE: Other abnormalities or defects, such as visibly leaking cans, severe dents around seams, gross seam defects, 

severely rusted containers should be reported on C/R, (with numbers of cans defective cans observed) but not counted 

as "abnormal containers" for the purposes of the sequential field examination. Do not collect leakers, but report the 

number observed. It may be necessary to collect samples of other defects (e.g., seam defects) to support observations 

and document the severity of the defects. In some cases, photographs may be a suitable substitute for collection of 

physical samples. 

If a sample is collected, identify on the C/R, by sub-sample number, the condition of each container in the sample (e.g., 

sub-sample 1 - flipper; sub-sample 2 - hard swell; - sub-sample x - normal). Report the results of the warehouse stock 

examination in the EIR and in FACTS. See IOM 5.1.5.3

Special Sample Handling: If you are shipping swollen cans, double bag, and ground ship the sample. If the cans are 

moderately swollen or worse, you should ship the sample with ice packs.

When the 'Reason for Collection' on the Collection Report includes can seam analysis, the CSO shall collect the can 

seam specifications for the cans in the sample. This is specific to the can manufacturer and can size collected in the 
INVESTIGATIONS OPERATIONS MANUAL 2023 SAMPLE SCHEDULE CHART 1

4-127

sample. The can seam specifications will be submitted in the FD-525 along with the Collection Report for the servicing 

laboratory.

PACKED 48/CASE PACKED 24/CASE PACKED 12/CASE PACKED 6/CASE *Number Abnormal

Containers to 

Discontinue 

Examination Early

Lot Size 

Contain

Number to 

Examine

Lot Size

(Cases)

Cases to 

Examine

Lot Size 

(Cases)

Cases to 

Examine

Lot Size 

(Cases)

Cases to 

Examine

Lot Size 

(Cases)

Cases to 

Examine

192 or less All 1 - 4 all 1 - 8 All 1 - 16 All 1 - 32 all 3

193 - 288 192 4 - 6 4 8 - 12 8 16 - 24 16 32 - 48 32 5

289 - 384 all for< 298 

298 if greater

6 - 8 6 12 - 16 12 24 - 32 25 48 - 64

all < 50

50 if 

greater

6 

385 - 576 363 8 - 12 8 16 -24 15 32 - 48 30 64 - 96 61 7

577 - 912 433 12 - 19 9 24 - 38 18 48 - 76 36 96 - 152 72 8

913 - 1488 480 19 - 31 10 38 - 62 20 76 - 124 40 152 - 248 80 9

1489 - 3408 529 31 - 71 11 62 - 142 22 124 - 284 44 248 - 568 88 10

3409 or more 576 71 or 

more 12 142 or more 24 284 or more 48 568 or more 96 11 

1. Sample Size for Samples Collected as a Result of a Field Exam:

a. Official Sample

The sample will consist of all abnormal containers and the number of normal cans specified under “2. Official 

Samples” below (e.g., if 8 abnormal containers are observed during the examination of a lot containing 696/ 2 lb. 

cans the sample will consist of the 8 abnormal cans and 48 normal cans, collected 2 cans from each of 24 cases). 

Open additional cases, if necessary to meet this requirement. This will provide enough product for complete 

analysis, including: can seam, incubation, aerobic and anaerobic growth, pH and water. Note that the sample 

size given for normal cans includes the 702(b) portion.

b. Investigational Sample and Import Sample.

Samples for laboratory examination will consist of all abnormal and 12 normal containers. 

2. Other Sampling

Official Samples 

a. Filth, Micro, etc. (Includes 702(b) [21U.S.C.372 (b)] portion)

Collect each subsample to duplicate from a separate case, if possible. Mark subs 1a, 1b, 2a, 2b, etc. Collect as follows: 

NET WEIGHT SIZE OF LOT MIN TOTAL 

CANS CANS/CASE

795 gr (28 oz) 

and smaller

Up to 50 cases 48 2 from 24

More than 50 

cases 96 2 from 48

Over 795 gr (28 

oz)

Up to 600 cases 48 2 from 24

More than 600 

cases 72 2 from 36

b. Standards Assay (Includes 702(b) portion)

NOTE: Sample sizes listed below are based upon the requirements of the Standards (21 CFR 145.3). When 

sampling products which are likely to be non-uniform throughout the lot because of variations from standards 
SAMPLE SCHEDULE CHART 1 INVESTIGATIONS OPERATIONS MANUAL 2023

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of quality, identity, fill-of-container, grade, etc., collect each subsample in triplicate from a separate case. Mark 

subs 1a, 1b, 1c, 2a, 2b, 2c, etc. Collect as follows:

NET WEIGHT NUMBER OF CANS OR 

PACKAGES

MIN TOTAL 

CANS

CANS/CASE

1 kg (2.2 lbs.) 

or less 

4800 or less 48 3 from 16 

4801 to 24,000 72 3 from 24 

24,001 to 48,000 96 3 from 32 

48,001 to 84,000 144 3 from 48 

84,001 to 144,000 264 3 from 88 

144,001 to 240,000 384 3 from 128 

Over 240,000 600 3 from 200 

Greater than 

1 kg (2.2lbs), 

but less than 

4.5 kg (10 

lbs.) 

2400 or less 48 3 from 16 

2401 to 15000 72 3 from 24 

15001 to 24000 96 3 from 32 

24001 to 42000 144 3 from 48 

42001 to 72000 252 3 from 88 

72001 to 120,000 384 3 from 128 

Over 120,000 600 3 from 200 

Greater than 

4.5 kg (10 

lbs.) 

600 or less 48 3 from 16 

601 to 2000 72 3 from 24 

2001 to 7200 96 3 from 32 

7201 to 15000 144 3 from 48 

15001 to 24000 252 3 from 88 

24001 to 42000 384 3 from 128 

Over 42000 600 3 from 200 

Acidified Foods 

A lot is defined as one production code. 

Field Examination
INVESTIGATIONS OPERATIONS MANUAL 2023 SAMPLE SCHEDULE CHART 1

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Conduct a reconciliation examination and check for damaged or destructive container closures. For example, during a 

visual examination the following may be observed: 1) glass containers with obvious closure defects such as excessive 

torque on the lid and/or insufficient security, 2) plastic and semi-rigid containers with obvious defects such as leakers 

and poorly sealed lids, or 3) metal containers with damage or obvious container defects to the double seam.

Conduct a field examination if abnormal containers are observed during the reconciliation examination. Follow the 

applicable instructions provided above (see Low-Acid Canned Food “Field Examination” section, including chart) when 

performing a field examination.

Sample Collection

For acidified products, the equilibrium pH determines whether the product will support organisms of public health 

significance. Spoilage in such products is usually due to inadequate heat treatment to kill spoilage organisms. Spoilage 

may be significant because high numbers of microorganisms may affect the adequacy of the thermal process. Molds 

and some bacteria can grow in an acid environment and actually utilize acid as one of their nutrients; and thus, raise 

the pH to a level above 4.6 where Clostridium botulinum or other toxin-producing microorganisms can grow. 

Microbial spoilage can be detected by observing swollen lids on jars or swollen can ends. The liquid may be turbid, and 

a whitish deposit may be visible on the product or in the bottom of the jar. See the Guide to Inspection of Acidified 

Food Manufacturers for additional information: http://www.fda.gov/ora/inspect_ref/igs/iglist.htmlCollect samples for 

pH testing. Samples must be collected randomly from the entire lot. Sample size does not include 702(b) portion. 

1. # 10 cans – Use the following sample size for containers larger than 795 gr (28 oz): Randomly select 1 normal 

container from each of 12 randomly selected cases (if available) in the lot. Sample size is 12 containers.

2. # 2 half (1/2) cans – Use the following sample size for containers equal to 795 gr (28 oz) or smaller: Randomly 

select 2 normal containers from each of 12 randomly selected cases (if available) in the lot. Sample size is 24 

containers. 

If abnormal containers are encountered, collect all abnormal containers (up to a maximum of 24) in addition to the 

normal containers collected for pH testing (referenced above). Indicate on the C/R the total number of containers 

examined, and the number of each type of abnormality and defect observed. Also indicate the estimated percentage 

of abnormal containers in the lot. 
SAMPLE SCHEDULE CHART 3 INVESTIGATIONS OPERATIONS MANUAL 2023

130

3- PESTICIDE SAMPLES 

(Includes 702(b) portion)

DO NOT FUMIGATE PESTICIDE SAMPLES

INTRODUCTION

The objectives of FDA's pesticide monitoring program are 

to gather information on levels and incidences of pesticide 

residues in the nation's food supply and to initiate 

enforcement actions against shipments of foods and feeds 

found to contain illegal pesticide residues. To meet both 

objectives, it is necessary to collect samples of foods and 

feeds for pesticide residue analysis. This section

describes procedures for the collection of raw agricultural 

and processed commodity samples. These procedures 

apply to both domestic and import arenas. Additionally, a 

separate set of procedures for collecting samples in 

conjunction with special investigations, such as samples 

collected to determine levels of pesticide residues in soil, 

water, and growing crops, is included.

For pesticide samples, the laboratory will maintain a 

portion of the composited sample as the 702(b) [21

U.S.C.372(b)] portion.

Pesticide sample sizes no longer differentiate between 

Surveillance and Compliance Samples. All pesticide 

samples will be collected as directed below. Remember to 

include the state and county or country of origin in the 

Flag. See IOM 4.4.10.1.8.

For appraisal purposes, you must Flag each Domestic as to 

the basis for sampling in accordance with the definitions 

below.

Pesticide Compliance Sample. Collected on a selective

basis as a result of inspectional or other evidence of 

suspected misuse of a pesticide on a food or feed

commodity or as a follow-up to a "Pesticide Surveillance 

Sample" that was found to contain actionable levels of 

pesticide residues. Flag "Pesticide Compliance".

Pesticide Surveillance Sample. Collected on an objective 

basis where there is no evidence or suspicion of pesticide 

misuse on a food or feed commodity. Flag "Pesticide

Surveillance".

Divisions have the option to collect 1 intactshipping case of 

fresh produce from packing sheds or large produce 

warehouses. The one case must meet the minimum 

sample size specified below. This "one case" option may be

used on any import sample or on domestic Pesticide

Surveillance Samples, if the collector can be assured that 

the "one case" collected is representative of the lot or 

field. If the collector is not assured of this, collect the 

samples according to the instructions below. This "one 

case" sampling does not apply to large items such as 

melons.

NOTE: If "one case" option is used for surveillance samples

of domestic produce, describe in the Remarks Section of

the CR, the basis for determining that the sample is 

representative of the lot or field.

Plant products: description of primary samples and 

minimum size of laboratory samples (total weight of all

subs or units collected).
INVESTIGATIONS OPERATIONS MANUAL 2023 SAMPLE SCHEDULE CHART 3

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Commodity classification Examples

Nature of primary samples

to be taken

Minimum sample size and 

number of units of each 

laboratory sample

1. PRIMARY FOOD COMMODITIES OF PLANT ORIGIN

All fresh fruits, All fresh vegetables, Frozen bulk produce (not retail) except dry pulses

Small sized products

units generally < 25 g

Berries, peas, olives whole units, or packages, or units

taken with sampling device

1 kg (2.2 lbs.)

Medium sized products

units generally 25 - 250 g

Apples, oranges, corn on the cob, 

potatoes

whole units, or units taken with

sampling device

1 kg (2.2 lbs.) (at least

10 units)

Large sized products

units generally > 250 g

Cabbages, lettuce, cucumbers, grapes

(bunches, except for sulfites), sweet 

potatoes

whole units, units taken with

sampling device 

2 kg (4.4 lbs.) (at least 5 

units) 

Pulses, Cereal grains soybeans, peas, lentils, rice, wheat

(except from rail carloads)

1 kg (2.2 lbs.)

1 kg (2.2 lbs.)

Tree nuts (except coconuts) 1 kg (2.2 lbs.)

coconuts 5 units

Oilseeds peanuts 0.5 kg (1.1 lb.)

Seeds for beverages and

sweets

See CP 7304.004 0.5 kg (1.1 lb.)

Herbs

(For dried herbs see section 3 of this 

Table)

fresh parsley

others, fresh 

whole units or units taken

with sampling device 

0.5 kg (1.1 lb.)

0.2 kg (0.5 lb.) 

Spices dried whole units or units taken with 

sampling device

0.1 kg (0.25 lb.)

2. PRIMARY ANIMAL FEED COMMODITIES

Primary feed commodities of plant origin

Legume animal feeds, and other 

forages and fodders

whole units, or units taken with

sampling device

1 kg (2.2 lbs.)

(from at least 10 units)

Straw, hay and other dried

products

whole units, or units taken with

sampling device

1 kg (2.2 lbs.)

(from at least 10 units)

Note. See IOM Sample Schedule Chart 4, Wheat Carload Sampling for guidance in the collection of samples by trier from railcars

and trucks.

3. PROCESSED FOODS OF PLANT ORIGIN

Secondary food commodities of plant origin, dried fruits, vegetables, herbs, milled cereal products

Derived products of plant origin, teas, vegetable oils, juices, by-products for animal feed and miscellaneous products

Manufactured foods (single ingredient) of plant origin,

Manufactured foods (multi-ingredient) of plant origin, including products with ingredients of animal origin where the 

ingredient(s) of plant origin predominate(s), and breads

Products of high unit value packages or units taken with a

sampling device

0.1 kg* (0.25 lb.)

Solid products of low bulk density Hops, Tea packaged units, or units taken

with a sampling device

0.2 kg (0.5 lbs.)

Other solid products bread, flour, apple pomace, dried fruit packages or other whole

units, or units taken with a 

sampling device

0.5 kg (1.1 lbs.)

Liquid products vegetable oils, juices packaged units, or units taken

with a sampling device

0.5 L or 0.5 kg

* A smaller laboratory sample may be taken from a product of exceptionally high value but the reason for doing so should be noted in 

the collection report.

4. EGGS AND DAIRY PRODUCTS

Poultry eggs

Eggs, except quail and similar whole eggs 12 whole chicken eggs,

6 whole goose or duck eggs

Eggs, quail and similar whole eggs 24 whole eggs

Milks whole unit(s), or unit(s) taken with

a sampling device

0.5 L
SAMPLE SCHEDULE CHART 3 INVESTIGATIONS OPERATIONS MANUAL 2023 

4-132

Commodity classification Examples

Nature of primary samples

to be taken

Minimum sample size and 

number of units of each 

laboratory sample

5. PROCESSED FOODS OF ANIMAL ORIGIN

Secondary food commodities of animal origin, skimmed milks, evaporated milks, and milk powders

Derived edible products of animal origin, milk fats, butters, butter oils, creams, cream powders, caseins, etc. 

Manufactured food (single ingredient) of animal origin,

Manufactured food (multi-ingredient) of animal origin, (including products with ingredients of plant origin where the ingredient(s) of 

animal origin predominates(s))

Liquid milk, milk powders, evaporated

milk and cream, cream, dairy ice 

cream, yogurt

packaged unit(s), or unit(s) taken

with a sampling device

0.5 L (liquid) or 0.5 kg(solid)

Notes. (i) Evaporated milks and evaporated cream in bulk must be mixed thoroughly before sampling aseptically.

(ii) Milk powder in bulk should be sampled aseptically, passing a dry borer tube through the powder at an even rate.

(iii) Creams in bulk should be mixed thoroughly with a plunger before sampling but foaming, whipping, and churning must 

be avoided.

Butter and butter oils (butter, whey

butter, low fat spreads containing 

butter fat, anhydrous butter oil, 

anhydrous milk fat)

whole or parts of packaged 

unit(s), or unit(s) taken with a

sampling device 

0.2 kg or 0.2 L

Cheeses, including processed

cheeses

units 0.3 kg or greater whole unit(s) or units taken 

aseptically with a sampling device

0.5 kg

units < 0.3 kg whole unit(s) 0.3 kg

Note. Cheeses with a circular base should be sampled by making two cuts radiating from the center. Cheeses with a rectangular 

base should be sampled by making two cuts parallel to the sides.

Liquid, frozen, or dried egg products unit(s) taken aseptically with a

sampling device

0.5 kg
INVESTIGATIONS OPERATIONS MANUAL 2023 SAMPLE SCHEDULE CHART 3

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9. GRAPES FOR SULFITES

Collect approximately 900 - 1800 g (2 - 4 lbs.) of grapes 

[10/100 - 200 g (1/4 to 1/2 lb.) subs]. Each subsample will 

consist of individual grapes, not bunches, and will be 

collected from different lugs (cases) on as many different 

pallets in the lot as possible. No grapes that are damaged 

during the sampling procedure should be included in the 

sample. However, grapes with damage prior to sampling 

may be included in the sample.

If sulfiting pads are present, grapes sampled should be 

selected from areas closest to and directly under the pad.

Monitoring activities should be focused upon lots of 

grapes with the highest potential for violative sulfite 

residues.

Direct efforts to lots of grapes sulfited through fumigation 

or to lots with multiple fumigations especially towards the 

end of the harvesting season and also to lots with 

significant numbers of damaged grapes (split, crushed, or 

unusually wet, if such damage is apparent). 

Sample lots of grapes sulfited through the use of sulfiting 

pads, with o r without additional fumigation . 

If a t all possible, sample lots subjected to the following

conditions, which could cause high sulfite residues: 

• Lots subjected to un-refrigerated storage of 2 or 

more hours during warm weather. 

• Unusual shipping conditions (ships at sea during 

heavy storms). 

• Lots with significant numbers of damaged grapes. 

• Lots containing evidence of sulfite pad damage 

sufficient to cause spilling of sulfiting agent onto 

grapes. 

Special Sample Handling

Place sample in tightly closed airtight glass mason jar(s) 

or sealed plastic bag(s). Although no effort should be

made to commingle subsamples, more than one 

subsample may be placed in the same container for 

shipping convenience.

Appropriate cooling procedures are:

Place samples in shipping container or cooler with 

sufficient ice or other refrigerant to keep sample 

refrigerated until arrival at the laboratory. Sample should 

be placed immediately in a refrigerator at or below 7 

degrees C. If sample is not to be analyzed within a few 

hours, the sample should be placed in a freezer, which is 

maintained at or below -20 degrees C.

Or, if the sample is frozen, place the sample in a container 

with sufficient dry ice to keep the sample frozen until

arrival at the lab. The sample should then be placed in 

freezer upon arrival at the laboratory.

1. FISH AND SHELLFISH PRODUCTS

NOTE: THIS SAMPLE SIZE FURNISHES SUFFICIENT FISH 

FOR HEAVY METAL ANALYSIS.

Packaged Fish, fresh, frozen, smoked, cured, or shellfish 

(except oysters) 

Collect 12 subs - minimum sub size is 453 g (1 lb.)

Bulk Fish - .453 - 1.35 kg (1 - 3 lb.)/fish 

Collect 12 subs, each sub to consist of 453 g (1 lb.) of 

edible fish

Bulk Shellfish (except oysters) 

Collect 12 - 453 g (1 lb.) subs

Canned Fish and Shellfish Products (except oysters) 

Collect 12 subs - 5 cans per sub

Other Fish and Shellfish Products

Oysters - Collect 12 1-pint subs

Fish Flour and Meal

Follow the guidance in section 5 above.

SWORDFISH FOR HEAVY METALS

These sample sizes must be used whenever sampling 

swordfish, either for audit, surveillance, or compliance 

purposes. 

Whole Fish (dressed, head removed)

Characterize lot in terms of fish sizes, i.e., small, medium, 

and large. The following dressed weight ranges are used 

for classification:

Small Fish - Weighs less than 36.4 kg (80 lbs.) 

Medium Fish - Weighs 36.4 - 54.5 kg (80 - 120 lbs.) 

Large Fish - Weighs more than 54.5 kg (120 lbs.)

For lots consisting of 12 or more fish, the representative 

sample to be collected will be determined by the following 

formula:

ns = (n) (Ns)/N

ns = the number of fish in a given weight range from 

which subsamples must be taken

n = total number of subsamples to be collected from 

the lot. (In using this formula n will always equal 12)
SAMPLE SCHEDULE CHART 3 INVESTIGATIONS OPERATIONS MANUAL 2023 

4-134

Ns = the number of fish in a given weight range in the lot

N = the total number of fish in the

lot

Example: If a lot consists of 25 fish and is characterized 

as: 5 small fish [less than 36.4 kg (80 lbs.)], 15 medium 

fish [36.4 - 54.5 kg (80 - 120 lbs.)], and 5 large fish [greater 

than 54.5 kg (129 lbs.)], the sample should be collected as 

follows: 

small fish (12)(5) = 2.4 = 2

25

medium fish (12)(15) = 7.2 = 7

25

large fish (12)(5) = 2.4 = 2

25

TOTAL SAMPLE: 11 sub samples

Usually, the total sample will consist of 12 subsamples. 

However, due to rounding numbers of subsamples 

determined by the formula may be 11 or 13 in some 

instances. The total sample should consist of the specific 

number of sub samples determined by the formula in 

all cases. 

Each sub sample should consist of approximately a 0.5 kg 

(1 lb.) steak cut from just below the nape of the fish. Care 

should be taken to avoid mutilation of fish. The sub must 

consist of edible flesh. If a private laboratory is 

conducting the analysis, individual fish from which the

sub sample is taken should be identified with a tag or

other suitable method. This will permit FDA to take audit 

samples from the same fish sampled by the private

laboratories. 

For lots consisting of 12 or less fish, collect 1 sub from 

each fish.

Swordfish Loins (slabs or sides cut from dressed whole 

fish which has been boned or trimmed). 

Use the same formula stipulated for whole fish, with the 

exception that the following weight ranges should be used 

to characterize the lot: 

Small fish loins = weighs 9.1 - 18.2 kg (20 - 40 lbs.) 

Medium fish loins) = weighs 18.2 - 36.4 kg (40 - 80 lbs.) 

Large fish loins = weighs over 36.4 kg (80 lbs.) 

Swordfish Steaks 

Collect 12 sub samples, i.e., 12 steaks, at random from 

different containers in the lot (as many as possible)

Canned Swordfish

Collect 12/453 g (1 lb.) sub samples at random

11. RETAIL CONTAINERS CANNED, FROZEN AND DRIED 

FOODS

Collect retail containers equal to the number of primary 

units specified above.

12. SPECIAL INVESTIGATIONS

Growing Crops

Superimpose an imaginary grid on the field dividing it into 

approximately 100 areas. Randomly select 10 areas to form 

a representative sample of the field. Collect one pound subs 

from each area. Combine to form a composite. If a 

sample is being collected to document drift, etc. DO NOT 

composite subs. In addition, diagram the field in the 

Remarks Section of the C/R and indicate sub number where 

each sub was collected.

For leafy vegetables, such as lettuce, cabbage, etc.: INV

Samples collected in the growing field should be 

representative of local commercial harvesting practices If 

the local practice is to strip outer leaves at the time of 

harvest, this practice should be followed when collecting 

field samples. In head lettuce, for example, the lettuce 

may be packed directly into shipping cartons in the field, in 

which case 6 or 8 outer leaves are left on the head to be 

removed at the retail outlet. In other instances, each head 

is stripped of 2 or 3 outer leaves and individually wrapped 

in plastic, placed in shipping cartons, and the consumer 

receives the produce in this condition. Describe sampling

method on C/R and describe how packing shed handles 

produce prior to shipping (e.g., washing, waxing, stripping, 

etc.). 

Soil Samples

Collect soil samples from fields according to the following

3x3 grid diagram: 
INVESTIGATIONS OPERATIONS MANUAL 2023 SAMPLE SCHEDULE CHART 3

4-135

a b c 

1 o o o 

2 o o o 

3 o o o 

Sample at the 9 locations indicated by the "o". If the field 

being sampled is very large, you may have to sample it 

using a 4x4, 5x5, or even larger grid pattern.

Subs are to be placed in clean quart glass jars, which 

have been washed in water, rinsed in methanol, and air 

dried. If methanol is not available, use washed, air dried 

jars and submit an empty jar as a control. Note on CR that 

jars were or were not rinsed with methanol. 

Obtain two "6 in" deep plugs (1-2 in. in diameter from each 

sampling location. Place two plugs from each location in 

cleaned glass jars, place clean aluminum foil over top of 

jar and seal with screw cap. 

Soil samples should be submitted to the lab at 4° C (39° 

F) or below. 

Water Samples - Collect 3 quarts of water from the same 

sampling source (e.g., faucet, stream, lake, etc.) and place 

in cleaned, washed and methanol rinsed jars as described

under "Soil Samples". 

Submit water samples to lab at 4° C (39 ° F) or below.

Growing Crops

Superimpose an imaginary grid on the field dividing it into 

approximately 100 areas. Randomly select 10 areas to 

form a representative sample of the field. Collect one 

pound subs from each area. Combine to form a 

composite. If a sample is being collected to document 

drift, etc. DO NOT composite subs. In addition, diagram 

the field in the Remarks Section of the C/R and indicate 

sub number where each sub was collected.

GENERAL

Official Samples shall be collected whenever feasible 

unless they are not required to accomplish the objective 

of the assignment. Investigational Samples shall be

collected only when Official Samples are not readily 

available. 

Consult with your supervisor in cases of doubt as to 

sample cost, size, or collection technique.

When collecting samples in glass jars, line the lids with 

aluminum foil which has been certified by the 

laboratory as contaminant free or use Teflon lined lids. 

If shipment of shell eggs is required and breakage may 

result during transit, subs may b e broken, shells

discarded, and liquid magma collected in clean glass jars. 

Each sub jar should be properly identified.

Samples collected at Packing Sheds should be 

representative of the produce as shipped in commerce. 

DO NOT strip outer leaves from subs collected at packing 

sheds from bulk lots, shipping cartons ready for shipment, 

in-transit lots or at final destination. If the packing shed 

practice is to strip outer leaves prior to shipment, follow 

this practice when collecting the samples. Describe the 

sampling method on the C/R.

DO NOT USE magic markers, etc. to identify sub bags, 

because the ink may affect assay results. Use stick on 

labels to identify sub bags.

Collect samples in the container in which the dealer is 

packaging the product. If the dealer is packaging the

product in plastic bags, collect sample in these bags. If

the firm is not packing the product, collect the

samples in paper bags, cardboard cartons, etc. Do not

use plastic bags as this may interfere with the analysis, 

unless the bags are certified as contaminant free by your

division laboratory. 

Samples must be delivered as promptly as possible to

the laboratory if regulatory action is to be taken against 

actionable lots. 

Hold samples in cold storage until ready to be shipped 

or delivered to the laboratory. If the sample is of a hard 

fruit or vegetable (such as apples, pears, butternut
SAMPLE SCHEDULE CHART 3 INVESTIGATIONS OPERATIONS MANUAL 2023

4-136

squash), and is shipped overnight delivery, it can be

shipped to the laboratory unrefrigerated, but the FDA

525 should direct refrigeration upon receipt.

Use aseptic technique, where applicable, when

collecting samples of finished products from bulk

containers.
INVESTIGATIONS OPERATIONAL MANUAL 2023 SAMPLE SCHEDULE 4

4-137

4- WHEAT CARLOAD SAMPLING 

I. SAMPLING NORMALCARS

CAUTION: WHEN USING A GRAIN PROBE, BE CAREFUL 

NOT TO CLOSE THE TRIER COMPARTMENT DOORS ON 

YOUR FINGERS.

Collect samples only of specific assignment.

A. Equipment

1. Double tube compartmented trier, 60 in. long 

2. Sampling cloth at least 60 in. long 

3. 1000 ml plastic graduate 

4. Paper bags or other suitable containers capable of 

holding more than one quart of sample and do not use 

canvas bags. 

5. FDA Metal Car Seals for resealing railroad cars 

6. Aluminum ladder 

7. Block and tackle to open railcar door 

B. Drawing Sample

Principal sources of grain samples are railcars, barges, and 

trucks. Draw 5 probes (in duplicate) for each sample taken 

as described below. However, if the sample is to be Field 

Examined, an initial sample of 5 probes drawn as indicated 

below will be sufficient.

Probe samples from railcars and trucks as follows:

Probe #1 - From Center of car

Probe #2 - From 3-5 feet back from door post toward end 

of the car and approximately 2 feet from the side of the 

car.

Probe #3 - From 3-5 feet from the same end of the car, but 

approximately 2 feet from the opposite side of car as 

Probe #2.

Probe #4 - Same as Probe #2, but opposite end of car.

Probe #5 - Same as Probe #3, but opposite end of car.

Sketches I and II below are alternatives showing the 

approximate sampling locations.

 I II

 5 5 

 o o 

 4 4 

 o o 

 1 1 

 o o 

 2 2 

 o o 

3 3 

 o o 

Insert trier in the grain at an angle of about 10° from the 

vertical, with the slot up and closed. Open slots. Give trier 

2 or 3 short up and down motions, so that the openings 

will fill. Close slots (SEE CAUTION AT BEGINNING OF 

SCHEDULE), withdraw trier and carefully empty over 

sampling cloth. The cloth should be long enough to catch 

product from each compartment separately when you 

open the trier compartment doors; e.g., about 6 feet long.

C. Field Examination

Examine each pocket of the probe separately, looking for 

evidence of pink wheat, rodent pellets, insect damage and 

uneven loading or plugging. Note any insect infestation 

and record types of insects and whether live or dead. 

Count and report for each probe the number of rodent 

pellets, or rodent pellet fragments. Follow procedure in 

I.C.2 below. Count as pellets any that are sufficiently large 

to be readily identified by size, shape, surface coating, 

and/or presence of rodent hairs. Report the number of 

rodent pellets per sub. Measure the volume of each sub 

(probe) in quarts and calculate the average number of 

pellets per quart per I.C.2.a below. Place pellets from each 

sub in separate vials and submit with each wheat sub. 

Place each of the wheat subs in clean, paper bags.

Do not use canvas bags or take glass jars into railcars.

Substantially larger loads will require additional probing or 

larger samples taken from falling grain during loading or 

unloading operations.

Submit all suspect samples to laboratory for confirmatory 

analysis.

1. Non-Violative Samples. When field examination shows 

sample as non-violative, return grain to the car, unless 

collected for pesticide analysis. Report results in the 

Remarks Section of the C/R. 

2. Violative Samples

a. Rodent Pellet Contamination. The guideline for 

determining whether wheat is violative due to 

rodent contamination is: "9 mg or more rodent 

excreta pellets and/or fragments of rodent excreta 

pellets per kg of wheat." 

NOTE: Since it is impractical to weigh rodent pellets and 

wheat in the field, the following estimations can be used. 

Mouse pellets average approximately 8.7 mg each and a 

kilogram of wheat about 2.35 pints. This translates roughly 

as 1 pellet per quart of wheat or 1/2 pellet per pint.
SAMPLE SCHEDULE CHART 4 INVESTIGATIONS OPERATIONS MANUAL 2023 

4-138

Where your field examination reveals one or more rodent 

pellets (or you can estimate that sufficient fragments of 

rodent pellets exist to equal one pellet) in a quart of 

wheat, take duplicate probes to furnish the claimants 

portion. Take the duplicate probes from the same 

locations as the original probes. Place the duplicates in 

separate containers and identify these to correspond with 

the original probes.

b. Pink Wheat. Where evidence of pink wheat or other 

fungicide treated wheat is found, collect 15 probe 

samples. Take 5 probes from each end of the car and 

5 probes from the center of the car. Submit the 

three 5-probe portions separately, using new clean 

containers. 

c. Insect Damaged Kernels. The violative status of 

these samples should be established by laboratory 

analysis. When any evidence of insect damage is 

revealed by cursory examination, collect duplicate 

samples and submit for laboratory analysis. 

3. Resealing Cars See IOM 4.3.4. 

4. Procedures for Actionable Cars. If field examination 

reveals an average of one or more rodent pellets per 

quart or gross evidence of insect-damaged kernels, 

evidence of plugging, or "pink wheat" contamination, 

determine any movement of the car or other 

disposition of the grain and notify your supervisor 

immediately. 

5. Preparation of Sample for Laboratory Analysis. If a 

sample can be delivered to the laboratory promptly 

and confirmatory analysis handled expeditiously, 

freezing of the FDA subsamples is not necessary. The 

claimant's (702(b)) portion of the sample, however, 

must be frozen. It is preferable to freeze the 

subsamples in paper bags. If a freezer is not available, 

the subsamples (in paper bags) can be placed in a 

cooler box with dry ice. Do not use glass jars with dry 

ice. Officially seal all subsamples. If dry ice is used, you 

must label the shipping container as described in IOM 

4.5.5.8.6. See Exhibit 4-19. Indicate frozen storage on 

the FDA 525. 

D. Special Reporting

Submit an Analyst Worksheet (FDA-431) for each sample

analyzed and found in compliance. See IOM 4.3.7.1. If field 

examination shows the sample is possibly actionable, 

report analytical results in Remarks Section of the C/R.

II. SAMPLING PLUGGED CAR

If uneven loading, layering, or "plugging" is suspected, 

contact your supervisor as to whether to sample or not. A 

'plugged" car is a railcar, truck, or barge load of grain

where the contamination is suspected of being in only one 

portion or layer of grain. Plugging is usually the deliberate 

mixing of violative grain below the surface or in isolated 

pockets of grain.

A. Equipment

Equipment needed is the same as in 1.A. above except:

1. Double tube grain probe must have individual 

compartments permanently separated. 

2. Small containers of sufficient size to hold the contents 

of each compartment of each grain probe. 

B. Procedure

1. In the Remarks Section of the C/R, draw a diagram 

showing actual "plugging" pattern suspected. 

2. Each sample consists of thirty probes of grain with each 

probe compartment maintained as a separate sub. 

Each sample thus consists of 300-330 subs depending 

on whether a 10 or 11 compartment probe is used and 

if grain depth is sufficient to insert the probe to fully 

cover all compartments of the probe. 

3. Probe each load and number the probes as follows: 

1 4 7 10 13 16 19 22 25 28

2 5 8 11 14 17 20 23 26 29

3 6 9 12 15 18 21 24 27 30

4. Identify the subs by probe number plus compartment 

letter starting with small "a" as the compartment 

nearest the tip of the probe. 

Example:

5. Submit sample to your division's servicing laboratory. 

See IOM 4.5.5.2.
INVESTIGATIONS OPERATIONAL MANUAL 2023 SAMPLE SCHEDULE 5

4-139

5- IMPORTED WHITEFISH SAMPLING 

SCHEDULE 

GENERAL

This Sample Schedule objective is to maintain import lot

integrity from time of importation thru FDA inspection or 

examination and final action.

Shipments will be special manifested from non-lab ports 

to DO cities and other cities designated by the DD as FDA 

inspection points. These shipments will arrive in Customs 

bonded trucks under seal applied by Customs at the port 

of entry. Customs Entry documents and commercial 

invoice will accompany each shipment. The commercial 

invoice contains a description of the lots in the shipment 

and will serve as a guide in the selection of the lots to be 

sampled.

1. Special Manifested Shipments: 

a. Determine if seals are intact and record seal 

number. 

b. FDA metal seals may be broken and lots checked 

against invoice. 

c. Customs seals may be broken only if authorized by 

Customs. 

d. Lots which are not to be examined will be released 

by completing the "MAY PROCEED" block of the 

FDA-701. 

e. Sample lots to be examined by using either the 

Single or Sequential Sampling Plan depending on 

whether examination is made at the DO Lab or at 

the dock. The Sequential Plan can only be used 

where additional fish are immediately available for 

cutting. 

2. Definition of a Lot & Selection for Examination. 

a. A lot is defined as "Each group of fish of a distinct 

size, listed in the invoice as from a distinct lake, will 

be considered as a separate lot. Where an invoice 

does not list lakes of origin of boxes of fish in a 

shipment, fish of the same size and kind will be 

considered to comprise a single lot. When the size 

of the fish or lakes of origin in a shipment are not 

specified, the shipment will be treated as a single 

lot." 

b. Limit sampling to lots containing 5 or more boxes 

unless deliberate splitting up of lots is suspected. 

c. Basis for Sampling. Select lotsfor sampling on either 

a "selective" or "objective" (random) basis. The 

criteria in selective sampling may be prior 

knowledge or suspicion that fish listed as from a 

given lake are likely to have excess cysts; that the 

shipper has been known to manipulate shipments; 

etc. Regardless of the reason for selective sampling, 

record the basis for sampling each lot in your 

examination report. Simply list the basis as 

"selective" or "objective" next to the results of each 

lot sampled. 

d. Normally, select boxes in a lot for sampling at 

random. However, where there's evidence of 

layering, selectively sample the suspect boxes. 

3. Sampling Schedule. 

a. Imported samples of whitefish & related fish for 

parasites. The sampling schedules estimate lot

quality more precisely, thereby reducing the 

likelihood of passing a lot which should be detained, 

or vice versa, due to an inadequate sample. 

SCHEDULE A below is a single sample plan for use in 

collecting samples for examination in the division 

lab or other location where it is impossible or 

undesirable to return and obtain additional fish.

SCHEDULE B below contains sequential sampling

plans for use when the exam is made at a customs 

office or a carrier's dock where you have immediate 

access to the lot and can obtain additional fish, if 

necessary.

The sequential plan for lots of 20 to 100 boxes is 

presented in tabular form. The sequential sample

plan for lots of 100 or more boxes is presented in a 

sampling chart. For small lots of 5-20 boxes, a 

sequential sample plan is not feasible. All import

sampling plans are based on lot size and the sizes of 

the fish in the lot. When lots are very good or very 

poor quality, in terms of cyst infestation, double 

sample plans require a smaller sample size on the 

average than single sampling plans, to reach a 

decision.

b. Domestic Samples for Parasites.

i. For Laboratory Examination. Lots of 11 or more 

boxes; Collect at least 25 fish from a 

representative number of boxes. For small lots, 

under 11 boxes; Collect 12 fish from a 

representative number of boxes. 

ii. For Examination in Other Than Laboratory. Cut a 

preliminary sample in accordance with the 

appropriate double sampling plan, Schedule B. 

Cut the additional sample where indicated or 

bring the additional sample to the laboratory for 

examination.
SAMPLE SCHEDULE CHART 5 INVESTIGATIONS OPERATIONS MANUAL 2023 

4-140

SCHEDULE A - SINGLE SAMPLE PLAN

Number of Boxes 

in Lots

NUMBER OF KG'S (POUNDS) IN A SAMPLE 1/

Jumbo or Large 2/ Medium 2/ Small 2/

5 - 19 boxes

20 - 100 boxes

100 or over

12.7 kg (28lbs)

24 kg (73lbs)

32 kg (70lbs)

10.5 kg (23lbs)

20.5 kg (45lbs)

25.5 kg (56lbs)

7.3 kg (16lbs)

15 kg (33lbs)

17.8 kg (39lbs)

1/ When an invoice does not designate the size of the fish 

in the shipment and inspection reveals more than one 

size in the lot, use sampling plan for medium fish.

2/ RANGE OF WEIGHT OF FISH IN EACH SIZE CLASS:

SMALL Under 675 g (1 1/2lbs)

MEDIUM 675 g (1 1/2lbs) & under 1.4 kg (3lbs)

LARGE 1.4 kg (3lbs) & under 1.8 kg (4lbs)

JUMBO Over 1.8 kg (4lbs)

SCHEDULE B - SEQUENTIAL SAMPLE PLAN

1. Limited to lots of 20 - 100 boxes. 454 kg (1000lbs) to 2272 kg (5000lbs)

Size of Fish 1/ Size of preliminary Sample Cysts/45.5 Kg (100lbs) in Preliminary Sample Size of ADD'L SMPL Cysts/45.5 Kg (100lbs) in sample

PASS DETAIN TAKE ADD'L SMPL PASS DETAIN

Large & Jumbo

Medium

Small

16 kg (35lbs)

12.3 kg (27lbs)

8.2 kg (18lbs)

30 or less

26 or less

38 or less

70 or more

67 or more

61 or more

31-69

27-66

39-61

28.6kg (63lbs)

19.5 kg (43lbs)

11.8kg (26lbs)

49 or less

49 or less

49 or less

50 or more

50 or more

50 or more

1/ When an invoice does not designate the size of the fish in the shipment and inspection reveals more than one size in the lot, use sampling plan for medium fish.

2/ For lots of 100 boxes or over, use the Sequential Sampling Chart for the particular size fish in the lot.
INVESTIGATIONS OPERATIONS MANUAL 2023 SAMPLE SCHEDULE CHART 5

4-141
SAMPLE SCHEDULE CHART 6 INVESTIGATIONS OPERATIONS MANUAL 2023

4-142

6- MYCOTOXIN SAMPLE SIZES 

1 If you have any questions, please consult the appropriate FDA Center for further assistance. 2 Sample unit integrity must be maintained. 3 For sampling of consumer packages, please consult the IOM or the appropriate FDA Center for further assistance. 4 If a lot is more than 150,000 lbs., please consult the appropriate FDA Center for further assistance. 5 If a lot is more than 2,000 bags, please consult the appropriate FDA Center for further assistance. 6 When foods are not designated as animal food, the food should be sampled according to the schedule for human food.

MYCOTOXIN SAMPLE SIZES

Please consult 21U.S.C. 372(b) regarding duplicate portion for 702(b)

HUMAN FOOD PRODUCTS

Product PACKAGE TYPE/

LOT SIZE: lbs. 6

NUMBER OF INCREMENTS 

(SAMPLE UNITS) TO 

COLLECT 7

MINIMUM SAMPLE 

UNIT SIZE: g (lb.)

MINIMUM TOTAL SAMPLE 

SIZE: kg (lbs.)

Fluid:

e.g., milk and apple juice

≤ 22,000 6 500 mL (16 fluid oz.) 3 L (96 fluid oz.)

> 22,000 ≤ 150,0003 20 250 mL (8 fluid oz.) 5 L (160 fluid oz.)

Processed snack food: 

e.g., corn chips, candy bars with/without nuts

Milk Products: 

e.g., cheese, yogurt 

Consumer 8 or Bulk 10 454 (1.00) 4.5 (10)

Ground Products and Finished Food

Grain products 

 e.g., meal, flour grits, pasta, and breakfast 

cereals 

Edible seeds, oil seeds and nut products 

 e.g., smooth butter, flour, paste

Spices; dried ground

 e.g., ginger, pepper 

≤ 2,200 10 454 (1.00) 4.5 (10)

> 2,200 ≤ 4,400 12 454 (1.00) 5.5 (12)

> 4,400 ≤ 22,000 15 454 (1.00) 6.8 (15)

> 22,000 ≤ 150,000 9 20 454 (1.00) 9.1 (20)

Whole and non-Ground Products

Whole Grains

 e.g., shelled corn, wheat, sorghum, barley, rice 

Edible and oil seeds:

e.g., melon, pumpkin, sesame, soybean, sunflower

Spices; dried whole: 

 e.g., ginger, nutmeg 

Beans:

 e.g., coffee beans, pinto beans

≤ 220 10 454 (1.00) 4.5 (10)

> 220 ≤ 2,200 15 303 (0.67) 4.5 (10)

> 2,200 ≤ 4,400 20 227 (0.50) 4.5 (10)

> 4,400 ≤ 22,000 30 227 (0.50) 6.8 (15) 

> 22,000 ≤ 150,0003 50 182 (0.40) 9.1 (20)

Peanuts and tree nuts (shelled or in-shell), 

except in-shell Brazil nuts

 e.g., peanuts, almonds, pecan, pistachios

Crunchy nut butter 

Dried fruits 

 e.g., figs, raisins

≤ 220 10 454 (1.00) 4.5 (10)

> 220 ≤ 2,200 20 454 (1.00) 9.1 (20)

> 2,200 ≤ 4,400 30 454 (1.00) 13.6 (30)

> 4,400 ≤ 22,000 60 378 (0.83) 22.7 (50)

> 22,000 ≤ 150,0003 100 227 (0.50) 22.7 (50)

Number of bags NUMBER OF SAMPLE UNITS 

TO COLLECT2

MINIMUM SAMPLE 

UNIT SIZE: g (lb.)

MINIMUM TOTAL SAMPLE 

SIZE: kg (lbs.)

Brazil nuts in-shell < 200 20 454 (1.00) 9.1 (20)

> 200 ≤ 800 40 454 (1.00) 18.2 (40)

> 800 ≤ 2,000 10 60 454 (1.00) 27.3 (60)

ANIMAL FOOD PRODUCTS 11

Product PACKAGETYPE/ LOT SIZE: 

lbs.1

NUMBER OF SAMPLE UNITS 

TO COLLECT2

MINIMUM SAMPLE 

UNIT SIZE: g (lb.)

MINIMUM TOTAL SAMPLE 

SIZE: kg (lbs.)

Whole Grains: 

e.g., shelled corn, wheat, sorghum, barley, rice

Oilseeds: 

e.g., soybean, cottonseed

Grain products:

e.g., cracked corn, corn screenings, wheat middling

≤ 4,400 20 227 (0.50) 4.5 (10)

> 4,400 ≤ 22,000 30 227 (0.50) 6.8 (15)

> 22,000 ≤ 150,0003 50 182 (0.40) 9.1 (20)

Oilseed and nut meals

 e.g., peanut meal, cottonseed meal, soybean meal 

Milled corn products

 e.g., corn gluten meal, cornmeal, hominy

Consumer3 or Bulk 40 227 (0.50) 9.1 (20)

Complete mixed animal food

e.g., poultry feed, cattle feed, swine feed, pet food

Consumer or Bulk 20 227 (0.50) 4.5 (10)
INVESTIGATIONS OPERATIONS MANUAL 2023 SAMPLE SCHEDULE CHART 7

143

7- SAMPLING SCHEDULE FOR CANNED 

FRUIT - FILL OF CONTAINER - 

AUTHENTIC PACK 

Collect samples only on a specific assignment or during 

inspections when it appears that the firm is not filling the 

containers to capacity.

1. INVESTIGATIONAL SAMPLES: Authentic Pack 

Preparation. Procedure for preparing authentic factory

packs. 

a. Remove 72 cans, 3 at a time, from packing line after 

fruit has been added and before syruping. 

b. Mark 24 cans with the sub numbers A-1, A-2, A-3, 

etc.; 24 cans with sub numbers B-1, B-2, B-3; and 24 

cans with sub numbers C-1, C-2, C-3, etc. See IOM 

4.5.2.3. 

c. Drain water from the "B" subs by inverting each can 

for 10 seconds, holding the fruit so it doesn't fall out. 

d. Obtain gross weight of each can and record data for 

each series of sub on 3 separate FDA-485 - Field 

Weight Sheets. 

e. Add additional fruit of the same kind and style to the 

"C" subs until the cans are filled to capacity. Do not 

tamp the contents or crush the fruit. 

f. Record the number of fruit pieces added where the 

size of the fruit makes the procedure reasonable. Do 

not make time consuming counts of small pieces of 

fruit or berries. 

g. Obtain the gross weight of the "C" subs after 

additional fruit is added and record on "C" series 

Field Weight Sheet. 

h. Return all 72 cans to the filling line for syruping, 

exhausting, sealing, etc. in normal cannery 

operation. 

i. Remove cans after cooking and cooling. 

j. Identify cans with a single INV Sample number. 

k. Attach FDA-485 - Field Weight Sheets to C/R. 

2. OFFICIAL SAMPLES 

See Sample Schedule Chart 2 for sample size.

3. SPECIAL REPORTING AND PRECAUTIONS 

a. Report coding of cans and shipping cases. 

b. Obtain label specimen(s) for the slack filled 

products. 

c. Report shipments made before the inspection or 

since previous inspection in the same canning 

season. 

d. Do not prepare Authentic Factory Samples when the 

cannery is packing for USDA fill-of-container 

certification unless: 

i. USDA inspection is not continuous. 

ii. USDA Certification is for quality only. 

iii. USDA recommendations for weights are not 

being followed. 

4. SAMPLE SUBMISSION 

Submit samples to your division's designated 

workplan servicing laboratory

 
SAMPLE SCHEDULE CHART 8 INVESTIGATIONS OPERATIONS MANUAL 2023 

144

8- SAMPLING SCHEDULE FOR IMPORTS - 

COFFEE, DATES AND DATE MATERIAL 

1. Coffee - Import Field Examination - Note: Examine a 

minimum of six bags of coffee beans regardless of lot size. If 

a significant number of defective beans or significant 

contamination is found during the examination of these six 

bags, continue the examination using the following schedule, 

which applies for both Import Field Examination and samples 

for laboratory analysis: 

LOT SIZE NO. BAGS TO BE SAMPLED

100 or less 6 bags

101 - 200 10 bags

201 - 1000 15 bags

over 1000 20 bags

a. Sample each bag with a trier, collecting 1/2 pt. of beans 

from the top and 1/2 pt. from the bottom of the bag. The 

total quantity of beans taken from each bag must be the 

same, since both wharf and laboratory examinations are 

to be performed on a composite sample of all beans 

collected. Shake each sub on a #8 sieve nested in a pan. 

Dump the sifted beans from each sub into a bag of 

sufficient size to hold and permit mixing all of the subs 

collected from the lot. Composite the subs. Do not 

maintain individually.

b. Macroscopic Filth Examine the siftings for macroscopic 

filth (live and dead whole insects, excreta pellets, 

extraneous material, and sweepings), reporting findings 

for each sub separately. See IOM 4.3.7.4. Transfer 

macroscopic filth, including all sifted material to a second 

bag and submit to the laboratory for confirmation. If live 

insect infestation is encountered, freeze the filth portion 

containing the insects and the composite coffee bean 

sample. The lot will be detained if a live insect infestation 

is encountered, however, proceed with the defect bean 

examination since the reconditioning process will depend 

on the results. 

c. Defect Bean Examination Thoroughly mix the composite 

sample of coffee beans and remove three-hundred beans 

at random. Examine each individual bean visually (or at a 

5X magnification) for insect tunneling and mold damage. 

Count as moldy only those beans with 1/4 or more of the 

surface being moldy. Note: Each division office has 

examples of the various types of reject beans. 

Accept the lot if twenty or less rejects are found and 

discard the sample. Report your wharf examination into 

FACTS or OASIS, depending on your assignment; no 

Sample Collection Report is necessary. 

d. If twenty-one or more rejects are detected, return beans 

examined to the composite and submit to the laboratory. 

You may discontinue the examination when twenty-one 

rejects are detected. When a sample is submitted to the 

laboratory, all import field examination time is reported

as a field exam in FACTS and the sample collection time 

is reported as an import sample collection. All necessary 

documents for an import sample collection must be 

completed. 

2. Dates & Date Material - Filth

In the laboratory, dates, like in-shell nuts are sampled in 

accordance with a sequential sampling program, i.e., all 

subsamples are composited, and 100 dates are sampled at a 

time, repetitively, until such time they either exceed or fall 

under certain reject numbers. It is not uncommon to have to 

examine 3 to 6 (100 date) repetitions. It is therefore 

important for each subsample to contain at least 200-300 

dates or 2 lbs. of date material. Sample according to the 

following schedule:

NUMBER OF SUBSAMPLES REQUIRED

NO. CONTAINERS IN LOT*

WHOLE 

DATES

DATE 

MATERIAL

100 or less 3 4

101 - 600 8 6

601 - 1200 14 8

1201 - 2000 26 10

2001 - 2800 36 12

2801 - 6000 44 14

6001 - 9600 56 16

9601 - 15000 68 18

Over 15000 82 22

* Schedule is based upon unit containers weighing between 

twenty and one-hundred pounds. For containers exceeding 

one-hundred pounds each, consider as two or more 

containers. For example, a one-hundred and fifty-pound 

container is considered as two containers; a three-hundred 

pound container as three containers, etc. 

a. Identify each subsample separately. 

b. Each lot will be a separate sample. Reconditioning, if 

possible, will be based on lot numbers. 

c. Jujube sampling – collect according to the above 

schedule for dates and date material. Do not identify 

jujube samples as dates, Phoenix dactyllifera. Jujubes, 

Zizphus jujube, are usually labeled as Chinese Red Dates, 

Dried Red Dates, or Honey Dates and are not misbranded

when labeled as such due to long standing use of these 

names. 

d. If live insects are noted, include these as part of the 

sample collected and report on the C.R. which subs 

contained the insects and how many insects, adult, or 

larvae, were noted. If live infestation is noted, place all 

subs from the lot sampled in large plastic whirl-pak bags 

and freeze or place in a cooler on dry ice. 
INVESTIGATIONS OPERATIONS MANUAL 2023 SAMPLE SCHEDULE CHART 9

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9- SAMPLING SCHEDULE FOR COLOR 

CONTAINING PRODUCTS & COLOR 

ADDITIVES 

The following schedule provides general guidance for 

collecting samples of foods and cosmetics to determine 

whether non-permitted colors are present, rather than to 

determine the actual level of a particular color. This 

schedule was developed with the assumption that color 

distribution in the lot will be homogeneous. In the case of 

heterogeneous products, your supervisor should contact 

Center for Food Safety and Applied Nutrition, Office of 

Field Programs, Division of Enforcement (HFS-605) to 

determine sample size. 

INDUSTRY 

CODE

SAMPLE SIZE 

(DO NOT COMMINGLE CODES) (Min. 225 g (8 

oz)/pkg Unless otherwise specified)

GRAIN AND BAKING

02

Whole grains, 

Milled

Grain Products 

and Starch

2 retail packages

03

Bakery Products, 

Doughs,

Bakery Mixes, 

and Icings

2 retail packages

04 Macaroni and

Noodle Products 2 retail packages

05

Cereal 

Preparations

Breakfast Foods

2 retail packages

07

Snack Food Items 

(Flour,

Meal, or 

Vegetable Base)

2 retail packages

DAIRY

09 Milk, Butter, and

Dried Milk Pdts

Liquid Pdts: 2 pts where 

possible

Solid: 2 packages

12 Cheese and

Cheese Products 2 retail packages

13 Ice Cream and

Related Products

6 items per sample (If item is 

single serving; i.e., cup, 

popsicle, bar, etc.) 2 pt.

containers where possible, or 

1 quart or 1/2 gal

14

Filled Milk and

Imitation Milk 

Products

2 pints

EGGS

15 Egg and Egg Pdts

2 dozen whole eggs (e.g. 

colored hard-boiled Easter 

eggs)

2 retail pkg of egg pdts

FISH

16 Fishery/Seafood 

Pdts

2 retail packages.

Any collection of smoked 

salmon should be selective,

based on inspectional 

evidence

MEAT & SIMULATED MEAT PRODUCTS

17

Meat, Meat 

Products

and Poultry

2 retail packages

18 Vegetable 

Protein Pdts 2 retail packages

FRUIT, NUT AND VEGETABLE PRODUCTS

20-22 Fruit & Fruit Pdts

2 retail packages canned or 

glazed.

12 fresh fruit (e.g., oranges, 

etc.).

23 Nuts & Edible 

Seeds 2 retail packages

24-25

Vegetable &

Vegetable 

Products

2 retail packages

26 Vegetable Oils &

Olive Oil

Liquids - 2 pints

Solids - 2 retail packages

DRESSINGS AND SPICES

27 Dressings

& Condiments 2 retail packages

28 Spices, Flavors,

& Salts

Extracts - 2 pints

Solids - 2 retail packages

BEVERAGES

29 Soft Drinks & 

Waters

6 Retail Units (Cans, Bottles, 

Packets)

30

Beverage Bases,

Concentrates, 

and

Nectars

Liquids - 1 pint

Solids (Powder mix, packets) - 

6 Consumer Pkg

Solids - 2/225 g (8 oz) or larger 

containers

31 Coffee and Tea 2 retail packages

32 Alcoholic 

Beverages 2 pints or 1 quart

CONFECTIONS AND DESSERTS
SAMPLE SCHEDULE CHART 9 INVESTIGATIONS OPERATIONS MANUAL 2023 

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33

Candy w/o 

chocolate,

Candy 

Specialties,

and Chewing 

Gum

2 retail packages

34 Chocolate

& Cocoa Pdts 2 retail packages

35

Gelatin, Rennet,

Pudding Mixes,

& Pie Fillings

6 pkgs - smallest consumer 

size

36 Food Sweeteners

(Nutritive) 2 pints

MULTIPLE FOODS, SOUPS, SALADS, BABY FOOD AND DIETARY

37

Multiple Food 

Dinners

Gravies, Sauces 

and

Specialties 

Single Serving Dinners, etc. - 4 

pkgs

Two Consumer Pkgs when 1 

pkg serves more than 2

38 Soups Same as 37 Above

39 Prepared Salad

Products Same as 37 Above

40 Baby (Infant and

Junior) Food Pdts

Sufficient retail pkgs to total at 

least 454 g (1 lb.) of food

41

Dietary 

Conventional

Foods and Meal

Replacements

Same as 37 Above

COLORS AND COSMETICS

50

Color Additives

for Foods Drugs,

and Cosmetics

1. Straight Color 28 

g (1 oz) powder.

2. Color Mixtures 

110 g (4 oz) 

Liquid, paste or 

powder. 

If mixture contains over 50% 

pure dye, 55 g (2 oz) is 

sufficient

53 Cosmetics

Four retail packages of 

the same lot code for 

each shade (color) in the 

product line, if the 

product is strongly 

colored. (e.g., Lipsticks, 

hair coloring products, 

eye mascara, eye liners, 

make up pencils of all 

types) 

Sufficient number of retail 

packages to equal 1 lb. or 1 

pt. of sample if the product

is lightly colored. (e.g., 

creams, lotions, shampoos, 

bath products, shaving 

preparations, and 

perfumes.)

Note: Always collect a 

minimum of two retail units 

of each product.

MISCELLANEOUS

Bulk Items (Any 

bulk food or 

cosmetic)

Dry - 454 g (1 lb)

Liquid - Min 36 fl oz
INVESTIGATIONS OPERATIONS MANUAL 2023 SAMPLE SCHEDULE CHART 10

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10- DRUG SAMPLING SCHEDULES 

(Does not include Antibiotic Preparations)

STERILITY TESTING VITAMINS, DEVICES, & DRUGS 

Type of Product Sample Size1

INV Sample2 Official [702(b) & Check]3

DRUGS 36 86

DEVICES 46 106

LEGEND:

1

Double sample size requirements when individual containers are 2 ml (2 g) or smaller. 

2

INV sample includes units (30 for Drugs & 40 for devices) for examination and 6 units for bacteriostasis. 

3

Official Sample includes units (30 for drugs & 40 for devices) for examination, units (30-40) for check, 20 units for 

702(b) [21 U.S.C. 372(b)] and 6 for bacteriostasis. 

Note: If a lot is aseptically filled into 200 finished units or less, sample no less than 10% of lot.

DISSOLUTION TEST - USP & NF

Unless directed otherwise by your assignment or supervisor, submit samples to your normal servicing laboratory.

SAMPLE SIZE

Collect a 200 tablet portion for drug potency analysis by the collecting division lab, plus a separate 100 tab portion to 

be split for dissolution testing.

MICROBIOLOGICAL EXAMINATION OF DRUGS (Other than for Sterility)

PRODUCT MINIMUM SAMPLE SIZE (Includes 702(b) portion)

Sub Size Nos. of Subsamples

Dosage Form Drugs (See #1 below), Bulk 

Drugs, or Raw Materials for Manufacturing

90 g or 90 ml 10

SAMPLING INSTRUCTIONS

1. Contact the laboratory (which has microbiological testing capabilities) serving your division for sample size

requirements before sampling dosage form drugs containing less than 3 grains, 200 mg, or 25% of the suspect 

ingredient. 

2. Use aseptic technique when collecting samples from raw materials or bulk containers. Implements and sample

containers used must be sterile. Submit controls. See IOM 4.3.6 through 4.3.6.5. 

3. Submit samples to the laboratory with microbiological testing capabilities which serves your division unless directed 

otherwise. 

 
SAMPLE SCHEDULE CHART 11 INVESTIGATIONS OPERATIONS MANUAL 2023

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11- VETERINARY PRODUCTS, FEEDS, & BY- PRODUCTS FOR ANIMAL FEEDS 

1. GENERAL

This sampling schedule may be used as a guide in the collection of surveillance or compliance samples resulting from division 

assignments or as a follow-up to violative inspections and/or investigations. Before collecting follow-up samples to violative 

inspections or investigations, contact your supervisor since it may be necessary for your division to consult with the Atlanta 

Center for Nutrient Analysis (HFR-SE680) when unscheduled compliance sampling is contemplated. 

2. SAMPLE PRODUCT, SIZE, & SPECIAL INSTRUCTIONS

Vitamin-mineral testing, sampling instructions and information. Sample size includes 702(b) portion.

Unless excessive cost is a factor, collect at least 3 intact containers from each lot or control number. When sampling from bulk 

lots, collect appropriate subs from a minimum of 3 different bulk containers in the lot.

DOSAGE FORM VITAMIN-MINERAL PREPARATIONS (Single/Multiple Ingredients)

PRODUCT NO. SUBSAMPLES MINIMUM TOTAL 

SAMPLE SIZE

REMARKS

Injectables 3 vials/amps 30 ml Split samples for sterility 

testing (60 vials/amps)

Tabs/Caps 3 retail units 300 Tabs/Caps Split sample for micro tests 

(10/50 tab/cap subs)

Liquids 3 retail units 4 fl. oz. Split sample for micro tests 

(10/2 fl. oz. subs)

Powders 3 retail units 112 g (4 oz) Same as above

FEEDS & BY-PRODUCTS FOR ANIMAL FEEDS (Vitamin-Mineral Claims)

Vitamin A & D Concentrates,

Supplements & (A&D feeding

3 retail units (1/2 

gal or less)

3 lbs. (1.4 kg) 3 

pints

Limit samples to those products 

containing at least 800 units/g Vit A 

and/or 80 Feeds units/g Vit D

Vitamin B2 (Riboflavin)

Concentrates, Supplements,

& feeds

Same Same Limit samples to those products 

containing at least 20 mg/lb.

Vitamin B12 (Cyanocobalamin)

Concentrates, Supplements & 

feeds

Same Same Limit samples to those products 

containing at least 1 mg/lb

Multiple Vitamins Concentrates, 

Supplements, & feeds.

Same Same Limit samples to those products 

meeting vitamin levels listed above.

3. SAMPLE SUBMISSION

Submit all samples for Vitamin Potency analysis to the Atlanta Center for Nutrient Analysis (HFR-SE680).

Submit samples for filth analysis, microbiological examination, sterility, etc. to your division servicing laboratory. 
INVESTIGATIONS OPERATIONS MANUAL 2023 SAMPLE SCHEDULE CHART 12 

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12- MEDICATED ANIMAL FEEDS SAMPLING Medicated Premixes

1. Investigational Samples (INV Samples)

To demonstrate suspected drug carryover or other chemical contamination during manufacturing, collect 1-900 g (2 lbs.) of static 

residual material in the equipment, and the finished product premixes. 

2. Official Physical Samples 702(b) [21U.S.C.372(b)] Portion Included

For expensive premixes or components, collect a total of 3/170 gm (6 oz) subs; One sub from each of 3 containers. In the case of 

premixes packaged in plastic; e.g., mini-packs, follow instructions under bagged premixes. 

a. Bagged Premixes

Collect 10 - 454 g (1 lb.) subs from each lot. Sample all bags in lots under 10 bags, for a total of 10 subs from the lot.

Collect 454 g (1 lb.) subs from at least 10 different bags selected at random in lots of more than 10 bags. 

b. Bulk Premixes

Collect at least 10 - 454 g (l lb.) subs, from different locations in the lot providing a minimum total sample of 4.5 Kg (10 lbs.). 

3. Documentary Samples (DOC Sample) - Refer to IOM 4.1.4.2 for guidance on the collection of DOC Samples. 

Medicated Feeds

1. Investigational Samples (INV Sample)

Collect 1 - 900 g (2 lb.) of static residual material in the equipment and correlate with finished feed samples to show that residues 

are being carried over into the finished product. 

2. Official Samples (Includes 702(b) portion) 

a. Bagged Complete Feed

Collect a total sample of not less than 2.3 kg (5 lbs.) from each lot. Collect 454 g (1 lb.) subs sampling all available bags from 

lots of 10 bags or less. If lot size is greater than 10 bags, collect 454 g (1 lb.) from each of 10 bags selected at random. 

b. Bulk Complete Feed

Collect at least 10 - 454 g (1 lb.) subs from different points in the bulk lot to obtain a minimum total sample of 4.5 kg (10 lbs.). 

c. Concentrates/Supplements

If the concentrate or supplement is relatively inexpensive, follow the sampling procedures for complete feeds. Limit sampling 

of more expensive drug materials, concentrates, or supplements to no more than 3 containers taking a 170 g (6 oz) or 6 fl. 

oz. sub from each of the 3 containers. 

3. Documentary Samples (DOC Sample) 

a. Feed Subject to MFA Approval - Collect DOC Samples of products processed without required MFA approval. Where the plant 

does not ship in IS commerce, but ingredients are received from IS sources, document the IS nature of drug ingredients and 

the "Held For Sale" status of the finished feed. Labeling of drug ingredients must be submitted. 

b. Misbranded Products - Collect a DOC Sample for misbranding or labeling deficiencies. The failure to provide warning and/or 

withdrawal statements which could present danger to animals or man, or gross evidence of false and misleading therapeutic 

claims, are factors for consideration. 

Sampling Precautions (See IOM Sample Schedule Chart 4)

1. Insert the trier the full length of the bag when sampling bagged premixes, or complete feeds. 

2. Clean trier between sampling the different lots of premixes or complete feeds. 

3. Place subs in a clean, airtight container, preferably clean glass jars. 

4. Do not fumigate samples intended for potency analysis, drug carryover or cross-contamination. 

Sample Submission

Submit samples to your division's servicing laboratory or as directed by your assignment or supervisor. See IOM 4.5.5.2.
EXHBIT 4-22 INVESTIGATIONS OPERATIONS MANUAL 2023

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13- SAMPLE SIZES WITH APPLICATION TO FOOD PRODUCTS FOR ALLERGENS 

(Listed below is the sample size needed for lab analysis. Collect all samples in duplicate, with the duplicate serving 

as the 702 (b) reserve sample)

Product Package 

type

Number of 

sample units Unit size Total sample

Non-liquefied foods, i.e., cereals, cookies Consumer 20 1 lb. 20 lbs.

Pre-liquefied foods, i.e., ice cream, chocolates Consumer 10 1 lb. 10 lbs.

Paste or slurry type Consumer 24

12

8 oz

1 lb.

12 lbs.

12 lbs.

Fluid, i.e., beverages Consumer 10 16 fl. oz 160 fl. oz

IMPORTANT! WHEN TO SAMPLE: At the time of submission of this table to the IOM, only “for cause” allergen samples 

for peanut contamination should be collected. Test methods for additional allergens are under development and the 

field will be notified when they are available for regulatory purposes. The allergen compliance program, when issued, 

will provide additional sampling guidance. “For cause” sampling should be limited to instances where there is a 

reasonable probability that a product may contain an allergen and the labeling of the suspect product does not 

indicate the presence of the allergen. This probability may result from a consumer complaint, a downstream consignee 

laboratory analysis, or other evidence of the presence of the allergen. Also reference IOM Chapter 8, 8.2.3.2.4, 

Allergen Samples, which indicates that allergen samples are to be collected after consultation with OCM/OEIO and 

CFSAN.

a See Laboratory Information Bulletin (LIB) # 4341, Application of Validated, Multiple Laboratory Performance Test 

MethodsSM for the Detection of Peanuts in Food, Vol 21(2) 2005 for details regarding the analysis and quantitation of 

analytical samples.

Note: To be collected from random sites. May combine subs or maintain sub integrity depending on purpose of sampling

Note: Prepare composite following proper grinding and mixing procedures. Separate four 1-lb portions from composite. 

Adapted from U.S. Food and Drug Administration, Office of Regulatory Affairs, Investigations Operations Manual, 

Chapter 4, Sample Schedule 6, Mycotoxin Sample Sizes 
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 4-22 

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4-22 Sample Criteria for Selective Sampling for Filth 

The Agency has defined minimum direct reference seizure criteria to assist in assessing filth of individual 

lots. Criteria for rodent, insect, and bird filth are defined Compliance Policy Guide (CPG) 580.100, Food 

Storage and Warehousing - Adulteration - Filth (Domestic and Import) for human foods, and reiterated in IOM 

sections 4.3.7.2 - 4.3.7.4. When collecting selective samples of products to show adulteration by filth, be guided 

by this criteria.

How FDA products are manufactured, stored or shipped can lead to these products being adulterated

directly. These products can also be deemed to be adulterated indirectly if they were manufactured, stored or 

shipped under insanitary conditions. The evidence of these adverse conditions is obtained through sampling and 

documenting through an inspection (Chapter 5). The criteria for documenting food adulteration in this section 

should serve as guidance for documenting adulteration with other FDA regulated products. It is ultimately the 

investigator’s responsibility to develop the evidence of adulteration and defining the scope of the adulteration 

(lot specific, product specific, location specific). Photographs taken during sampling (Chapter 5) can be very 

useful in court proceedings and litigation. Considerations of how product is packaged or contained should be 

factored when determining how to sample for adulteration. For example, it is harder to show environmental

adulteration of products contained in a metal container or closed system verses a cardboard container where 

there may be no linings to protect the product. 

When evidence of rodent, insect, bird, or other animal activity is encountered during an inspection it is your 

responsibility to assess the evidence you observe and determine and document whether the activity is:

• Current or old

• Isolated or widespread

If it is isolated to one lot (possible FD&C 402(a)(3) charges - contain in whole or in part filth or is otherwise unfit 

for food or 501(a)(1) if a drug or device product).

Widespread adulteration requires evidence and documentation to illustrate all of the firm's susceptible products 

are potentially adulterated because they are being prepared, packed, or held under conditions whereby they 

may be contaminated. These would be possible FD&C 402(a)(4) charges for food or 502(a)(2)(A) charges if a drug 

or device.

Your assessment and documentation of the evidence observed (diagrams, photos and sample collections) will 

determine what actions may be required by either the establishment, the Agency, the Court, or all three to 

correct the problem. The evidence and documentation you collect and develop will be used to show, by a 

preponderance of evidence, that conditions at the firm have resulted, or could result in adulteration.

Your sample collection should be sufficient to document the extent of the violative conditions and not be limited 

to this minimum. Even where these minimum prerequisites are not met, you should collect samples as exhibits

and evidence, particularly where adulteration under section 402(a)(4) of the FD&C Act [21 U.S.C. 342 (a)(4)] or 

501(a)(2)(A) of the FD&C Act [21 U.S.C. 351(a)(2)(A)] may be a factor. Your evidence may be used in a 

subsequent action against the firm, if corrections are not made.

Consult with your supervisor as soon as possible when you find evidence which meets the criteria set forth in 

CPG 580.100. If you are collecting several samples, the lab should be notified in advance that samples are on 

their way and should be analyzed expeditiously to facilitate regulatory action. Your supervisor may also want to 

notify your compliance branch so evaluation of evidence for a possible mass seizure can commence.

General Guidance for Selective Sampling

When Selective Sampling consists of an actual sample of a product, however small, as distinguished from bag 

cuttings, rodent pellets, insects, etc., a 702(b) portion must be obtained. In such cases, collect duplicate subs of 
EXHBIT 4-22 INVESTIGATIONS OPERATIONS MANUAL 2023 

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the product to provide the 702(b) portion. This 702(b) portion is usually not an exact duplicate of the product 

collected for the Selective Sample, but should be collected from the same bag, box, or other container of 

product sampled. Whether collected from a container or bulk, the 702(b) portion should be taken as close as 

possible to that portion selectively sampled for analysis. Specify for each sub and duplicate collected, the origin, 

manner in which taken, and the examination to be made on your C/R. See IOM 4.3.3.3 

Note: A 702(b) portion is not required for import samples or medical devices. However, if a dispute arises, or a 

potential for regulatory action exists, a 702(b) portion may be collected. Contact your supervisor for additional 

guidance, if necessary.

Submit each portion of bagging or container portion, rodent pellets, material from beneath sampled area, 

control etc., in separate vial or subsample container.

It’s important when collecting a selective sample for adulteration violations that you:

• Use a coherent numbering/identification system for subsamples to avoid unnecessary confusion for the 

lab.

• Provide a detailed listing of individual sub descriptions on the C/R.

• If possible, provide a copy of any maps, photos or other additional documentation to the laboratory.

• Be sure to obtain product labeling. Since samples of lots which are sampled selectively are official 

samples, complete labeling must be collected. See IOM 4.4.9.

Note: Whenever a portion of food is collected as part of a selective sample FD &C Act Section 704(d) applies and 

the C/R should be marked as such.

Documenting Rodent Contamination

The minimum direct reference seizure criteria to assist in assessing rodent adulteration of individual lots, as 

defined in Compliance Policy Guide (CPG) 580.100, are summarized as follows:

The storage facility is rodent infested and: 

• Three or more of the bags in the lot are rodent gnawed; 

Or

• At least five of the bags in the lot bear either rodent urine stains at least 1/4" in diameter, or two 

or more rodent pellets;

Or

• The food in at least one container in the lot contains rodent gnawed material, or rodent excreta 

or urine.

Whether or not the warehouse is rodent infested; IF:

• At least three bags bear rodent urine stains of at least 1/4" in diameter which penetrates to the 

product even though the product cannot be demonstrated to have been contaminated; 

Or

• At least two bags are rodent-gnawed and at least five bags bear either rodent urine stains at 

least 1/4" in diameter, with or without penetration to the product, or two or more rodent pellets; 

Or

• The food in at least one bag in the lot contains rodent-gnawed material or rodent excreta or rodent 

urine, and at least five bags bear either rodent stains at least 1/4" in diameter or two or more rodent 

pellets.
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 4-22 

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Additional regulatory guidance concerning rodent adulteration of pet foods can be found in CPG, 690.600 

Rodent Contaminated Pet Foods.

Examination and Documentation of Rodent Contamination

Examine the exterior of the containers looking for rodent hairs, urine stains, excreta pellets, gnaw 

marks, holes, nesting material and live rodents. Make a diagram of the entire lot and note your findings as 

you examine the individual containers. You will need to include these descriptions on your C/R.

Describe excreta pellets as carefully as possible. Note whether they appear dusty or shiny; soft or 

hard.

Examine suspected urine stains with ultraviolet (UV) light in as near total darkness as possible. A 

minimum of 15 minutes is normally required for the eyes to become properly adjusted to accurately 

differentiate between rodent stain fluorescence and normal fluorescence of rice and certain other 

commodities.

Wet, fresh or continually wetted runs may fluoresce poorly, but the odor of urine will usually be 

present and should be described on the C/R. Fresh dry urine stains will fluoresce blue-white, while 

older stains may be more yellowish/white. Rodent hairs will look like blue/white streaks. Look for the typical 

droplet pattern because rodents commonly urinate while in motion. Report the presence of droplet patterns 

on your C/R.

Urine-stained areas may be photographed under ultraviolet light conditions. Check with your 

supervisor about the technical aspects of this procedure. Do not mark container surfaces to outline 

the stained areas when taking either ultraviolet or normal photographs. This may contaminate the product

by migration through the containers.

A number of things can interfere with the visual identification of urine stains. Many types of bagging 

and threading materials will fluoresce under UV light, however, the characteristic rodent stain fluorescence 

can be identified by its yellowish color and characteristic pattern. In addition, a number of products exhibit a 

natural fluorescence. The following products may be difficult to evaluate because of either natural 

fluorescence or "quenching" of UV rays, even if contaminated. ("Quenching" refers to a covering up or a 

decrease in the ability of a product to fluoresce.)

FOODS

High Gluten Flour (Natural)

Nut Meats (Natural)

Bean Flours (Natural)

Brans (Natural)

Pop & Field Corn (Natural)

Wheat (Natural)

Starch (Natural)

Spices (Natural or Quenching)

NON-FOOD ITEMS

Burlap Bags (Quenching)

Bleached Sacks (Natural-White Glow)

Lubricants (Oils & Greases)

(Natural-Blue/White to yellow/brown glow)

Pitches & Tars (Natural-Yellow)

Detergents & Bleaches (Natural-White)

Sulfide Waste Matter (Natural-Blue/White) 

Note clearly on your C/R if the product or package contains or is directly associated with any of the 

following:

1. Dried milk products (contain urea).
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2. Whole grain wheat (contains urea and allantoin).

3. Animal feeds (urea is usually intentionally added).

Collecting Exhibits or Subsamples fo Rodent Contamination

When sampling lots for rodent contamination, follow the safety precautions in Safety Chapter of the IOM. 

Wear gloves and handle the exhibits with tweezers or forceps. Handle exhibits carefully to prevent loss of 

microscopic evidence. Where you separate, count, or identify the various elements of an exhibit, (e.g.: sieve 

and find X number of rodent pellets), maintain the counted portions separate from the other subs. Note on 

the C/R those subs that were counted, separated, etc.

Collect a representative number of rodent pellets for laboratory confirmation. Place the pellets in a vial or 

other rigid container to prevent crushing. One of the identifying characteristics the lab looks for is the 

presence of rodent hairs in the pellets. The more pellets examined increases the possibility of a good 

identification. However, do not collect all the evidence you see as this would recondition the lot.

Collect portions of urine stains or gnawed holes from containers using small scissors or a sharp 

knife. Leave a portion of the stain or gnawed hole intact but take a cutting large enough to provide good 

identification. Usually 1⁄2 inch around the stain is sufficient to allow manipulation during the lab exam. Note:

The bag cutting should not be so large as to remove the entire contaminated portion, since this would 

recondition the product. For multilayer bags, be sure you cut through all layers of the bag and identify the 

layers with pencil. (Do not use ink as it often contains urea.) If possible, take stained cuttings from areas 

which have not been exposed for extended periods of time to light, in particular, ultraviolet light sources or 

to intense heat. If you have no alternative or cannot determine the stained areas' history, note the 

conditions on the C/R. Place cuttings and gnawed holes between 2 pieces of white paper, and then fold, roll, 

or leave flat and place into a glass container or other suitable container. This will hold the evidence in place 

and prevent possible loss of hairs or parasites due to static charges. Do not separate a multilayer cutting. 

Avoid the use of polyethylene containers as rodent hairs may adhere to containers made from this material. 

Put the cuttings in a large enough container to avoid excessive folding of the cutting.

Collect a minimal amount of product from under the stained area or hole, preferably just clumped product 

as a separate subsample. This prevents dilution of the contaminated product with uncontaminated product. 

Whenever you collect product, regardless of amount, collect a separate subsample to provide a 702(b)

portion. See IOM 4.3.7.4.1. and identify per IOM 4.5.2.1.

Collect nesting material with minimal handling. A half cup is enough for analysis. Do not collect 

any rodents.

Product Control: In addition, you need to collect product controls, in duplicate to provide for the 702(b)

portion. These subsamples should be collected from beneath unstained portions of the container. Collect 

control samples from 3 different containers.

Packaging Control: Collect a portion of unstained container, which does not fluoresce, as a separate 

subsample for a control. As a general guide, collect the controls from the opposite side of the bag or make 

the cutting large enough to separate the control area and the stain. Separate the controls from the stains 

and submit in separate containers. Collect at least 3 container controls for each sample. If the lot consists of 

different containers or bags of different manufacturers, collect controls to represent each type or 

manufacturer of the containers.

Submit each portion of bagging or container, pellets, material from beneath sampled area, control, etc., 

in separate vial or subsample container. Place the subsamples in a dark container, such as a cardboard box 

to protect them from light and protect the exhibits from being crushed.
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 4-22 

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Summary of Sample for Rodent Evidence

The complete official sample will consist of: 

1. Subsamples of rodent excreta pellets. 

2. Subsample of nesting material. 

3. Subsamples of stained bagging, or portions of the containers, and any adhering pellets.

4. Subsamples of unstained bagging, or portions of the containers, which do not fluoresce, for 

controls (minimum three required).

5. Subsamples of small portions of the product from directly beneath the stained areas. Do not 

dilute the contaminated product beneath the stain with the non-contaminated product.

6. Subsamples of small portions of product to serve as 702(b) portions

7. Subsamples of uncontaminated product from beneath the unstained bagging, or other 

container. These serve as controls and should be collected in duplicate to provide 702(b) portions. 

Collect control samples from 3 different containers.

8. Subsamples of cuttings from gnawed holes.

9. Subsamples of small amounts of product collected from beneath the gnawed holes.

10. Subsamples of small portions of product to serve as 702(b) portions.

11. Product labeling.

12. Interstate documentation.

If conditions warrant, consider collecting an INV sample per IOM 4.1.6. to document widespread rodent 

activity. 

Documenting Insect Contamination

The criteria from CPG 580.100 below, involving dead insects only, will not be used for action against any food 

intended to undergo further processing that effectively removes all the dead insects, e.g., processing of cocoa 

beans.

The product contains:

• One live insect in each of two or more immediate containers; or, one dead insect in each of 

three or more immediate containers; or, three live or dead insects in one immediate container; 

plus

• Similar live or dead insect infestation present on, or in the immediate proximity of, the lot to 

show a 402(a)(4) [21 U.S.C. 342 (a)(4)] violation.

Or:

• The product contains one or more live insects in each of three or more immediate containers.

Or:

• The product contains two or more dead whole insects in at least five of the immediate 

containers. Note: a situation such as this may follow fumigation of the lot and vacuuming of the 

exteriors of the bags.

Or:

• The product is in cloth or burlap bags and two or more live or dead insects are present on at least 

five of the containers. 
EXHBIT 4-22 INVESTIGATIONS OPERATIONS MANUAL 2023 

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Note: Some live insects must be present. Product need not be shown to have become contaminated.

Examination and Documentation of Insect Contamination

Examine the exterior of the containers (especially along seams or creases) looking for insects, 

larvae, webbing, nesting material, entrance or exit holes, and cast skins. Make a diagram of the 

entire lot and note your findings as you examine the individual containers. Describe insects or larvae 

carefully, noting if they are dead or alive. You will need to include these descriptions on your C/R.

Collecting Exhibits or Subsamples of Insect Contamination

Collect a representative number of insects for laboratory confirmation. Consider the use of a 

moistened artist brush to collect subsamples. Place the specimens in a vial or other rigid container to 

prevent crushing. Collect all forms of insects you see, however do not collect all the evidence from the lot or 

you might recondition the product. If you collect live insects, be sure to note that on your C/R. However, you 

should not send live insects to the lab. Freeze the subsamples prior to shipment to ensure they are not alive 

when you ship them. Note the fact that the subsamples were frozen on the C/R.

Cut portions of bags or containers containing suspected insect entrance or exit holes from 

containers using small scissors. Usually 1⁄2 inch around the holes is sufficient to allow manipulation 

during the lab exam. Note: The bag cutting should not be so large as to remove the entire 

contaminated portion, since this would recondition the product. For multilayer bags, be sure you cut 

through all layers of the bag and identify the layers with pencil. (Do not use ink as it often contains urea.) 

Place cuttings between 2 pieces of white paper, and then fold, roll, or leave flat and place into a glass 

container or other suitable container. This will hold the evidence in place and prevent possible loss 

microscopic evidence due to static charges. Do not separate a multilayer cutting. Avoid the use of 

polyethylene containers as insect fragments may adhere to containers made from this material. Put the 

cuttings in a large enough container to avoid excessive folding of the cutting

Collect product from beneath holes which penetrate the packaging as a separate subsample. Whenever 

you collect product, regardless of amount, collect a separate subsample to provide a 702(b) portion. Note 

on the subsample itself and on your C/R which subsamples are the 702(b) portions.

Summary of Sample for Insect Evidence

The complete official sample will consist of:

8. Subsamples of insects, larvae, webbing, etc.

9. Subsamples of portions of the containers with entrance or exit holes.

10. Subsamples of small portions of the product from directly beneath holes.

11. Subsamples of small portions of product serve as 702(b) portions See IOM 4.3.7.4.1.

12. Product labeling.

13. Interstate documentation.

If conditions warrant, consider collecting an INV sample per IOM 4.1.6. to document widespread insect 

activity. 

Documenting Bird/Avian Contamination

Per the criteria from CPG 580.100, if the product is in permeable containers (paper, cloth, burlap, etc.), and

• The product contains bird excreta in one or more containers, and you feel the insanitary storage 

conditions will clearly support a 402(a)(4) [21 U.S.C. 342 (a)(4)] violation
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 4-22 

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Or

• Bird excreta is present on the exteriors of at least five of the containers, and the product contains 

bird excreta in one.

Or

• At least 30% of the number of bags examined, but at least five bags, are contaminated with bird 

excreta; and at least three of the bags bear excreta stains which penetrate to the product, even 

though the product may not be contaminated.

Note: In all instances of bird excreta contamination the excreta must be confirmed by positive test for uric 

acid.

Examination and Documentation of Bird Contamination

Examine the exterior of the containers looking for bird excreta. Make a diagram of the entire lot and 

note your findings as you examine the individual containers. You will need to include these descriptions on 

your C/R.

Collecting Exhibits and Subsamples

Remove portions of bird excreta stains from containers using small scissors. Leave a portion of the 

stain intact but take a cutting large enough to provide good identification. Usually 1⁄2 inch around the 

stain is sufficient to allow manipulation during the lab exam. Note: The bag cutting should not be so large as 

to remove the entire contaminated portion, since this would recondition the product. For multilayer bags, 

be sure you cut through all layers of the bag and identify the layers with pencil. (Do not use ink as it often 

contains urea.) If possible, take stained cuttings from areas which have not been exposed for extended 

periods of time to light, in particular, ultraviolet light sources or to intense heat. If you have no alternative or 

cannot determine the stained areas' history, note the conditions on the C/R. Place cuttings between 2 pieces 

of white paper, and then fold, roll, or leave flat and place into a glass container or other suitable container. 

This will hold the evidence in place and prevent possible loss of microscopic evidence due to static charges. 

Do not separate a multilayer cutting. Avoid the use of polyethylene containers as bird excreta may adhere to 

containers made from this material. Put the cuttings in a large enough container to avoid excessive folding 

of the cutting.

Collect a minimal amount of product from under the stained area, preferably just the clumped product as 

a separate subsample. This prevents dilution of the contaminated product with uncontaminated product. 

Collect a separate subsample to provide a 702(b) portion (See IOM 4.3.7.4.1).

Product Control: In addition, you need to collect product controls, in duplicate, to provide for the 702(b)

portion. These subsamples should be collected from beneath unstained portions of the container. Collect 

control samples from 3 different containers.

Identify the 702(b) subsamples, as such on subsample identification (See IOM 4.5.2.1.) Note on the 

subsample itself and on your C/R which subsamples are the 702(b) portions.

Packaging Control: Collect a portion of unstained container as a separate subsample for a control. As a 

general guide, collect the controls from the opposite side of the bag or make the cutting large enough to 

separate the control area and the stain. Separate the controls from the stains and submit in separate 

containers. Collect at least 3 container controls for each sample. If the lot consists of different containers or 

bags of different manufacturers, collect controls to represent each type or manufacturer of the containers.

Summary of Sample for Bird Evidence

The complete official sample will consist of:
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1. Subsamples of stained bagging, or portions of the containers.

2. Subsamples of unstained bagging, or portions of the containers for controls (minimum three 

required).

3. Subsamples of small portions of the product from directly beneath the stained areas. Do not dilute 

the contaminated product beneath the stain with the non-contaminated product.

4. Subsamples of small portions of product to serve as 702(b) portions.

5. Subsamples of uncontaminated product from beneath the unstained bagging, or other container. 

These serve as controls and should be collected in duplicate to provide 702(b) portions. Collect control 

samples from 3 different containers.

Submit each portion of bagging or container portion, pellets, material from beneath sampled area, 

control, etc., in separate vial or subsample container.

6. Product labeling.

7. Interstate documentation.

Documenting Chemical Contamination

Collect samples from lots suspected of dry chemical contamination in much the same manner as described for 

rodent urine. After collecting a sample of the contents from immediately beneath the suspected area, collect 

residues from the surface of the bag or container. In the case of infiltration of loosely woven bags, shake or 

tumble the bag over a large sheet of clean paper to collect the siftings as a sample.

Documenting Mold Contamination

The USDA/FGIS has approved a number of commercial screening tests for detecting aflatoxin contaminated 

corn. However, these tests usually require a chemical extraction process and are therefore not amenable to FDA 

field examination procedures.

The black light test (also referred to as the Bright Greenish-Yellow Fluorescence (BGYF) test) is a 

presumptive test used to screen and identify corn lots that should be tested further for aflatoxins. The test is 

based on BGYF observed under long wave (366 nm) ultraviolet (UV) light produced by the molds Aspergillus 

parasiticus and A. flavus on "living" corn (i.e. corn that has been stored less than 3 months). The growth of these 

fungi may result in aflatoxin production. Aflatoxins per se do not produce BGYF under long wave UV light. It is 

thought the BGYF is produced by the reaction of kojic acid formed by the fungi and a peroxidase enzyme from 

living corn. Corn that has been in storage for a lengthy period of time (3 months or more) may give false positive 

BGYF. Therefore, determine how long the corn being sampled has been in storage. If it has been in storage over 

three months, do not use the following field screening procedure.

Essential steps for this black light procedure are:

• A 10 lb. sample representative of the corn lot must be obtained by probing, or by continuously 

sampling a grain stream.

• Examine using a 366 nm UV light (portable black-lights meet this criteria).

• Wear goggles or use a viewer that screens out UV light. Shine the light on the corn sample

which has been spread in a single layer on a flat surface in a darkened room.

• Use a 2 lb. portion, and carefully observe the entire corn surface one kernel at a time. Examine the 

entire sample using this procedure.

• Count all BGYF glowers (kernels or particles that "glow" bright greenish-yellow). Compare the 

BGYF color with a fluorescent standard, if one is available. Normal corn, if it fluoresces, will 

fluoresce a bluish white.
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 4-22 

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If four (4) or more BGYF particles are detected in the 10 lb screening sample, collect a sample for 

laboratory analysis.
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4-23 – AFFIDAVIT – FDA 463a 
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 4-23 

4-161
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INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 4-24 

4-163

4-24 – HQ LABS 

Laboratory/Center Commodity/Sample

Types

Special Directions Address

Center for Drug Evaluation 

and Research (CDER) 

Drugs • Do not forward original C/R 

and records. 

• Enclose a copy of the 

assignment memorandum in 

the FDA 525 envelope. 

• Affix the FDA 525 to the 

officially sealed sample

package. 

• Submit the Original C/R and 

records to the home division, 

or forward to the home 

division if other than the 

collecting division.

Office of Testing and 

Research, Office of 

Pharmaceutical Quality, 

Food and Drug

Administration, 645 S. 

Newstead Ave., St. Louis, 

MO, 63110, USA

Center for Food Safety and 

Applied Nutrition (CFSAN)

• Office of Regulatory 

Science 

o Division of 

Bioanalytical 

Chemistry (HFS-715)

Food

• Elemental Analysis

• Natural Toxins

• Nutrients

Dietary Supplements

• Ingredients

• Elemental Analysis

• Natural Toxins

Cosmetics

• Ingredients

• Elemental Analysis

• Natural Toxins

Conducts laboratory 

investigations in the broad areas 

of elemental analysis, natural 

toxins, nutrients in food, 

ingredients in dietary 

supplements, and ingredients of 

cosmetics.

Food and Drug

Administration 

5100 Paint Branch 

Parkway 

College Park, Maryland 

20740

CFSAN

• Office of Regulatory 

Science 

o Division of Analytical 

Chemistry (HFS-705)

• Food Additives

• Allergens,

• Pesticides

• Dietary Supplements

• Seafood Toxins

• Food Defense Threat 

Agents

• Industrial Chemical 

Conducts laboratory 

investigations in the broad areas 

of food additives, allergens, 

pesticides, dietary supplements, 

seafood toxins, food defense 

threat agents, and industrial 

chemicals that may contaminate 

CFSAN regulated products

Food and Drug

Administration 

5100 Paint Branch 

Parkway 

College Park, Maryland 

20740
EXHBIT 4-24 INVESTIGATIONS OPERATIONS MANUAL 2023

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CFSAN

• Office of Regulatory 

Science 

o Division of 

Microbiology (HFS710)

Pathogens and Toxins 

in: 

• Food

• Cosmetics

Also: 

Pathogens and Toxins 

from the processing 

environment of food 

and cosmetic facilities.

Develops, optimizes, and 

validates methods for recovery, 

detection, identification, and 

quantitation of pathogens and 

toxins from foods and cosmetics, 

and the processing environment. 

Maintains FDA's food-related 

gateway to the PulseNet System. 

Develops and applies subtyping 

methods to further enhance data 

generated for Pulsenet, strain 

identification, and molecular 

epidemiological investigations.

Food and Drug

Administration 

5100 Paint Branch 

Parkway 

College Park, Maryland 

20740

CFSAN

• Office of Applied 

Research and Safety

Assessment

o Division of Molecular 

Biology (HFS-025)

Food,

• For Chemical or 

specialized 

equipment or skills 

needed for analysis

Food Packaging 

Materials

Microbiological – Food 

Pathogens by rapid 

methods

Analyzes foods when the 

chemical methodology is under 

development or unusual 

equipment or skills are required, 

such as radioactivity analysis and 

migration of food additives from 

food packaging materials. 

Microbiologically examines 

samples for potential food 

pathogens by rapid molecular 

biological testing using DNA 

probes, PCR, and DNA 

fingerprint analysis.

Food and Drug

Administration 

5100 Paint Branch

Parkway 

College Park, Maryland 

20740

CFSAN

• Office of Cosmetics and 

Colors

o Division of Color 

Certification and 

Technology (HFS-105)

Color Additive 

Samples for Food, 

Cosmetics

Conducts analyses of color 

additive samples submitted to 

FDA for certification, assigns 

certification lot numbers to 

compliant lots, and denies 

certification to non-compliant 

lots. 

Develops, optimizes, and 

validates methods for the 

determination of components and 

impurities in certifiable color 

additives. 

Develops, optimizes, and 

validates methods for the 

determination of color additives 

in foods and cosmetics. Conducts 

analyses of foods and cosmetics 

for color additive content when 

special skills and expertise are not 

available in the field.

Food and Drug

Administration 

5100 Paint Branch 

Parkway 

College Park, Maryland 

20740
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 4-24 

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CFSAN

• Office of Food Safety

o Division of Seafood 

Science and 

Technology, Gulf 

Coast Seafood 

Laboratory (HFS-400)

Fish means fresh or 

saltwater finfish,

crustaceans, other 

forms of aquatic animal 

life including, but not 

limited to, alligator, 

frog, aquatic turtle, 

jellyfish, sea cucumber, 

and sea urchin and the 

roe of such animals 

other than birds or 

mammals, and all 

mollusks, where such 

animal life is intended 

for human 

consumption.

• microbiological and 

chemical

• bacterial and viral

pathogen,

• natural marine 

toxins,

• aquaculture drugs

• products of 

decomposition

Conducts microbiological and 

chemical investigation of seafood, 

including bacterial and viral

pathogen, natural marine toxins, 

aquaculture drugs, products of 

decomposition, and other 

contaminants when special skills 

or equipment required for analysis 

are not available in the field.

FDA Gulf Coast Seafood 

Laboratory 

Iberville Drive 

Dauphin Island, AL 36528

Center For Drug Evaluation 

and Research

• Division Of 

Pharmaceutical Analysis 

(DPA)

Surveillance drug 

samples

• All heparin and 

insulin samples.

Examines surveillance drug 

samples collected and shipped 

under current program directives. 

Analyzes all heparin and insulin 

samples.

CDER-OPS-OTR 

Division of Pharmaceutical 

Analysis (DPA) 

645 S. Newstead, Ave. 

St. Louis, MO 63110

Center For Biologics 

Evaluation and Research 

(CBER)

Biological products Examines and reviews biological 

products not covered by a 

Compliance Program. 

Prior to shipping a sample, the 

division should notify either the 

Sample Custodian, 301-594-6517, 

or the Regulations and Policy 

Branch, 301-827-6210, who in 

turn will notify the Sample 

Custodian.

Sample Custodian 

Center for Biologics 

Evaluation and Research 

Food and Drug

Administration 

10903 New Hampshire 

Avenue 

WO75-G707 

Silver Spring, MD 20993-

0002
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Center For Devices and 

Radiological Health 

(CDRH)

• Bioburden analysis

• Bioindicator analysis

• Device and GWQAP 

device samples for 

physical and 

engineering analysis

• in-vitro diagnostic 

device

• Antibiotic 

susceptibility testing 

(including discs) 

requiring 

performance testing 

WEAC is the primary 

laboratory for devices and 

radiation-emitting products. 

The CDRH Office of Science 

and Engineering Laboratories 

accepts medical devices and 

radiation-emitting products 

for testing, but only after 

assignment or approval from 

CDRH, Office Health 

Technology

WEAC 

109 Holton Street (HFRNE400) 

Winchester, MA 01890-

1197 

Patrick Regan, Director, 

Analytical 

Telephone: 781-756-9707 

FAX: 781-756-9757

CDRH Condom and Glove 

Samples

Send Southwest and Pacific 

Region condom and glove 

samples to the Pacific Regional 

Laboratory (PRS) 

Send all other condom and glove 

samples to WEAC.

Pacific Regional 

Laboratory (PRS)

/Pacific Southwest 

Laboratory 

19701 Fairchild Irvine, CA 

92612

WEAC 

109 Holton Street (HFRNE400) 

Winchester, MA 01890-

1197 

Patrick Regan, Director, 

Analytical 

Telephone: 781-756-9707 

FAX: 781-756-9757

CDRH Radiological health 

samples

Send radiological health samples 

to: 

CDRH/OSEL Sample Custodian 

HFZ-105 

WO62, 10903 New Hampshire 

Ave,, Room 4126 

Silver Spring, MD 20993 

Telephone: 301-796-2558 

FAX: 301-796-9795 

Note: Contact Office of Science 

and Engineering Laboratories, 

301-796-2558 prior to collection

and shipment of any radiological 

product sample.

CDRH/OSEL Sample

Custodian HFZ-105 

WO62, 10903 New 

Hampshire Ave,, Room 

4126 

Silver Spring, MD 20993 

Telephone: 301-796-2558 

FAX: 301-796-9795
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 4-24 

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Center for Veterinary 

Medicine (CVM)

Samples of veterinary 

products, including 

documentary samples, 

and labels/ labeling and 

advertising materials

Samples of veterinary products, 

not specifically covered by one or 

more of the CVM Compliance 

Programs.

There are no laboratory facilities 

at MPN II. If you have questions 

about sampling or sample 

destinations, contact HFV-230 

and/or the applicable program 

contact.

Center for Veterinary 

Medicine 

Division of Compliance 

(HFV-230) 

7500 Standish Place (MPN 

II) 

Rockville, MD 20855

Center for Tobacco 

Products (CTP)

Tobacco products 

• Both compliance and 

surveillance samples

Do not collect samples of tobacco 

products unless directed by an 

assignment, approved by the 

Center for Tobacco Products, 

Office of Compliance and 

Enforcement, or by Division 

Management

Southeast Regional 

Laboratory (SRL), Atlanta 

Center for Tobacco 

Analysis.
EXHBIT 4-25 INVESTIGATIONS OPERATIONS MANUAL 2023 

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4-25 C/R DATA ELEMENTS IN ORDER OF ENTRY INTO FACTS 

This exhibit, which was derived from OBIMO work instructions, attempts to clarify entry of data into FACTS for a 

sample collection report. This exhibit, which presents C/R data elements in order of entry into FACTS from left 

to right and top to bottom, can assist the collector if used while completing the C/R. This exhibit includes 

information from IOM chapter 4 (Sampling) and clarifying remarks added in italicized font where needed. See 

IOM 4.6.2 for an alphabetized list of data elements. 

FACTS Page 1

Sample Number: Select a pre-assigned sample number, using the list of values button, or the system will enter a 

sample number when the record is saved. 

Select the number you identified your sample with. This number comes from the group of sample 

numbers you previously generated in FACTS.

Sample Class: Make a selection from the following list of values: "Collaborative Study"; "Criminal Investigation"; 

"District Use Sample"; "Normal Everyday Sample"; "Petition Validation"; "Quality Assurance"; "State 

Partnership"; "Total Diet." 

Normal Everyday Sample is the typical choice here. If you have something other than a Normal Everyday 

Sample, your assignment will indicate that and you should select the appropriate choice.

Sampling Organization: Make a selection from the list of values. This is the division which actually collects the 

sample. 

Typically, this is your home division e.g., BIMOW.

Collection Date: Enter the date using the format - mm/dd/yyyy. Note: the default date is today's date. Be 

careful not to use the default date if the sample was not collected on the date the CR is created. Only one 

date can be entered; if the sample collection was accomplished over several days, use one date. Be 

consistent. This date should be used to identify the physical sample and any records attached to the C/R.

Be sure to verify the date appearing in this field as above. Assure the date is the actual date collected. 

Slow down! This is a critical field.

Lot Size: Enter the amount of goods on hand before sampling as determined by your inventory of the lot. 

Include the number of shipping cases and the size of the components, e.g., 75 (48/12 oz.) cases, 250/100 lb. 

burlap bags, 4/100,000 tab drums, 24 cases containing 48/12/3 oz. tins. If accompanying literature is involved, 

describe and state the amount on hand. For DOC samples (see Exhibit 4-1 and 4-2), also indicate the lot size, 

e.g., "one x-ray machine" or "50000 syringes and 1000 promotional brochures." 

State the size of the lot going from the largest unit to smallest, i.e., from shipping case to immediate 

container. 
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 4-25 

4-169

Sample Origin: Choose "Domestic" or "Domestic/Import" from the list of values. 

If the product was imported into the United States and has been released for distribution in Interstate

Commerce, it is a Domestic/Import. Domestic samples come from products produced in the United 

States. For bioequivalence samples collected during foreign inspections at foreign Dealers, select 

Domestic/Import. Although these samples are not being collected from a lot of product which has 

passed through US Customs and entered domestic commerce, there is currently no Operation Code for a 

foreign sample.

Sample Basis: Choose the appropriate value from the list. Values have been changed to differentiate between 

environmental samples and other samples. Compliance = collected on a selective basis, complaint, evidence

that there may be a problem, “for cause”; Surveillance = objective basis. For environmental samples, select 

Environ–Compl for compliance samples or Environ–Survl for surveillance samples. The Other–Compl and OtherSurvl basis values are used for all other samples. Official and INV samples can both be either Surveillance or 

Compliance.

Select from the two choices on the list of values. "Compliance" means the sample was collected on a selective

basis as the result of an inspection, complaint, or other evidence of a problem with the product. "Surveillance" 

means the sample was collected on an objective basis where there is no inspectional or other evidence of a 

problem with the product. Please note official samples can be either compliance or surveillance, and INV

samples can also be either. See IOM Exhibit 4-16 for more information.

Note: When you have observed a violation and this sample is collected as evidence, it is a Compliance 

Sample. When you have not observed a violation, but are simply collecting a sample at random, such as 

a bioequivalence sample for drug assay, that is a Surveillance Sample.

Sample Type: Make a selection from the list of values. You can enter only one value. If more than one type 

applies, choose one and indicate the other in remarks. If the sample is a domestic import, be sure to enter "DI", 

so that you can enter the foreign manufacturer. 

The sample type for all bioequivalence samples will be “Official”. Select “Domestic-Import” if applicable. Note: 

Domestic-Import samples are also Official, however, this is the way the drop-down menu is set up. See IOM 

4.5.3. 

Consult IOM 4.4.10.2.4 and your supervisor to choose the correct Sample Type. This field is actually a 

part of your sample number. For example, if you collect a Domestic Import Sample, you add the prefix 

“DI” to your number so that you identify the sample as “DI 123321.” Another example is investigational 

samples, which are collected to document observations such as rodent infestation and/or where 

interstate commerce does not exist or is not necessary. Filth Exhibits are always investigational samples 

and would be identified as "INV 123321."

FIS Sample Number: Enter the last two digits of the fiscal year. The remainder of the number will be assigned by 

FACTS. Note: FIS sample numbers will no longer be required when the FIS is turned off. 

For FY 2009 enter 09. FIS is the Field Information System. That system predates FACTS and is still in use 

for some laboratory operations.
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Episode Number: Enter an episode number if applicable. 

Pesticide Episode - An "episode" is defined as a violative pesticide (or other chemical contaminant) 

finding and all samples collected in follow-up to that finding. All samples must be associated with one 

responsible firm (grower, pesticide applicator, etc.) and one specific time period (e.g., growing season). 

The Episode Number will be the sample number of the first violative sample collected in a series of 

samples and is used to identify the other related samples within an episode. The divison must assure that 

the Episode Number is used within the divison and any other divisons which follow-up to the original 

violative sample. This number must appear in the Episode Number field of the FACTS CR. See IOM 

4.6.2.27.8 for examples.

Related Sample: This field is used to identify a sample number to which other sample information can be linked. 

When you collect more than one sample from a single shipment or there is more than one sample relating to a 

possible regulatory action, designate one sample as the "lead" sample. Enter that sample number in this field of 

the collection record for each related sample. Other related sample numbers should be listed in the Collection 

Remarks field. 

The lead sample number is typically the first sample collected. For example, in a violative sanitation 

inspection you will most likely collect multiple samples. These samples could include samples of product

defiled by rodents (including gnawed cardboard cases, urine stained bag cuttings, product located 

directly beneath urine stains, product randomly sampled throughout the lot, photographs, diagrams of 

lot, etc.) and filth exhibits (which can include rodent droppings, insect casings, nesting materials, etc.). 

Designate your first sample as the lead and list this number in the Related Samples field for all other 

samples collected during the inspection. Note that for the lead sample, this field will be blank. For all 

other samples where there are not related samples, e.g., a single sample collected, this field will be 

blank.

Sample Description: Briefly describe what the sample consists of, i.e., three unopened, 200 tablet bottles; 20 lb. 

case of iceberg lettuce; or documentary sample consisting of records, literature, and photographs, etc. 

Ensure that the field includes a description of the investigational product collected as well as the reference and 

placebo if applicable.

A statement such as, “Sample consists of retention sample for protocol GDC-695-001 consisting of one 

block containing three total 100g tubes: GDC 695 Gel (kit 1217), Diclofenac Sodium Gel (kit 1219), and 

Vehicle Gel (kit 1218).” Labeling, documents (including those other than I/S records) or photos, are also 

described here. For DOC samples you will state that the sample consists of photos, records and observed 

GMP deficiencies. Include anything here collected to document the violation.

Collection Reason: Enter the complete reason for collection giving the suspected violation, compliance program 

guidance manual, and analysis desired. Identify any interdistrict, regional, headquarters initiated, assignment 

document(s) in sufficient detail so the document can be located, if necessary. If the sample was collected during 

an inspection to document violations found, state that and indicate the date of inspection. See IOM Exhibits 4-1 

and 4-16. 

Reference the compliance program (e.g., CP 7348.003, “In vivo Bioavailability- Bioequivalence Studies- Clinical”, 

the assignment memo, and the inspection dates (if applicable). There will not be a suspected violation for 

surveillance samples. Add the following statement and edit as appropriate, “Sample of bioequivalence 
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investigational product, reference control and placebo. Sample is representative of test product used in study 

supporting Protocol (insert Study #).” You will specify the analysis desired as follows: “Collected for drug assay 

analysis.” Include the application number, e.g., ANDA 12345. 

Note there are four pieces of information to report for the Collection Reason. 1) Whether sample was 

collected during and inspection of the Dealer. 2) The Compliance Program and assignment is applicable. 

3) The suspected violation. 4) What analysis is desired. For example, the Collection Reason could be 

completed as, “Sample of bioequivalence investigational product, reference control and placebo

collected during EI of Dealer 10/01/2022. Sample is representative of test product used in study 

supporting Protocol VBD-1212 under ANDA 12345. Collected pursuant to FACTS Assignment #188118 

and in accordance with CP 7348.004. Collected for drug assay analysis.”

Collection Remarks: Enter any remarks you feel are necessary. Describe any special circumstances. If a 704(d) 

[21 U.S.C. 374(d)] letter is indicated, include the name, title, E-mail address (if available) and the telephone/fax 

number of the most responsible person at the firm to which the letter should be addressed. If a 702(b) sample is 

not collected, describe the specific circumstance and justification for not collecting the 702(b) portion unless it is 

a device or tobacco product, or the assignment or guide already states why a 702(b) portion is not needed. If the 

sample is an in-transit sample, state the sample was collected in-transit, from whom sampled (e.g. driver and 

carrier firm), and where sampled. If the dealer firm is a consumer, the name and address of the consumer 

should be entered in the Collection Remarks field, and the consumer's state in the State field. You may use a "CR

Continuation Sheet", FDA 464a if you need more space.

Note: Confirmation of firm Email address and inclusion in collection remarks is integral in order to provide 

results in an efficient and timely manner. According to Field Management Directive (FMD) 147, if the firm has 

agreed to hold products pending FDA results or if the analytical results are laboratory classification 3, the 

Laboratory Director or their designee shall email the results of analysis to the collecting division’s established 

email account for receipt of analytical results.

Include any additional information required to fully explain the collection. This field is also used to 

describe chain of custody when necessary e.g., describing what conditions the sample was held under 

until submitted to the laboratory. The CR Continuation Sheet is used when you have a lot of information 

to share, such as describing GMP deficiencies, observations, or sub-samples. In the case of a food firm 

where you have collected multiple subs to document filth conditions or environmental swab samples, 

you’ll want to describe each sub, where it was collected, what it consists of, etc. This will be extremely 

important information when Compliance is reviewing the sample results and your report for any 

regulatory follow-up.

Associated Firms Section

Resp. Firm Type: Choose the appropriate type from the list of values for the firm most likely to be responsible 

for a violation. For a 301(k) [21 U.S.C. 331(k)] sample the responsible firm should be "Dealer". You should only 

enter one firm with the firm type you designate as the responsible firm type. 

This designation requires some thought on the collector’s part. Think about the violation you are 

documenting. Who caused the product to become adulterated? The example of a 301(k) sample listed 

above says to select the Dealer as the Responsible firm. This is because of the definition of a 301(k) 

violation. 301(k) prohibits the adulteration of a product after shipment in interstate commerce. 

Therefore, the Dealer caused the adulteration sometime after receipt in interstate commerce. When you 
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are documenting a 301(a) violation, shipment of an adulterated product in interstate commerce, your 

responsible firm will be the firm shipping the adulterated product or causing the shipment of the 

adulterated product. It can be the Manufacturer, or it can be the Dealer. A little thought on what you 

are documenting will make this designation clear.

Dealer is Consumer? Note: If the dealer firm is a consumer, the name and address of the consumer should be 

entered in the Collection Remarks field, and the consumer's state in the State field. When the sample is an intransit sample (see IOM 4.1.4.2.1), enter the consignee of the lot as the dealer and state in collection remarks 

the sample was collected in-transit, from whom sampled (e.g., driver and carrier firm), and where sampled.

Commonly used for Consumer Complaint samples when you collect a sample from the complainant. Be 

sure to consult with your supervisor prior to collecting samples from a complainant.

FEI Number: The FEI number is a 10-digit unique identifier, which is used to identify firms associated with FDA 

regulated products. Use the Build button to query the database and find an FEI for firms associated with your 

sample. If one does not exist, FACTS will assign one to the firm. Take care in entering search criteria to avoid 

creating unnecessary FEI numbers. You must enter an FEI for a dealer on every CR, unless you check the box 

indicating the dealer is a consumer.

When selecting the FEI, be very careful to select the correct firm. Some tips: compare the street 

addresses of firms retrieved by the search, look for firms that are Workload Obligation = Y and 

Operational Status = OPR, if your firm is not returned by your first search don’t give up, try different 

criteria. More often than not, we will be collecting samples from firms that we have been to before. 

However, if it’s a new firm you will need to add that firm and notify the OEI Coordinator or your 

supervisor. We want to assure we do not add duplicate firms into the FACTS OEI, thus maintaining the 

accuracy of the OEI.

Product Section

Product Code: Enter the 7-digit product code. Use the Product Code Builder for guidance. When 301(k) samples 

are collected, the full product code of the finished product must be entered. See IOM exhibit 4-1. See IOM 

4.6.2.27.7 for product codes for filth or evidence exhibits. Special product code considerations include 

environmental samples. See environmental sample identification instructions under IOM 4.3.6.6.2.

A tip for building a product code within FACTS or Product Code Builder: Enter the name of the product in 

the Product Name field and click on ExeQry (Execute Query). This will return a list of products containing 

that text for you to select from and continue to build the code.

Brand Name: Enter the Brand Name of the product. This is found on the labeling of the product. It is important 

to identify the product completely so the compliance officer can communicate accurate information to the court 

and the U.S. Marshal in the event of a seizure. 

Typically found on the labeling of the product such as, “Blue Bunny” carrots. Sometimes in the case of 

DOC samples for medical devices you may need to dig a little to find out if there is a brand name.
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Product Description: Enter a complete description of the product including the common or usual name and the 

product packaging/container system. For example, aspirin tablets packed in clear, non-flexible plastic bottle with 

white screw on top with yellow stick-on label and black printing. Bottles packed in white, paperboard boxes with 

black printing. Paperboard boxes packed in brown cardboard boxes with black printing. If you need additional 

space, continue the description in remarks. See IOM exhibit 4-1.

Completely describe the product and how it is packaged and packed in shipping containers as 

appropriate. Note that you go from the product to the outer most layer of packaging.

Product Label: Quote pertinent portions of the label such as brand name, generic name, quantity of contents, 

name and address of manufacturer or distributor, code, etc. In the case of drugs, quote the potency, active 

ingredients and indicate whether Rx or non-Rx. Quote sufficiently from accompanying literature to identify. In 

the case of a Documentary Sample, sufficiently describe the article to identify what is sampled.

NOTE: When the product sampled is packaged in a carton, shipping case or similar container, quote the 

pertinent labeling from the container.

When quoting from a label, or labeling, use exact spelling, capitalization, punctuation, arrangement, etc., as 

found on the original label(ing). Use asterisks to indicate any omissions.

The label quote shall be an exact quote of the label. Use the same upper and lower case letters, 

misspellings would be quoted as appearing on the label. Start with the principal display panel and work 

your way top to bottom then left to right around the label. For ingredient listings, include any suspect 

ingredient and major ingredients. Use *** to show omissions of text and graphics. As an example, the 

sampled product bears an adhesive label which reads in part, “Walgreens *** Deluxe Mixed Nuts No 

Peanuts Net Wt 10 OZ(283g) *** INGREDIENTS: Cashews, Almonds, Brazil Nuts, Filberts, Pecans, *** 

Distributed by: Walgreen Co. Deerfield, IL 60015-4616 ***". Do not use asterisks to indicate a new line 

of label or panel of the label. Only use asterisks to indicate you have left something out.

Documents Obtained: Click on the "Documents Obtained” button to enter Document Type, Document Number, 

Document Date and Remarks for any records collected to support a violation or show interstate movement of 

the product sampled. Enter an identifying number and date for invoices, freight bills, bills of lading, etc. Include 

the name and title of person signing any affidavits in the Remarks field. Be sure to describe the reason each 

document attached to the collection record was obtained. For example, when referring to a bill of lading, 

indicate that it was collected to document the interstate movement of the product. Also indicate which 

documents were collected to document specific violations encountered during inspections. State the number of 

pages for each document if it contains more than one page and refer the reader to the appropriate section/page 

of the document which shows the deviation you are documenting. Indicate the number of photographs

attached. Depending on the sample and what you are trying to document, you may use the document number 

to record the actual number of the document (i.e., invoice number or bill of lading number) or to order the 

documents attached. You should order your documents in a manner that allows easy review (be guided by your 

supervisor or Compliance Branch). This section may also be used to list C/R attachments including FDA 

generated forms. See IOM exhibit 4-1. 

Remember that documents attached to the C/R are to be identified with the sample number, date of 

collection and collector’s initials.
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Manufacturing Codes: Click on the “Manufacturing Codes” button to enter and identify all codes, lot numbers, 

batch control codes, etc., and how they are displayed on labels, cartons, and shipping containers. Enclose the 

code in quotes, e.g., "code". For example, code embossed on can cover, "87657888" or code applied in ink on 

side of carton, "0987878". Also indicate the manufacturing codes used on products for which a DOC sample was 

collected, for example, "serial number "ABC" stamped on metal ID plate." See IOM Exhibit 4-2.

Enter any expiration dates in the Exp Date field.

Be sure to define what the code is e.g., lot number, batch number, serial number, production date, etc. If 

a two line code is employed by the manufacturer (such as with many canned products), it may be 

expressed like “12345AGB / GAV45833,” where the slash indicates a separate line code.

Sample Flags: Click on the “Sample Flags” button to choose an appropriate flag using the list of values. See 

4.6.2.27 and exhibit 4-15. 

IOM 4.6.2.27 contains a listing and description of Sample Flags. These are used to alert the reader of 

your C/R what the sample is documenting if further clarification is necessary. The Sample Flag will be 

printed at the top of your hard copy C/R. For example, when you collect a 301(k) sample, the flag will 

indicate this is a 301(k) sample and alert the reader to the fact that you are documenting adulteration

after shipment in interstate commerce. Use the Flag Remarks field to state the product or ingredient 

which has moved in interstate commerce and you have documented.

FACTS Page 2

Collection Method: Describe how you collected the sample and which subs are the 702(b) portion. Relate the 

number and size of the sampled units and subsamples to show how each was taken, e.g., "Two cans of product

randomly collected from each of 12 previously unopened cases selected at random." Note any special sampling 

techniques used, e.g.: "Subs collected using aseptic technique and placed in sterile glass jars or whirl-packs" or 

"Subs 1-10 consist of approx. 1# of product. Subsamples 1-10 collected from bulk storage Bin #1 composited in 

unused, brown, paper bag." Completely describe the collection method of each sub of selective samples with 

multiple subsamples, including your observations of the conditions, e.g.: “Two live insects collected from seam 

of bag #2. Live insects were observed exiting bag and two were collected upon exit.” You will normally need to 

use a continuation sheet to describe collection of all subsamples and your description of the lot “bag-by-bag” 

examination. See IOM 4.7.2.1 regarding sub identification.

Describe exactly how you collected the sample. Describe selective sampling technique if used. For 

example, “Two Live insects collected from seam of bag #2 and two live insects collected from seam of 

bag #12 (see diagram of lot sampled). Insects were seen entering and exiting bags. Insects were 

collected upon exit.” In a rodent or insect infested warehouse, you will most likely need to use the C/R 

Continuation to fully describe the subs you collect and their relationship to the depth of the adulteration

of product and infestation of the warehouse.

State: Select the State where the sample was collected. This field is optional for many samples. Always use it 

for pesticide samples.

Optional field, use for Pesticide Samples. Use the LOV (List of Values) button to select the state.
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County: Select the County where the sample was collected (or grown if appropriate, i.e., a pesticide sample of 

an agricultural product.) This field is not needed for many samples. Use for pesticide samples to aid in later 

communication with State officials in the event of a violative result. 

This field should be used to identify where the agricultural commodity was grown. In order to identify 

the county where the product was grown, you will either need to be collecting the sample from the 

grower or have documentation demonstrating shipment from the grower to the dealer. If the product is 

in a container bearing a label, do not simply assume any identified location is the actual location where 

the product was grown. It is common practice to reuse shipping crates in the produce industry.

Country of Origin: Select the Country of Origin, if known. This is a field of particular need when the sample is a 

Domestic Import Sample. 

Products sampled that had been imported into the United States and released to commerce by US 

Customs and Border Protection are Domestic Import samples. Obtain documentation of their entry 

(invoices, bills of lading, Customs Form 3461, etc.) where necessary to support a case involving the 

Importer of Record. Remember that these samples will be identified with a prefix to the sample number 

of DI.

Estimated Value: Enter the estimated wholesale value of the lot remaining after sampling. Obtain this 

information from invoice or other records. (This is not the value to be used for seizure bond purposes; however, 

it may be used by the divison to evaluate whether seizure is an appropriate action.) Estimate value if you have 

no documentary reference. For DOC samples (see IOM Exhibits 4-1 and 4-2), indicate the estimated value of the 

lot. If the DOC sample is collected to document a lot that has already been shipped, estimate the value, or 

obtain a figure from your documentation, which represents what was shipped. Many times, a DOC sample is 

collected merely to establish interstate commerce, in those situations, the value of the goods that traveled, or 

will travel, in interstate commerce is what is needed. 

5.10.8.9 Estimated Value: It may be difficult to estimate the value of a bioequivalence sample. If the firm is not 

able to provide you with the value of the lot remaining after sampling, use the estimated cost of the innovator if 

possible. If you cannot estimate, leave blank and note in the Collection Remarks, “Estimated Value is unknown.”

For pesticide samples, try to obtain the size of the field from which the produce was harvested. Have the 

dealer/grower provide you with the estimated yield per acre and determine the estimated value based 

on the wholesale value of the expected yield minus your sample. Note: For DOC 301(k) samples where 

no product is remaining the value will be $0. For bioequivalence samples, review the documentation of 

the shipment to the site to determine if values are included.

Sample Cost: Enter the cost of the sample. If no charge, enter 0. If, as a last resort, you use your personal credit 

card to pay for the sample, enter the amount paid in this field and select "Credit. Card" in the Payment Method 

field. If you are unable to determine the cost of the sample and the firm states they will bill you later, enter the 

estimated cost in this field and state that it is an estimate in the Collection Remarks field. 
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Note that the “Credit Card” option is for your personal credit card, not the Government credit card. You 

are to obtain a cash advance from an ATM or bank and use cash to pay for samples. If the firm will bill 

the agency for samples, obtain the invoice to submit with your C/R if at all possible.

Payment Method: Select one of the following from the from the list of values: "Billed"; "Borrowed"; "Cash"; 

"Credit Card"; "No Charge"; "Voucher". The “Credit Card” option means you used your personal credit card as a 

last resort.

Use the LOV button to access the drop down menu. Again, note that credit card is for your personal 

credit card, not the Government-issued credit card.

Receipt Issued: Select "FDA472", "FDA484", or "None" from the list of values. 

Use the LOV button to select which type of receipt you issued. You will only use an FDA 472 if you collect

a sample from a carrier, such as an in-transit sample from a truck.

Carrier name: Enter name of the transportation company who transported the goods in interstate commerce if 

known at the time of preparation of the CR. You may need to obtain this later to fully document interstate 

commerce. In the case of a 301(k) sample, this is the transportation company who moved the component you 

are documenting across state lines. For a 301(a) sample documenting the shipment of a violative product in 

interstate commerce, enter the name of the carrier utilized by the manufacturer or distributor to carry the 

goods across state lines. 

Note that this is a transportation company, not to be confused with a Shipper. A Shipper is an 

Establishment Type and is the entity responsible for causing the interstate movement of the product. 

Date Shipped: Enter date in the format, mm/dd/yyyy. This is the date of interstate shipment. Obtain it from the 

documentation you collected to document interstate movement of the product. Identify the document you 

used to determine this date in the “Documents Obtained” section.

Enter the date that the product was shipped in interstate commerce. This date should be obtained from 

a shipping record such as a bill or lading, waybill, freight bill, etc.

Consumer Complaint Number: If the sample relates to a consumer complaint, enter the complaint number. 

This will allow your CR to be linked to the complaint and viewed by the Consumer Complaint Coordinator and 

other Division and Center personnel.

Recall Number: If the sample was collected as part of a recall investigation where the recall number is already 

known, enter the recall number. 

If you conduct an inspection/investigation and collect a sample as follow-up to a recall, enter that recall 

number here. Although any routine sample collection may lead to a recall, at the time of sampling you 

would not know the recall number.
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How Prepared: Explain how the sample was prepared prior to submission to the laboratory; how you identified 

some or all the units; and how you wrapped and sealed the sample. Note any special preparation methods such 

as fumigation, frozen, kept under refrigeration, etc., and the form in which the sample was delivered to the 

laboratory, e.g., in paper bags, original carton, etc. If coolants or dry ice were used, indicate so here. It is 

important to be specific as to how you protected the integrity of the sample and the chain of custody, e.g., 

“Subs identified as noted (describe how 702(b) portion was prepared/handled – see IOM 4.7.2.1), placed in 

unused, brown, paper bag; bag taped shut and FDA seal completed (as noted) and applied, bag ID’d as noted in 

pen/ink. FDA 525 attached to sealed bag, placed in brown, cardboard box and prepared for shipment, then 

delivered to district security guard desk for UPS pickup”.

Include here the identification of sub samples (referencing the block ‘Collector’s ID on Package) and 

exactly how you packed the sample. Did you wrap in bubble wrap? Did you tape lids down? Did you use 

Styrofoam peanuts or cooling materials? Include everything you did to the sample from the point you 

collected it and prepared it for sample submission/shipment. Also, be sure to include that the sample 

was officially sealed and reference the block ‘Collector’s ID on Seal.’ If the sample was not prepared, 

sealed, and shipped the same day as collected, use ‘Collection Remarks’ to describe your efforts to 

maintain the integrity of the sample and chain of custody.

Collector's ID on Package/Document: As the Sample Collector, quote your identification placed on the 

packages, labels, etc., e.g., "55563 12/5/05 SAR". See IOM 4.6.2.11. When multiple units are collected, all or at 

least a portion should be labeled as subsamples. Subsample numbers need to be included on the C/R and in the 

EIR. You may include the sub numbers used in this block outside of the quotes, e.g., “55563 12/5/05 SAR” subs 

1-30.

Quote exactly as you identified the sample. What does the “at least a portion” reference mean? When 

collecting samples with a large number of identical subs, such as 30 packages of shrimp that are 

packaged exactly the same from the same lot, it may be permissible to identify the first six subsamples

with the full sample identification and the remaining subs to be identified with the sub number only. 

Check with your supervisor for the division policy. Note that every subsample collected will bear the sub 

number as this correlates to the shipping container you collected it from. As you are collecting your 

samples, you identify the carton, case, shipping container with FDA, sample number, sub number, date, 

and your initials. This allows identification that the container was opened and sampled by FDA as well as 

which carton which sub was collected from. Sometimes it is necessary to return and collect an additional 

sample from the same lot and sometimes from the same carton as a particular sub was collected from.

Collector's ID on Seal: Quote your identification used on the Official Seal applied to the sample, e.g., "55563 

12/5/05 Sylvia A. Rogers". See IOM 4.6.2.11 and Exhibit 4-17. If you use the FDA metal seal, enter the words 

"Metal Seal" followed by the seal identification and number, e.g., "U.S. Food & Drug 233", entering the actual 

number of the seal used. Samples need to be kept under lock or in your possession, until sealed. The Collection

Remarks field needs to describe any discrepancy between the date sealed and the date collected. Normally, the 

sample should be sealed on the same day as collected. 

If you are unable to seal the sample on the same day of collection, describe what steps you took to 

maintain the sample integrity and chain of custody. For example, “Sample held under lock and key in 

sample preparation room until sealed on 12/5/05.”
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Sample Delivered To: Enter to whom you delivered the physical sample. If delivered to your own sample 

custodian under seal, show delivery to servicing laboratory or sample custodian. If delivered to an analyst, 

report e.g., "In person to Analyst Richard R. Doe." If you shipped the sample, enter the name of the carrier to 

whom the sampled was delivered. Enter the Government Bill of Lading Number, if used. If the sample is shipped 

by air, enter the air waybill number. If shipment is by parcel post, give the location of the post office, e.g., "P.P., 

Austin, TX." For a DOC sample, leave this field blank. If the sample is being sent to a non-FACTS laboratory, enter 

the laboratory here. 

If delivered to the office secure lobby for pick up by carrier state so such as, “Delivered to BLT-DO secure 

lobby for FedEx pick up AWB #_________.”

Sample Delivered Date: Enter the date on which the sample was delivered to the laboratory or for shipment. 

For DOC samples, you must leave this field blank. If you make an entry, you must enter a laboratory. 

CR & Records Sent to: Enter the division which is most likely to initiate any regulatory action. This field requires 

some thought on the part of the collector and communication with the supervisor. For a 301(k) sample, where 

the dealer is responsible, this is the division where the sample was collected. Do not assume the address on the 

label is the location where follow-up to a violative sample will be initiated. Do not send the records to another 

division unless you know it is the division of the actual responsible firm. Per Staff Manual Guide f 2460.2, Field 

Office Filing System (or f:3291.2 as listed on the FDA internet site), field survey samples will be filed by the 

collecting division.

When a Non-FACTs affiliation is selected, provide the reason in the remarks section.

5.10.8.10 CR & Records Sent To FACTS Org: For domestic CRs, select your division from the list of values and 

send the hard copy CR and all associated documents to the director of investigations for your division when 

complete. For samples collected on foreign inspections, select the appropriate center/division (e.g., CDER-CP for 

bioequivalence samples) from the dropdown menu and send the hard copy CR and all associated documents to 

the center/division office contact specified in the assignment memorandum.

Think about the violation you are documenting and who is responsible. Think about the action of choice. 

The office that would lead or take the action needs to have the original records associated with a sample 

collection to prepare recommendations and court documents. If you a sampling a large lot suspected of 

microbiological adulteration, the action of choice would be seizure of the lot. If you are sampling a lot in 

transit, the destination division would be appropriate if seizure is the action considered. If the sample is 

to support an injunction of the manufacturer, then the home division of the manufacturer would be 

appropriate after documenting the responsibility, I/S and actual location of the manufacturing site. If 

there were a violation associated with a bioequivalence sample, the center would be the office to take 

the action. If the records will go to a non-FACTS organization, such as the State, enter that information 

in the appropriate field.

Storage Requirements: Select from the following list of values: Ambient; Frozen; Refrigerated. 

Storage requirements are those that the sample was stored at when collected or required based on 

situation. State how the sample should be stored once received by the sample custodian. Remember to 
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complete the FDA 525 with the same information and to include any special preparations in the ‘How 

Prepared’ block.

Dairy Permit Number: Enter if applicable. If you are collecting samples from a dairy, obtain this number from 

the firm.

704(d) Sample: 

Check the 704(d) box if all answers to the following questions are “yes,”:

1. Was the sample collected a food?

2. Was the sample collected during an inspection?

3. Was the sample collected from an establishment where food is manufactured, processed, or packed?

4. Was the sample collected to ascertain whether such food consists in whole or in part of any filthy, putrid, or 

decomposed substance, or is otherwise unfit for food?

Note: Guidance on 704(d) is provided in FMD-147 including examples of what constitutes “unfit for food”. 

Include in the Collection Remarks the name, title, email address (if available) and telephone/fax number of the 

most responsible person at the firm. See also IOM 4.6.2.9.

National Drug Code: Enter if applicable 

For samples of drug products.

CRx/DEA Schedule: Choose the appropriate schedule from the list of values, if applicable. 

For samples of controlled substances.

702(b) Portion Collected: Check this box if the sample you collected contains a 702(b) Portion of any food, drug 

or cosmetic to be held by FDA for release to the owner or person named on the label for their own analysis. This 

includes samples where 1) the sample schedule already accounts for the 702(b), 2) you collected in duplicate 

and separated the duplicate out and 3) you collected in duplicate and did not separate the duplicate out. If you 

did not separate the 702(b) portion, note this in the remarks so the laboratory can separate the 702(b) portion. 

If no 702(b) portion was collected, do not check this box, and provide reason for non-collection in the Collection 

Remarks section (4.6.2.9).

When the sample size includes the 702(b) portion, you will check this box although you did not collect a 

separate portion to be reserved, it is intended that the laboratory will portion out the reserve and 

maintain, if possible.

Collection PACs Section
EXHBIT 4-25 INVESTIGATIONS OPERATIONS MANUAL 2023

4-180

PAC Code: Enter the Program Assignment Code (PAC), which is most correct, from the list of values. If the PAC 

on your assignment is not listed, discuss with your supervisor or FACTS Lead User. 

Enter all PACs you collected subs for analysis. When collecting samples, you should try to be as creative 

as possible. If collecting grain for pesticide analysis and that grain can go either to human food or 

animal food production, select PACs for both human pesticides and animal feed contaminants. Also, try 

to think of sampling for multiple PACs when possible. Grains is a good example here also. If collecting 

grains for pesticides, consider collecting a portion for Mycotoxin analysis as well. You will need to verify 

the labs conducting the analyses to ensure you ship your samples correctly.

FACTS Org Section

Sample Sent To: Collecting divisions are instructed to submit samples utilizing the Lab Servicing Table (LST) 

Dashboard located on the intranet on the ORS Sample Distribution site. See IOM 4.6.3. If you are splitting the 

sample among multiple laboratories for various analyses, enter each laboratory separately. Generally, in that 

case you will have more than one PAC code. If, because of your assignment, you are aware the sample should be 

forwarded to a second laboratory after the first analysis is complete, include that information in the Collection

Remarks field. However, you should only enter a laboratory in this field if you are sending the sample there, not 

if the laboratory will be expected to forward it. For a DOC sample, leave this blank. If the sample is to be sent to 

a non-FACTS lab, leave this field blank, enter the lab in the Sample Delivered To field, print a copy of the 

collection record and enclose it in the FDA 525 attached to the sample.
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 4-25 

4-181

INDEX

3

301(a).........4-3, 4-12, 4-25, 4-30, 4-60, 4-78, 4-196, 4-201

301(k).. 4-1, 4-3, 4-7, 4-12, 4-17, 4-18, 4-58, 4-61, 4-62, 4-

69, 4-78, 4-81, 4-83, 4-84, 4-87, 4-89, 4-118, 4-196, 4-

197, 4-199, 4-200, 4-201, 4-203

7

702(b) 4-2, 4-6, 4-10, 4-14, 4-24, 4-32, 4-33, 4-37, 4-45, 4-

54, 4-55, 4-79, 4-80, 4-87, 4-91, 4-93, 4-99, 4-139, 4-

142, 4-143, 4-144, 146, 4-154, 4-159, 165, 4-167, 4-

169, 4-174, 4-177, 4-178, 4-179, 4-180, 4-181, 4-195, 

4-199, 4-202, 4-204, 4-205

A

Actions 4-9, 4-10, 4-12, 4-13, 4-14, 4-15, 4-16, 4-18, 4-22, 

4-27, 4-29, 4-30, 4-31, 4-32, 4-45, 4-48, 4-49, 4-56, 4-

59, 4-60, 4-61, 4-62, 4-67, 4-72, 4-75, 4-77, 4-80, 4-81, 

4-82, 4-84, 4-88, 4-92, 4-96, 146, 4-152, 4-156, 4-173, 

4-174, 4-178, 4-194, 4-200, 4-203, 4-204

Administrative Actions ...................................... 4-13, 4-16

Adulterated...4-3, 4-11, 4-12, 4-15, 4-17, 4-18, 4-24, 4-25, 

4-30, 4-32, 4-44, 4-45, 4-46, 4-59, 4-60, 4-61, 4-62, 4-

69, 4-70, 4-72, 4-84, 4-173, 4-174, 4-175, 4-196, 4-199, 

4-204

Advisory Actions................................................ 4-13, 4-16

Affidavit ... 4-4, 4-10, 4-16, 4-17, 4-30, 4-58, 4-60, 4-62, 4-

63, 4-65, 4-66, 4-67, 4-68, 4-69, 4-70, 4-71, 4-73

Alcohol....................................4-41, 4-42, 4-46, 4-51, 4-96

Allergens....................................................................4-186

Ammonia ........................................................... 4-95, 4-97

Aseptic 4-2, 4-40, 4-41, 4-42, 4-43, 4-44, 4-52, 4-53, 4-79, 

4-139, 4-152, 166, 4-199

ATM ........................................................ 4-29, 4-37, 4-201

ATM cash advances...............................................4-201

Authority..........................4-1, 4-11, 4-24, 4-27, 4-30, 4-63

B

Basis 4-6, 4-13, 4-16, 4-21, 4-22, 4-23, 4-36, 4-54, 4-56, 4-

75, 4-85, 4-89, 146, 4-156, 4-193

Bill of Lading .4-3, 4-17, 4-22, 4-63, 4-64, 4-66, 4-82, 4-97, 

4-198, 4-203

BIMO.....................................................................4-4, 4-73

Bioresearch Monitoring.......... 4-4, 4-66, 4-73, 4-76, 4-101

Brand .............................4-4, 4-5, 4-74, 4-78, 4-120, 4-197

BSE..................................................... 4-2, 4-11, 4-37, 4-38

C

Carrier....4-1, 4-3, 4-5, 4-7, 4-12, 4-13, 4-16, 4-17, 4-25, 4-

28, 4-34, 4-39, 4-63, 4-64, 4-65, 4-78, 4-83, 4-89, 4-98, 

4-102, 4-104, 4-156, 4-195, 4-196, 4-201, 4-203

Cash ............................................... 4-28, 4-29, 4-37, 4-201

CDER ............................................................................4-28

CDRH..........................................................................4-189

CFSAN ..........................4-7, 4-8, 4-48, 4-133, 4-135, 4-186

Clothing .................................................... 4-37, 4-52, 4-95

Code.. 4-4, 4-6, 4-13, 4-19, 4-21, 4-31, 4-36, 4-54, 4-57, 4-

62, 4-65, 4-74, 4-75, 4-79, 4-85, 4-87, 4-88, 4-90, 4-93, 

4-137, 4-139, 4-141, 4-144, 4-164, 4-193, 4-197, 4-198, 

4-204, 4-205

Code of Federal Regulation .........................................4-13

Collection...4-1, 4-2, 4-3, 4-4, 4-5, 4-9, 4-10, 4-11, 4-12, 4-

13, 4-14, 4-15, 4-16, 4-17, 4-18, 4-19, 4-21, 4-22, 4-23, 

4-24, 4-25, 4-26, 4-27, 4-28, 4-30, 4-31, 4-32, 4-33, 4-

35, 4-36, 4-37, 4-38, 4-39, 4-40, 4-41, 4-42, 4-43, 4-44, 

4-45, 4-46, 4-47, 4-48, 4-49, 4-51, 4-52, 4-53, 4-54, 4-

55, 4-57, 4-58, 4-59, 4-60, 4-61, 4-62, 4-63, 4-65, 4-67, 

4-69, 4-70, 4-71, 4-72, 4-73, 4-74, 4-75, 4-76, 4-78, 4-

79, 4-81, 4-82, 4-83, 4-84, 4-85, 4-88, 4-89, 4-90, 4-91, 

4-92, 4-93, 4-94, 4-96, 4-99, 4-100, 4-101, 4-103, 4-

133, 4-135, 4-137, 4-140, 4-141, 4-142, 4-143, 4-144, 

146, 4-147, 4-148, 4-149, 4-150, 4-151, 4-152, 4-153, 

4-154, 4-156, 160, 161, 162, 4-163, 4-164, 165, 4-167, 

4-169, 4-171, 4-173, 4-174, 4-176, 4-177, 4-179, 4-180, 

4-181, 4-182, 4-190, 4-192, 4-193, 4-194, 4-195, 4-196, 

4-198, 4-199, 4-200, 4-201, 4-202, 4-203, 4-204, 4-205

Collection Report.4-12, 4-14, 4-15, 4-16, 4-22, 4-58, 4-59, 

4-62, 4-63, 4-65, 4-67, 4-73, 4-75, 4-141, 146, 4-148, 4-

151, 4-192, 4-194, 4-195, 4-196, 4-197, 4-201, 4-203

Complainant ................................................................4-84

Complaint ...4-3, 4-5, 4-21, 4-22, 4-35, 4-62, 4-74, 4-81, 4-

84, 4-196, 4-201

Conduct 4-47, 4-48, 4-49, 4-57, 4-58, 4-102, 4-141, 4-144, 

4-202
EXHBIT 4-25 INVESTIGATIONS OPERATIONS MANUAL 2023

4-182

Controls ....4-25, 4-41, 4-43, 4-44, 4-53, 4-54, 4-55, 4-139, 

166, 4-177, 4-180, 4-181

Conveyances............................................. 4-2, 4-35, 4-101

Cosmetics........................4-17, 4-163, 4-164, 4-186, 4-187

Cost4-15, 4-27, 4-28, 4-29, 4-33, 4-37, 4-63, 4-74, 4-89, 4-

102, 4-151, 4-167, 4-200

Counterfeit ........................................................ 4-13, 4-14

Criminal..........................4-3, 4-24, 4-62, 4-64, 4-89, 4-192

CVM ...........................................................................4-190

D

Dealer .. 4-1, 4-2, 4-3, 4-4, 4-5, 4-7, 4-12, 4-23, 4-24, 4-25, 

4-26, 4-29, 4-61, 4-68, 4-72, 4-83, 4-84, 4-89, 4-124, 4-

195, 4-196

Death ...........................................................................4-12

Denaturing...................................................................4-30

Destruction ..................................................................4-55

Detention......................................... 4-16, 4-30, 4-31, 4-86

Disease........................................................... 4-133, 4-135

Documents. 4-3, 4-5, 4-15, 4-16, 4-20, 4-22, 4-27, 4-28, 4-

34, 4-36, 4-43, 4-58, 4-59, 4-63, 4-65, 4-66, 4-70, 4-73, 

4-74, 4-75, 4-76, 4-78, 4-81, 4-82, 4-92, 4-94, 4-156, 

161, 4-195, 4-198, 4-201, 4-203, 4-204

Domestic Import..4-1, 4-4, 4-19, 4-20, 4-22, 4-76, 4-81, 4-

90, 4-193, 4-194, 4-200

DOT.....................................4-64, 4-95, 4-96, 4-102, 4-104

Drug4-1, 4-5, 4-6, 4-11, 4-23, 4-24, 4-25, 4-28, 4-35, 4-54, 

4-63, 4-64, 4-66, 4-80, 4-81, 4-86, 4-87, 4-101, 4-103, 

4-171, 4-186, 4-187, 4-188, 4-203, 4-204

Dry Ice4-43, 4-87, 4-97, 4-98, 4-104, 4-149, 4-154, 162, 4-

202

Dust..........4-11, 4-37, 4-38, 4-41, 4-42, 4-53, 4-135, 4-140

E

Embargo............................................................. 4-30, 4-86

Emergency ............................4-15, 4-35, 4-40, 4-51, 4-102

eNSpect........................................................................4-73

EPA...............................................................................4-47

Evidence.. 4-3, 4-8, 4-9, 4-10, 4-13, 4-14, 4-15, 4-16, 4-20, 

4-21, 4-22, 4-44, 4-46, 4-59, 4-60, 4-61, 4-62, 4-64, 4-

65, 4-72, 4-85, 4-88, 4-89, 4-100, 4-141, 146, 4-149, 4-

153, 4-154, 4-156, 4-163, 4-169, 4-171, 4-173, 4-174, 

4-176, 4-177, 4-179, 4-180, 4-181, 4-193, 4-197

Exhibits 4-5, 4-6, 4-8, 4-15, 4-16, 4-17, 4-22, 4-25, 4-26, 4-

32, 4-36, 4-44, 4-45, 4-46, 4-48, 4-57, 4-65, 4-66, 4-68, 

4-69, 4-75, 4-76, 4-77, 4-78, 4-79, 4-80, 4-82, 4-84, 4-

85, 4-87, 4-88, 4-89, 4-90, 4-94, 4-96, 4-98, 4-100, 4-

101, 4-102, 4-103, 4-104, 4-154, 4-173, 4-175, 4-176, 

4-177, 4-179, 4-180, 4-192, 4-193, 4-194, 4-195, 4-197, 

4-198, 4-199, 4-200, 4-203

Expenses......................................................................4-28

Explosive......................................................................4-41

Exposure ......................4-37, 4-38, 4-40, 4-47, 4-95, 4-104

F

FACTS.. 4-4, 4-7, 4-8, 4-10, 4-11, 4-33, 4-54, 4-59, 4-74, 4-

75, 4-76, 4-77, 4-78, 4-80, 4-81, 4-82, 4-83, 4-84, 4-85, 

4-88, 4-89, 4-90, 4-92, 4-94, 4-101, 4-102, 4-103, 4-

106, 4-110, 4-127, 4-128, 4-142, 161, 4-192, 4-194, 4-

195, 4-196, 4-197, 4-199, 4-203, 4-204, 4-205

Farm..................4-11, 4-12, 4-36, 4-37, 4-54, 4-137, 4-140

FDA 464a ....................................... 4-15, 4-77, 4-79, 4-195

FDA 472 ......................................... 4-7, 4-25, 4-112, 4-201

FDA 482 .....4-12, 4-23, 4-24, 4-25, 4-26, 4-38, 4-91, 4-204

FDA 484 .........4-2, 4-7, 4-15, 4-25, 4-26, 4-39, 4-93, 4-113

FDASIA .........................................................................4-24

Feed........4-2, 4-37, 4-38, 146, 4-147, 4-160, 4-169, 4-205

Field Examination .....4-3, 4-32, 4-45, 4-141, 4-144, 4-153, 

161

Filth 4-3, 4-5, 4-8, 4-22, 4-33, 4-41, 4-44, 4-46, 4-57, 4-58, 

4-61, 4-77, 4-84, 4-85, 4-88, 4-142, 161, 4-168, 4-173, 

4-194, 4-196, 4-197, 4-204

Flag ........................ 4-5, 4-78, 4-84, 4-85, 4-86, 146, 4-199

FMS.....................................................................4-75, 4-82

Foreign.4-2, 4-19, 4-24, 4-38, 4-39, 4-47, 4-57, 4-74, 4-76, 

4-90, 4-193, 4-203

Freedom of Information.....................................4-56, 4-68

Freedom of Information Act...............................4-56, 4-68

Frozen4-6, 4-7, 4-41, 4-43, 4-46, 4-47, 4-52, 4-53, 4-60, 4-

91, 4-94, 4-96, 4-97, 4-98, 4-99, 4-103, 4-104, 4-120, 4-

134, 4-138, 4-139, 4-147, 4-148, 4-149, 4-154, 4-179, 

4-202, 4-204

Fumigation.....4-6, 4-84, 4-87, 4-95, 4-96, 4-149, 4-170, 4-

178, 4-202

G

Gases ...........................................................................4-35

Gloves........4-32, 4-38, 4-41, 4-44, 4-50, 4-51, 4-54, 4-176

Government Travel Charge Card.................................4-37

Grain ..................4-139, 4-153, 4-154, 4-176, 4-182, 4-205

H

Hazard ......................................... 4-11, 4-38, 4-101, 4-137

Hold .4-23, 4-29, 4-30, 4-100, 4-154, 161, 4-176, 4-179, 4-

180, 4-196

I

IATA .......................................................... 4-95, 4-96, 4-98

IH 4-11, 4-104

Import4-1, 4-9, 4-10, 4-11, 4-13, 4-18, 4-19, 4-20, 4-27, 4-

31, 4-33, 4-37, 4-38, 4-39, 4-40, 4-44, 4-63, 4-73, 4-77, 

4-86, 4-90, 4-137, 4-139, 4-141, 4-142, 146, 4-156, 

161, 4-173, 4-174, 4-193, 4-200

Informant.....................................................................4-68

Injunction..............................................................4-3, 4-62

Injury........................................................... 4-3, 4-22, 4-62
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 4-25 

4-183

Interaction ......................................................... 4-23, 4-36

Internet............................................................ 4-15, 4-203

Interstate . 4-3, 4-12, 4-13, 4-14, 4-15, 4-16, 4-17, 4-18, 4-

21, 4-22, 4-26, 4-34, 4-37, 4-58, 4-59, 4-60, 4-61, 4-62, 

4-63, 4-64, 4-65, 4-69, 4-70, 4-72, 4-77, 4-78, 4-81, 4-

82, 4-83, 4-84, 4-178, 4-179, 4-181, 4-193, 4-194, 4-

196, 4-198, 4-199, 4-200, 4-201

Interstate Commerce..4-3, 4-12, 4-13, 4-14, 4-15, 4-16, 4-

17, 4-18, 4-22, 4-37, 4-58, 4-59, 4-60, 4-61, 4-62, 4-63, 

4-64, 4-65, 4-69, 4-70, 4-72, 4-77, 4-78, 4-84, 4-193, 4-

194, 4-196, 4-199, 4-200, 4-201

In-transit.............................................................. 4-1, 4-16

J

Judicial Actions .................................................. 4-13, 4-59

Jurisdiction..4-10, 4-13, 4-14, 4-16, 4-22, 4-23, 4-34, 4-58, 

4-59, 4-62, 4-63, 4-64, 4-66, 4-70, 4-77

L

Laboratory Servicing Table ..4-6, 4-78, 4-90, 4-91, 4-92, 4-

103, 4-205

Limiting ................................................................ 4-1, 4-24

Lot 4-1, 4-2, 4-4, 4-6, 4-10, 4-12, 4-13, 4-14, 4-16, 4-17, 4-

18, 4-20, 4-21, 4-22, 4-23, 4-24, 4-25, 4-26, 4-27, 4-29, 

4-30, 4-31, 4-33, 4-40, 4-43, 4-44, 4-45, 4-46, 4-53, 4-

54, 4-55, 4-57, 4-59, 4-60, 4-62, 4-63, 4-64, 4-66, 4-68, 

4-69, 4-70, 4-71, 4-72, 4-74, 4-76, 4-77, 4-78, 4-79, 4-

82, 4-83, 4-86, 4-87, 4-93, 4-133, 4-135, 4-137, 4-139, 

4-141, 4-142, 4-143, 4-144, 4-145, 146, 4-149, 4-150, 

4-152, 4-156, 4-157, 157, 4-159, 161, 162, 4-163, 4-

164, 165, 4-167, 4-169, 4-170, 4-173, 4-174, 4-175, 4-

176, 4-177, 4-178, 4-179, 4-180, 4-181, 4-182, 4-187, 

4-192, 4-193, 4-194, 4-196, 4-198, 4-199, 4-200, 4-202, 

4-204

M

Mail4-1, 4-4, 4-19, 4-21, 4-39, 4-65, 4-77, 4-102, 4-103, 4-

195, 4-204

Mandatory Recall.........................................................4-16

Manufacturer..4-1, 4-5, 4-12, 4-17, 4-18, 4-23, 4-26, 4-28, 

4-33, 4-39, 4-40, 4-41, 4-46, 4-50, 4-60, 4-61, 4-69, 4-

71, 4-72, 4-78, 4-83, 4-88, 4-90, 4-91, 4-100, 4-105, 4-

142, 4-144, 4-177, 4-181, 4-193, 4-196, 4-197, 4-198, 

4-201, 4-204

Marks................................................................... 4-6, 4-93

Medical 4-2, 4-14, 4-18, 4-29, 4-32, 4-36, 4-49, 4-50, 4-55, 

4-56, 4-78, 4-98, 4-174, 4-189, 4-197

Microorganisms......................4-3, 4-47, 4-48, 4-55, 4-144

Misbranded ..4-3, 4-11, 4-12, 4-15, 4-16, 4-17, 4-18, 4-44, 

4-60, 4-61, 4-69, 4-70, 4-71, 4-72, 162, 4-169

Mold ........................................ 4-8, 4-46, 4-47, 161, 4-181

N

Narcotic ...................................................... 4-1, 4-25, 4-26

Non-regulatory ............................................................4-23

O

Objections.............................................................4-1, 4-24

ORA Safety Office ...............................................4-35, 4-37

Organization .....................................................4-23, 4-204

Organoleptic .........................................................4-3, 4-57

Origin 4-5, 4-6, 4-19, 4-58, 4-61, 4-64, 4-65, 4-69, 4-75, 4-

76, 4-81, 4-90, 146, 4-147, 4-148, 4-156, 4-174, 4-193, 

4-200

Other Government Agencies................................4-2, 4-27

Outbreak............................................... 4-47, 4-135, 4-140

P

Payment.4-2, 4-6, 4-25, 4-27, 4-28, 4-29, 4-36, 4-87, 4-89, 

4-200, 4-201

Perishable.................................... 4-19, 4-30, 4-102, 4-103

Personal Protective Equipment..........................4-11, 4-38

Personal Safety........................................... 4-1, 4-11, 4-97

Pesticide ....4-5, 4-81, 4-82, 4-85, 4-86, 4-95, 4-96, 146, 4-

153, 4-194, 4-199, 4-200, 4-205

Photographs.4-6, 4-16, 4-20, 4-22, 4-35, 4-44, 4-45, 4-46, 

4-49, 4-58, 4-71, 4-72, 4-76, 4-82, 4-90, 4-94, 4-140, 4-

142, 4-173, 4-175, 4-194, 4-198

Post-seizure ................4-1, 4-2, 4-4, 4-18, 4-20, 4-27, 4-77

Poultry ........................................................... 4-148, 4-163

Powders............................................................4-53, 4-148

Prescription .............................................. 4-25, 4-26, 4-63

Prior Notice..................................................................4-39

Produce4-5, 4-33, 4-37, 4-86, 4-135, 4-140, 4-141, 146, 4-

147, 4-151, 4-152, 4-182, 4-200

Product..4-1, 4-3, 4-4, 4-6, 4-10, 4-12, 4-13, 4-14, 4-15, 4-

16, 4-17, 4-18, 4-19, 4-20, 4-21, 4-22, 4-23, 4-27, 4-28, 

4-30, 4-31, 4-33, 4-34, 4-35, 4-37, 4-39, 4-40, 4-41, 4-

42, 4-44, 4-45, 4-46, 4-47, 4-48, 4-49, 4-50, 4-52, 4-54, 

4-55, 4-56, 4-57, 4-58, 4-59, 4-60, 4-61, 4-62, 4-63, 4-

69, 4-70, 4-71, 4-73, 4-74, 4-75, 4-76, 4-77, 4-78, 4-79, 

4-80, 4-81, 4-82, 4-83, 4-84, 4-85, 4-87, 4-88, 4-89, 4-

91, 4-93, 4-94, 4-95, 4-96, 4-98, 4-99, 4-103, 4-104, 4-

133, 4-135, 4-137, 4-139, 4-141, 4-142, 4-144, 4-148, 

4-152, 4-153, 4-159, 4-164, 165, 4-169, 4-171, 4-173, 

4-174, 4-175, 4-176, 4-177, 4-178, 4-179, 4-180, 4-181, 

4-190, 4-193, 4-194, 4-195, 4-196, 4-197, 4-198, 4-199, 

4-200, 4-201

Prosecution........................................ 4-3, 4-14, 4-62, 4-64

R

Radiation .............................................. 4-11, 4-101, 4-189

Random ..4-3, 4-45, 4-46, 4-57, 4-79, 4-139, 4-150, 4-156, 

161, 4-169, 4-171, 4-193, 4-199
EXHBIT 4-25 INVESTIGATIONS OPERATIONS MANUAL 2023

4-184

Recall ........................................................ 4-6, 4-88, 4-202

Receipt 4-1, 4-3, 4-6, 4-15, 4-17, 4-18, 4-25, 4-26, 4-29, 4-

36, 4-39, 4-60, 4-61, 4-64, 4-65, 4-69, 4-70, 4-72, 4-88, 

4-93, 4-152, 4-196, 4-201

Receipts .......................................................................4-26

Recondition................................ 4-30, 4-176, 4-179, 4-180

Reconditioning.. 4-1, 4-2, 4-20, 4-27, 4-30, 4-86, 161, 162, 

4-176, 4-179, 4-180

Records... 4-2, 4-3, 4-4, 4-5, 4-6, 4-13, 4-14, 4-15, 4-16, 4-

18, 4-19, 4-20, 4-22, 4-25, 4-26, 4-34, 4-58, 4-59, 4-61, 

4-62, 4-63, 4-64, 4-65, 4-66, 4-68, 4-69, 4-70, 4-73, 4-

74, 4-76, 4-79, 4-81, 4-82, 4-87, 4-90, 4-92, 4-94, 4-

101, 4-103, 4-186, 4-192, 4-194, 4-195, 4-198, 4-200, 

4-203, 4-204

Refrigerated..4-7, 4-31, 4-40, 4-60, 4-91, 4-94, 4-98, 4-99, 

4-133, 4-134, 4-149, 4-204

Refusal ..... 4-1, 4-3, 4-4, 4-11, 4-24, 4-25, 4-64, 4-67, 4-68

Regulatory Meeting .....................................................4-16

Regulatory Notes..4-10, 4-14, 4-30, 4-31, 4-35, 4-45, 4-99

Relabeling ....................................................................4-83

Report. 4-3, 4-4, 4-9, 4-10, 4-11, 4-16, 4-17, 4-18, 4-19, 4-

21, 4-24, 4-26, 4-28, 4-34, 4-45, 4-56, 4-57, 4-58, 4-59, 

4-64, 4-71, 4-73, 4-75, 4-76, 4-80, 4-89, 4-94, 4-141, 4-

142, 4-153, 4-154, 160, 161, 162, 4-175, 4-195, 4-196, 

4-203

Reporting ..... 4-3, 4-4, 4-9, 4-10, 4-24, 4-56, 4-75, 4-76, 4-

141, 4-154, 161

Respiratory ..................................................................4-38

Responsibility...4-30, 4-40, 4-56, 4-59, 4-60, 4-62, 4-64, 4-

66, 4-72, 4-92, 4-173, 4-204

Rodent ...................4-8, 4-153, 4-174, 4-175, 4-176, 4-177

Routing ........................................................................4-25

S

Safety 4-6, 4-9, 4-11, 4-24, 4-35, 4-37, 4-38, 4-41, 4-43, 4-

47, 4-48, 4-55, 4-64, 4-95, 4-101, 4-104, 4-133, 4-135, 

4-136, 4-137, 4-163, 4-176, 4-186, 4-187, 4-188

Sample ... 4-1, 4-2, 4-3, 4-4, 4-5, 4-6, 4-7, 4-8, 4-9, 4-10, 4-

11, 4-12, 4-13, 4-14, 4-15, 4-16, 4-17, 4-18, 4-19, 4-20, 

4-21, 4-22, 4-23, 4-24, 4-25, 4-26, 4-27, 4-28, 4-29, 4-

30, 4-31, 4-32, 4-33, 4-34, 4-35, 4-36, 4-37, 4-38, 4-39, 

4-40, 4-41, 4-42, 4-43, 4-44, 4-45, 4-46, 4-47, 4-48, 4-

49, 4-50, 4-51, 4-52, 4-53, 4-54, 4-55, 4-56, 4-57, 4-58, 

4-59, 4-62, 4-63, 4-65, 4-66, 4-67, 4-69, 4-70, 4-71, 4-

73, 4-74, 4-75, 4-76, 4-77, 4-78, 4-79, 4-80, 4-81, 4-82, 

4-83, 4-84, 4-85, 4-86, 4-87, 4-88, 4-89, 4-90, 4-91, 4-

92, 4-93, 4-94, 4-95, 4-96, 4-97, 4-98, 4-99, 4-100, 4-

101, 4-102, 4-103, 4-104, 4-105, 4-133, 4-135, 4-139, 

4-140, 4-141, 4-142, 4-143, 4-144, 146, 4-147, 4-148, 

4-149, 4-150, 4-151, 4-152, 4-153, 4-154, 4-155, 4-156, 

4-157, 4-159, 160, 161, 162, 4-163, 4-164, 165, 166, 4-

167, 4-168, 4-169, 4-170, 4-171, 4-173, 4-174, 4-177, 

4-178, 4-179, 4-181, 4-182, 4-186, 4-187, 4-188, 4-189, 

4-190, 4-192, 4-193, 4-194, 4-195, 4-196, 4-197, 4-198, 

4-199, 4-200, 4-201, 4-202, 4-203, 4-204, 4-205

Sample Types.............................................................4-186

Audit Sample............................. 4-20, 4-21, 4-86, 4-150

Documentary ..4-1, 4-4, 4-10, 4-13, 4-14, 4-15, 4-16, 4-

18, 4-20, 4-22, 4-62, 4-76, 4-78, 4-82, 4-87, 4-88, 4-

89, 4-90, 4-91, 4-94, 4-96, 4-99, 4-169, 4-192, 4-

195, 4-197, 4-198, 4-200, 4-203, 4-205

Environmental...4-3, 4-7, 4-8, 4-17, 4-22, 4-33, 4-40, 4-

41, 4-43, 4-44, 4-47, 4-48, 4-49, 4-50, 4-51, 4-52, 4-

53, 4-54, 4-56, 4-77, 4-80, 4-84, 4-88, 4-133, 4-135, 

4-136, 4-140, 4-173, 4-193, 4-196, 4-197

Factory .................. 4-3, 4-5, 4-22, 4-54, 4-63, 4-84, 160

Import Sample.........4-1, 4-13, 4-18, 4-73, 4-142, 4-193

Induced Sample................................................4-1, 4-21

Investigational Sample .4-1, 4-4, 4-17, 4-20, 4-22, 4-37, 

4-44, 4-54, 4-70, 4-77, 4-84, 4-89, 4-93, 4-140, 4-

141, 4-142, 4-151, 160, 165, 4-169, 4-178, 4-179, 4-

193, 4-194

Official Sample ............... 4-1, 4-13, 4-142, 4-151, 4-169

Online Sample ...................... 4-1, 4-21, 4-22, 4-25, 4-29

Physical............................... 4-1, 4-11, 4-15, 4-16, 4-169

Survey..........................4-1, 4-5, 4-23, 4-81, 4-86, 4-203

Undercover sample.................................................4-21

Valid Sample........................... 4-1, 4-9, 4-10, 4-13, 4-14

Sampling 4-1, 4-2, 4-3, 4-4, 4-5, 4-6, 4-7, 4-8, 4-9, 4-10, 4-

11, 4-12, 4-13, 4-14, 4-15, 4-16, 4-17, 4-18, 4-19, 4-20, 

4-21, 4-22, 4-23, 4-24, 4-25, 4-26, 4-27, 4-28, 4-29, 4-

30, 4-31, 4-32, 4-33, 4-34, 4-35, 4-36, 4-37, 4-38, 4-39, 

4-40, 4-41, 4-42, 4-43, 4-44, 4-45, 4-46, 4-47, 4-48, 4-

49, 4-50, 4-51, 4-52, 4-53, 4-54, 4-55, 4-56, 4-57, 4-58, 

4-59, 4-62, 4-63, 4-65, 4-66, 4-67, 4-68, 4-69, 4-70, 4-

71, 4-73, 4-74, 4-75, 4-76, 4-77, 4-78, 4-79, 4-80, 4-81, 

4-82, 4-83, 4-84, 4-85, 4-86, 4-87, 4-88, 4-89, 4-90, 4-

91, 4-92, 4-93, 4-94, 4-95, 4-96, 4-97, 4-98, 4-99, 4-

100, 4-101, 4-102, 4-103, 4-104, 4-118, 4-133, 4-135, 

4-136, 4-137, 4-138, 4-139, 4-140, 4-141, 4-142, 4-143, 

4-144, 146, 4-147, 4-148, 4-148, 4-149, 4-150, 4-151, 

4-152, 4-153, 4-154, 4-155, 4-156, 4-157, 157, 4-159, 

160, 161, 162, 4-163, 4-164, 165, 166, 4-167, 4-169, 4-

170, 4-171, 4-173, 4-174, 4-176, 4-177, 4-178, 4-179, 

4-181, 4-182, 4-186, 4-188, 4-190, 4-192, 4-193, 4-194, 

4-195, 4-196, 4-197, 4-198, 4-199, 4-200, 4-201, 4-202, 

4-203, 4-204, 4-205

SDS...............................................................................4-95

Seal 4-2, 4-5, 4-7, 4-14, 4-15, 4-20, 4-22, 4-35, 4-38, 4-41, 

4-42, 4-52, 4-80, 4-81, 4-86, 4-89, 4-92, 4-93, 4-94, 4-

95, 4-96, 4-97, 4-99, 4-100, 4-101, 4-102, 4-144, 4-149, 

4-151, 4-153, 4-154, 4-156, 160, 4-186, 4-202, 4-203

Seizure 4-1, 4-3, 4-4, 4-14, 4-16, 4-18, 4-30, 4-31, 4-44, 4-

60, 4-62, 4-77, 4-78, 4-82, 4-84, 4-173, 4-174, 4-197, 4-

200, 4-204
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 4-25 

4-185

Selective.....4-3, 4-8, 4-44, 4-46, 4-79, 4-89, 146, 4-156, 4-

163, 4-173, 4-174, 4-193, 4-199

Shipper 4-1, 4-5, 4-7, 4-12, 4-17, 4-23, 4-30, 4-39, 4-60, 4-

63, 4-64, 4-65, 4-72, 4-78, 4-83, 4-85, 4-98, 4-102, 4-

104, 4-156, 4-201

Shoes .................................................... 4-38, 4-133, 4-135

Size 4-26, 4-27, 4-28, 4-32, 4-35, 4-37, 4-39, 4-40, 4-43, 4-

45, 4-55, 4-57, 4-79, 4-87, 4-98, 4-100, 4-139, 4-141, 4-

142, 4-144, 146, 4-149, 4-151, 4-153, 4-154, 4-156, 4-

157, 157, 160, 161, 4-163, 4-164, 165, 166, 4-167, 4-

169, 4-171, 4-192, 4-193, 4-199, 4-200, 4-205

Split.........................................4-5, 4-7, 4-86, 4-103, 4-167

Storage.........................4-6, 4-44, 4-91, 4-94, 4-173, 4-204

Subsamples 4-6, 4-8, 4-18, 4-22, 4-26, 4-33, 4-43, 4-45, 4-

49, 4-52, 4-54, 4-55, 4-57, 4-79, 4-80, 4-93, 4-139, 4-

140, 4-143, 4-149, 4-150, 4-154, 161, 165, 4-174, 4-

176, 4-177, 4-178, 4-179, 4-180, 4-181, 4-199, 4-202

Surveillance...4-2, 4-21, 4-23, 4-25, 4-36, 4-37, 4-51, 4-73, 

4-86, 4-89, 146, 4-167, 4-188, 4-190, 4-193, 4-195

T

Tamper............................................................. 4-66, 4-101

Tampering....................4-2, 4-35, 4-62, 4-66, 4-100, 4-101

Territory....................................4-3, 4-13, 4-14, 4-60, 4-61

Testimony .......................................................... 4-40, 4-92

Thermometers........................................ 4-32, 4-99, 4-103

Tobacco ............4-13, 4-17, 4-33, 4-36, 4-70, 4-190, 4-195

Training............................................ 4-16, 4-48, 4-51, 4-57

Travel............................................. 4-24, 4-29, 4-37, 4-200

Travel Authorization................................................4-70

Travel Voucher...............................................4-28, 4-29

U

Undercover Buy.......................... 4-1, 4-2, 4-21, 4-29, 4-36

United States Code (U.S.C.)4-11, 4-12, 4-13, 4-15, 4-17, 4-

24, 4-25, 4-30, 4-32, 4-38, 4-39, 4-44, 4-59, 4-60, 4-61, 

4-62, 4-63, 4-64, 4-70, 4-79, 4-83, 4-89, 4-93, 4-139, 

146, 165, 4-173, 4-178, 4-180, 4-195, 4-196

USDA..................................................................160, 4-181

USPS...................................... 4-7, 4-22, 4-65, 4-102, 4-104

V

Vapor...........................................................................4-41

Vehicle ........................................... 4-13, 4-64, 4-65, 4-195

Violation 4-3, 4-9, 4-10, 4-12, 4-14, 4-15, 4-16, 4-17, 4-19, 

4-22, 4-23, 4-45, 4-57, 4-59, 4-60, 4-61, 4-62, 4-64, 4-

66, 4-73, 4-79, 4-82, 4-89, 4-178, 4-180, 4-193, 4-195, 

4-196, 4-198, 4-204

Viral .......................................................... 4-3, 4-56, 4-188

W

Warning Letter ............................................................4-16

Warrant ......................................... 4-2, 4-34, 4-178, 4-179

Water....4-33, 4-38, 4-42, 4-43, 4-46, 4-54, 4-86, 4-133, 4-

135, 4-136, 4-137, 4-138, 4-140, 4-142, 146, 4-151, 

160