INVESTIGATIONS OPERATIONS MANUAL 2023 CHAPTER 6

6-1 

CHAPTER 6 - IMPORTS

CONTENTS

CHAPTER 6 - IMPORTS .........................................................6-1

SUBCHAPTER 6.1 - IMPORTS ............................................6-2

6.1.1 - AUTHORITY ..............................................................6-2

6.1.2 – IMPORT INVESTIGATIONS .....................................6-3

6.1.3 - INVESTIGATIONS INVOLVING THE IMPORTATION 

PROCESS ............................................................................6-3

6.1.3.1 - Import Violation Patterns.........................................6-3

6.1.3.2 - Failure To Hold .......................................................6-3

6.1.3.3 - Failure To Hold – Health Hazards – Direct FDA 

Evidence ...............................................................................6-3

6.1.3.4 - Failure To Hold - Health Hazards – Detention Without 

Physical Examination (DWPE)..............................................6-3

6.1.3.5 - Substitution .............................................................6-3

6.1.3.6 - Importer Misdeclaration...........................................6-4

6.1.3.7 - Filer Misdeclaration.................................................6-4

6.1.3.7.1 - REPEATED FILER MISDECLARATION..............6-4

6.1.3.8 - Reporting Investigations Involving the Importation 

Process .................................................................................6-4

SUBCHAPTER 6.2 - IMPORT PROCEDURES ....................6-5

6.2.1 - SCOPE ......................................................................6-5

6.2.2 - DIVISION OF AUTHORITY........................................6-5

6.2.3 - ENTRIES ...................................................................6-5

6.2.3.1 - Formal Entries.........................................................6-5

6.2.3.2 - Informal Entries.......................................................6-5

6.2.3.3 - Mail/Personal Baggage...........................................6-5

6.2.3.4 – Import for Export (IFE) Entries ...............................6-5

6.2.3.4.1 – IFE ENTRY REVIEW ..........................................6-6

6.2.3.4.2 – DOMESTIC Follow-up of IFE entries...................6-6

6.2.3.4.3 – IFE DOMESTIC FOLLOW-UP INSPECTION 

GUIDANCE ...........................................................................6-7

6.2.3.5 - Prior Notice of Importation of Food and Animal Feed6-

7

6.2.3.5.1 - PRIOR NOTICE RECEPTION .............................6-7

6.2.3.5.2 - PRODUCTS REQUIRING PRIOR NOTICE.........6-7

6.2.3.5.3 - PRODUCTS EXCLUDED FROM PRIOR NOTICE 6-

7

6.2.3.5.4 - PRIOR NOTICE SUBMISSION............................6-8

6.2.3.5.5 - INADEQUATE PRIOR NOTICE SUBMISSION ...6-8

6.2.3.5.6 - PRIOR NOTICE PROCESS................................. 6-8

6.2.3.6 - Entry Processing.....................................................6-9

6.2.3.6.1 - U.S. CUSTOMS AND BORDER PROTECTION..6-9

6.2.3.6.2 - FDA......................................................................6-9

6.2.3.7 – VQIP Entry Processing.........................................6-10

6.2.4 - SAMPLING ..............................................................6-10

6.2.4.1 - Ports Covered by FDA ..........................................6-10

6.2.4.2 - Ports not Covered by FDA ....................................6-10

6.2.4.3 - Entry Sampling......................................................6-10

6.2.4.4 - Notice of Sampling................................................6-11

6.2.4.5 - Payment for Samples............................................6-11

6.2.5 - PROCEDURE WHEN PRODUCTS CANNOT BE 

SAMPLED OR EXAMINED.................................................6-11

6.2.6 - PROCEDURE WHEN NO VIOLATION IS FOUND..6-11

6.2.7 - PROCEDURE WHEN VIOLATION IS FOUND........6-11

6.2.7.1 - "Notice of Detention & Hearing"............................6-11

6.2.7.2 - Response to "Notice of Detention & Hearing".......6-12

6.2.7.3 - Request for Authorization to Relabel or Recondition 

Non-compliant Articles ........................................................6-12

6.2.7.4 - Inspection after Approved Reconditioning has been 

Completed...........................................................................6-12

6.2.7.5 - Procedure when Conditions of the Approved 

Reconditioning Application Have Been Fulfilled..................6-12

6.2.7.6 - Procedure when Conditions of the Approved 

Reconditioning Application Have Not Been Fulfilled ...........6-12

6.2.7.7 - Procedure after Hearing - "Notice of Release" ..... 6-12

6.2.7.8 - Procedure after Hearing - "Refusal of Admission" 6-12

6.2.7.9 - Payment of Costs of Supervision of Relabeling and/or 

Other Action........................................................................ 6-13

6.2.7.10 - Exportation of Goods Refused Admission.......... 6-13

6.2.7.11 - Bond Action........................................................ 6-13

6.2.8 – PHOTOGRAPHS: IDENTIFICATION AND STORAGE

........................................................................................... 6-13

SUBCHAPTER 6.3 – ENTRY REVIEW.............................. 6-14

6.3.1 - GENERAL ............................................................... 6-14

6.3.2 – INITIAL ENTRY REVIEW ....................................... 6-15

6.3.2.1 –Emergency and Perishable Shipments................. 6-15

6.3.2.2 – Reviewing Entry Data and Information ................ 6-15

6.3.2.2.1 – Manual “May Proceed” ..................................... 6-16

6.3.2.2.2 – Rescinding a “May Proceed” or IB Release...... 6-16

6.3.2.2.3 – Recommend Detention (DER/DTR).................. 6-17

6.3.2.2.4 – Request Examination and/or Sampling 

(LEX/FEX/SAM) .................................................................. 6-17

6.3.2.2.5 – Notices.............................................................. 6-17

6.3.2.2.6 – Cancelled Entries.............................................. 6-17

6.3.2.2.7 - Partner/Other Government Agency (OGA) Referral

........................................................................................... 6-17

6.3.3 – ENTRY DOCUMENTATION................................... 6-18

6.3.3.1 – Request of Entry Documents (DRQ).................... 6-18

6.3.3.2 – Receipt of Entry Documents ................................ 6-18

6.3.3.2.1 – Uploading documents received outside of ITACS 6-

18

6.3.3.3 – Review of Entry Documents ................................ 6-19

6.3.3.4 – Failure to Submit Entry Documents and Follow-up 

Requests ............................................................................ 6-19

6.3.4 – ENTRY DECISION ................................................. 6-19

6.3.5 - DETENTION RECOMMENDATIONS BY ENTRY 

REVIEWERS ...................................................................... 6-20

6.3.5.1 - Submission of Detention Recommendations to the 

Compliance Branch at the Entry Review Step.................... 6-20

6.3.5.2 - General Procedures Pertaining to all Detention 

Recommendations (DER and DTR) ................................... 6-20

6.3.5.2.1 - Entry Documents............................................... 6-20

6.3.5.3 - DER - Import Alert (IA) ......................................... 6-20

6.3.5.4 - DTR...................................................................... 6-21

6.3.5.4.1 - Similar to Import Alert........................................ 6-21

6.3.5.4.2 - Previous Violative Results (pending IA addition)6-21

6.3.5.4.2.1 Direct Reference Authority for DWPE.............. 6-22

6.3.5.4.2.2 - No Direct Reference Authority for DWPE....... 6-22

6.3.5.5 - Registration/Listing/Approval................................ 6-22

6.3.5.6 - IFE........................................................................ 6-22

SUBCHAPTER 6.4 - FIELD EXAMINATION ...................... 6-22

6.4.1 - GENERAL ............................................................... 6-22

6.4.2 - FIELD EXAMINATION SCHEDULE ........................ 6-23

6.4.3 - FIELD AND LABEL EXAMINATIONS – FOODS AND 

COSMETICS ...................................................................... 6-23

6.4.3.1 - Food Sanitation .................................................... 6-23

6.4.3.2 - Pesticides, Industrial Chemicals, Aflatoxins, & Toxic 

Elements ............................................................................ 6-24

6.4.3.3 - Food and Color Additives ..................................... 6-24

6.4.3.4 – Nutrition Labeling and Food Allergen Labeling.... 6-24

6.4.3.5 - Food Economics (On Consumer Size Containers 

only).................................................................................... 6-24

6.4.3.6 - Cosmetics............................................................. 6-24

6.4.4 - FIELD AND LABEL EXAMINATION – DRUGS....... 6-25

6.4.4.1 - Labeling................................................................ 6-25

6.4.4.2 - Contamination ...................................................... 6-25

6.4.4.3 - Samples ............................................................... 6-25

6.4.4.4 - Special Instructions .............................................. 6-25

6.4.5 - FIELD AND LABEL EXAMINATIONS – DEVICES .. 6-25

6.4.6 – FIELD AND LABEL EXAMINATIONS - BIOLOGICS.. 6-

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CHAPTER 6 INVESTIGATIONS OPERATIONS MANUAL 2023 

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6.4.7 - LABEL EXAMINATIONS - ANIMAL PRODUCTS ....6-26

6.4.7.1 – Animal Drugs........................................................6-26

6.4.7.2 – Animal Devices ....................................................6-26

6.4.7.3 - Animal Food..........................................................6-26

6.4.7.4 – Animal Grooming Aids..........................................6-27

6.4.7.5 – Animal Biological Products...................................6-27

6.4.8 - FIELD AND LABEL EXAMINATIONS -RADIOLOGICAL 

HEALTH ..............................................................................6-27

6.4.9 - FIELD EXAMINATIONS – TOBACCO PRODUCTS 6-27

6.4.10 – FIELD/LABEL EXAMINATION RESULTS.............6-27

6.4.10.1 – Date Completed .................................................6-28

6.4.10.2 – Location of goods...............................................6-28

6.4.10.3 – Remarks.............................................................6-28

6.4.10.4 – Summary............................................................6-28

6.4.10.5 – Exam Class ........................................................6-28

6.4.10.6 – Record Time.......................................................6-29

6.4.10.7 – Next Steps..........................................................6-29

SUBCHAPTER 6.5 - IMPORT SAMPLE COLLECTION .....6-29

6.5.1 - GENERAL ................................................................6-29

6.5.2 - PROCEDURES........................................................6-30

6.5.3 - TECHNIQUES .........................................................6-30

6.5.4 - IMPORT FORMS PROCEDURES...........................6-30

6.5.5 - SAMPLE COLLECTION REPORTS ........................6-30

6.5.5.1 - Collection Date......................................................6-31

6.5.5.2 - Episode................................................................. 6-31

6.5.5.3 - Submitted To.........................................................6-31

6.5.5.4 - Quantity Collected.................................................6-31

6.5.5.5 - Units......................................................................6-31

6.5.5.6 - DescText...............................................................6-31

6.5.5.7 - Hand Ship .............................................................6-31

6.5.5.8 - Remarks................................................................6-32

6.5.5.9 - Record Time Screen .............................................6-32

6.5.6 – Updating a Sample Collection Report .....................6-32

6.5.7- Special Domestic Import Samples (SDI)...................6-32

SUBCHAPTER 6.6 - FILER EVALUATIONS ......................6-33

6.6.1 - GENERAL ................................................................6-33

SUBCHAPTER 6.7 - GLOSSARY OF IMPORT TERMS ....6-33

6.7.1 - American Goods Returned.......................................6-33

6.7.2 - Bonded Warehouse .................................................6-33

6.7.3 - Break-Bulk Cargo.....................................................6-33

6.7.4 - Consumption Entry (CE) ..........................................6-33

6.7.5 – Container Freight Station (CFS)..............................6-33

6.7.6 - Date Collected .........................................................6-33

6.7.7 - Date of Arrival ..........................................................6-33

6.7.8 - Date of Availability ...................................................6-33

6.7.9 - Detention..................................................................6-33

6.7.10 - Detention Without Physical Examination (DWPE) . 6-33

6.7.11 - Domestic Import (DI) Sample................................. 6-34

6.7.12 - ENTRY...................................................................6-34

6.7.13 – ENTRY ADMISSIBILITY FILE...............................6-34

6.7.14 - Entry Documents (Entry Package).........................6-34

6.7.15 – FAILURE TO HOLD ..............................................6-34

6.7.16 - FILER .....................................................................6-34

6.7.17 - Formal Entry ..........................................................6-34

6.7.18 - Foreign Trade Zones .............................................6-34

6.7.19 - Immediate Delivery (ID)/ Conditional Release .......6-34

6.7.20 - Import Alerts...........................................................6-34

6.7.21 - Importer of Record .................................................6-34

6.7.22 - Import Sections ......................................................6-34

6.7.23 - Import Status..........................................................6-34

6.7.24 – IMPORTER MISDECLARATION ..........................6-34

6.7.25 - Informal Entry.........................................................6-35

6.7.26 – Immediate Transportation (IT)...............................6-35

6.7.27 - Line (Line Item)......................................................6-35

6.7.28 - LOT........................................................................6-35

6.7.29 - MARKS ..................................................................6-35

6.7.30 - Port (Point) of Entry ...............................................6-35

6.7.31 - Redelivery Bond (AKA Entry Bond) .......................6-35

6.7.32 - Stripping (Of Containers) .......................................6-35

6.7.33 – SUBSTITUTION ....................................................6-35

6.7.34 - Supervisory Charges............................................. 6-35

6.7.35 - Warehouse Entry (WE).......................................... 6-35

6.7.36 – VQIP QUALITY ASSURANCE PROGRAM .......... 6-35

6.7.37 – FSVP AND/OR HACCP IMPORTER.................... 6-35

6.7.38 – DATA UNIVERSAL NUMBER SYSTEM (DUNS) . 6-35

6.7.39 – FOOD SAFETY MODERNIZATION ACT (FSMA) 6-36

6.7.40 – FOREGIN SUPPLIER VERFICATION PROGRAM 

(FSVP) ................................................................................ 6-36

SUBCHAPTER 6.8 FOREIGN SUPPLIER VERIFICATION 

PROGRAM......................................................................... 6-36

6.8.1 - FSVP INSPECTIONS.............................................. 6-36

6.8.1.1 - Pre-Inspection Activities ....................................... 6-36

6.8.1.2 - Preparation and References................................. 6-36

6.8.1.3 - Inspectional Authority ........................................... 6-36

6.8.1.4 - FSVP Inspectional Activities................................. 6-36

6.8.1.4.1 - CONDUCTING THE FSVP RECORDS REVIEW.. 6-

37

6.8.2 - FSVP OBSERVATIONS .......................................... 6-37

6.8.2.1 - Preparation of Form FDA 483a ............................ 6-37

6.8.2.1.1 - INDIVIDUAL HEADINGS................................... 6-38

6.8.2.1.2 - SIGNATURE POLICY ....................................... 6-38

SUBCHAPTER 6.9– FSVP REPORTING .......................... 6-38

6.9.1– ESTABLISHMENT INSPECTION REPORT (EIR)... 6-38

6.9.1.1- FSVP RECORDS REVIEW................................... 6-38

6-1 Notice of FDA Action .................................................... 6-40

6-2 FORM FDA 766 – Application for Authorization to Relabel 

or Recondition Non-Compliant Articles............................... 6-44

6-3 Form FDA 790 Charges for Supervision ...................... 6-46

6-4 Sample Collection in OASIS Screen Shot .................... 6-47

6-5 FORM FDA 463a AFFIDAVIT ...................................... 6-48

SUBCHAPTER 6.1 - IMPORTS 

6.1.1 - AUTHORITY 

Section 801 of the FD&C Act [21 U.S.C. 381] authorizes 

FDA examination of foods, drugs, cosmetics, devices, and 

tobacco products offered for entry into the United States. 

Section 536 of the FD&C Act [21 U.S.C. 360mm] authorizes 

refusal of radiation emitting products which fail to comply 

with the requirements of Section 534 (h) of the FD&C Act

[21 U.S.C. 360kk (h)]. 19 CFR 151.4 of the U.S. Customs 

and Border Protection (CBP) regulations authorizes 

employees of FDA to examine or take samples of entry 

goods released under immediate delivery.

The procedures outlined in this chapter cover imported 

goods subject to, but not limited to, the following 

Acts/Regulations:

1. Federal Food, Drug, and Cosmetic Act (FD&C)

2. Fair Packaging and Labeling Act (FPLA)

3. Nutrition Labeling and Education Act (NLEA)

4. Import Milk Act/ Filled Milk Act

5. Federal Caustic Poison Act Bioterrorism Act

6. Public Health Service Act, Part, Part F, Subpart 1, 

Biologic Products

7. Title 21 CFR Subpart E - Imports and Exports (1.83), 

etc.

8. Title 19 CFR Customs Duties (authority to sample 

delegated by CBP Regulations, etc.)

9. Federal Cigarette Labeling and Advertising Act

Comprehensive Smokeless Tobacco Health 

Education Act

10. Family Smoking Prevention and Tobacco Control Act
INVESTIGATIONS OPERATIONS MANUAL 2023 CHAPTER 6

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6.1.2 – IMPORT INVESTIGATIONS 

Import operations, normally focus on entry review, field 

examinations, and sample collections. However, 

investigations are an essential tool in uncovering and 

developing evidence documenting violations such as entry 

misdeclaration, product substitutions, and “port shopping.” 

Invaluable sources of information include: Import Alerts, 

assignments from headquarters or other districts, 

interagency cooperation and local intelligence.

When documenting these situations, your supervisor may 

request a memo of investigation or an Establishment 

Inspection Report (EIR) to be sent to the compliance 

branch. Follow your district procedures, IOM Chapter 5 for 

preparation of the EIR and IOM Subchapter 8.1.9. for 

preparation of memorandums. 

When examining, sampling, or following up on refused 

imported products you may use an affidavit to document the 

facts surrounding the situation. Refer to IOM 4.4.5 and 

Exhibit 6-5 for guidance on preparation of an affidavit. 

6.1.3 - INVESTIGATIONS INVOLVING THE 

IMPORTATION PROCESS 

During the importation process, FDA personnel encounter 

attempts to bypass proper FDA record review, inspection 

and/or sampling as well as the willful attempt to import 

goods known to violate the Act. In addition to FDA 

detention, refusal, and placement onto an Import Alert, 

FDA performs investigations and forwards the evidence 

collected to support a recommendation for CBP sanction 

under Title 19 which include administrative seizures, civil 

money penalties, revocation of conditional release 

privileges, and bond actions (liquidated damages, 

increases to bond amount, requirement of singletransaction bond).

6.1.3.1 - Import Violation Patterns 

The below investigational points should be covered to 

promote a thorough investigation. Any given situation 

may overlap into more than one pattern. While not an 

exhaustive list, the following four patterns may be 

encountered: 

1. Failure to hold (See IOM 6.1.3.2) 

2. Substitution (See IOM 6.1.3.5) 

3. Importer misdeclaration (See IOM 6.1.3.6) 

4. Filer misdeclaration (See IOM 6.1.3.7)

6.1.3.2 - Failure To Hold 

‘Failure to hold’ means that the goods have been distributed 

by the importer/consignee without an FDA release from 

import status. Please note that this is defined as 

distribution without a release, not merely moving the goods 

outside of the port area. FDA personnel may encounter this 

situation at various points in the importation process 

including initial exam/inspection, sample collection, audit 

sample collection, reconciliation examination after a health 

hazard finding, verification of a reconditioning, and refusal 

verification. The following steps should be taken on all 

failure to hold cases:

1. Collect entry documentation (CBP form 3461 or 7501, 

invoice, packing list, bill of lading). 

2. Determine distribution - collect and analyze pertinent 

distribution records.

3. Determine who authorized the distribution. (There may 

be more than one responsible party.)

4. Determine if the importer was aware of the health 

hazard associated with the product.

5. Obtain the authorizing person’s explanation as to why 

the goods were distributed. Items (1), (2), (3), (4), and 

(5) should be covered in one or more affidavits.

6. Perform a data search via ORADSS or other means to 

determine the importer’s history and discuss relevant 

findings with supervisory and compliance staff.

7. Coordinate with CBP the issuance of a Demand for 

Redelivery (form 4647) if one has not already issued per 

a refusal. Form 4647 can be issued for the purposes of 

examination/sampling, not merely as a result of an FDA 

refusal. In such circumstances, the deadline for 

redelivery is 30 days instead of the 90 days post-refusal. 

8. Determine the importer’s bond type and amount.

6.1.3.3 - Failure To Hold – Health Hazards 

– Direct FDA Evidence 

Distribution of goods where there is direct evidence of a 

significant health hazard, such as an FDA finding of 

Salmonella contamination in a ready-to-eat food entry, 

should be regarded as a concern of the highest priority. In 

addition to the eight common elements listed above, the 

following additional step should be taken: 

• Consult with supervisory staff, compliance staff, 

and the district’s Recall and Emergency 

Coordinator as needed to address retrieval from 

and/or notification to the consignees, as well as 

consideration for any public warning.

6.1.3.4 - Failure To Hold - Health Hazards 

– Detention Without Physical 

Examination (DWPE) 

Distribution of goods where there is evidence of a 

significant health hazard which only meets the appearance 

of a violation evidentiary standard (the standard under the 

801(a) admissibility process) such as an entry of a readyto-eat food detained without physical examination (DWPE) 

due to a history of Salmonella contamination, should be 

regarded as a concern of high priority. In addition to the 

eight common elements listed above, the following 

additional steps should be taken: 

1. Consult with supervisory staff and compliance staff as 

needed to determine if the FDA should collect samples 

for analysis.

2. Consult with supervisory staff, compliance staff, and the 

district’s Recall and Emergency Coordinator as needed 

to address retrieval from and/or notification to the 

consignees, as well as consideration for any public 

warning.

6.1.3.5 - Substitution

Substitution is an attempt by the importer or importer’s 

agent to present goods to FDA as corresponding to a 

particular entry when they are in fact not the goods from 
CHAPTER 6 INVESTIGATIONS OPERATIONS MANUAL 2023

6-4

that entry. FDA personnel may encounter this situation at 

various points in the importation process including initial 

exam/inspection, sample collection, audit sample 

collection, reconciliation examination after a health hazard 

finding, verification of a reconditioning, and redelivery 

examination. Substitution may occur as an attempt to hide 

distribution without FDA release (Failure to Hold). The 

investigation may reveal negligence, gross negligence or 

fraud. The following steps should be taken when evidence 

of substitution is encountered:

1. Confirm that the goods are being presented to FDA as 

corresponding to a particular entry. In some situations,

you may only be able to show associated entry 

documents to the importer or importer’s agent and 

request confirmation that the goods presented 

correspond to that entry. Confirmation can be 

accomplished by performing the following steps:

a. Collect all available evidence supporting the 

presented goods were substituted. This may include 

labeling, lot codes, and the condition of the goods 

themselves. Photos are invaluable. Examination of 

the entire shipment would minimize the possibility 

the importer will be able to successfully claim that the 

portion not examined was in fact not substituted. 

b. Collect all available evidence to show any attempt to 

conceal the substitution. For example, in a partially 

substituted entry the substituted goods are in the 

center, bottom position on a pallet, or placement of 

the substituted goods is in the front position of the 

trailer. 

2. Determine the importer’s or importer’s agent’s 

explanation for the discrepancies. Collect this in an 

affidavit along with a description of the declared/actual 

goods and the substituted goods.

3. Until it is determined otherwise, consider all substitution 

cases to involve distribution of the actual goods without 

FDA release. See IOM 6.1.3.2 FAILURE TO HOLD.

6.1.3.6 - Importer Misdeclaration

Importer misdeclaration refers to the importer’s provision of 

incorrect and/or incomplete information to FDA and CBP, 

usually via the filer. When FDA personnel encounter this 

situation, it is usually during the initial examination or 

sampling of the entry. It may be the case that the 

investigation reveals negligence, gross negligence or fraud. 

The following examples may apply:

 

1. The importer provides information to the filer that does 

NOT include a product that is actually present in the 

entry and as a result that product is not included in the 

declaration (undeclared goods).

2. The importer provides the filer information that a product 

is manufactured by firm X, when it is in fact 

manufactured by firm Y. As a result, the filer declares 

the product as manufactured by firm X (mis declared

goods). 

6.1.3.7 - Filer Misdeclaration

Although this section is oriented to filer interventions, it 

must always be recognized the filer is the agent of the 

importer and the importer is ultimately responsible. Filer 

misdeclaration refers to the importer’s provision of correct 

information to the filer who then files an erroneous entry to 

(CBP). The following examples may apply: 

1. The filer omits a product properly listed on the entry 

invoice from the declaration (undeclared goods). 

2. The importer provides the filer information that a product 

is manufactured by firm X, but the filer declares it as 

manufactured by firm Y (mis declared goods). 

3. The importer provides an invoice to the filer that lists 

product X, but the filer declares product Y. When FDA 

personnel encounter this situation, it is usually during 

the initial examination or sampling of the entry (mis 

declared goods).

4. The filer selects a food Process Identification Code 

(PIC) for packaged food (which should only be selected 

when no other PIC applies, per the instructions of the 

FDA’s Product Code Builder on the Web) when the 

broker does not have sufficient information to determine 

if any other PIC applies (mis declared goods). 

6.1.3.7.1 - REPEATED FILER 

MISDECLARATION

In the event a filer continues to mis-declare a product to 

CBP or FDA and/or continues to introduce or present to 

CBP or FDA any erroneous types of documentation which 

may violate the FD&C Act; the following steps should be 

taken:

1. Document what information was available to the filer to 

file the entry. Collect any relevant records not already 

obtained.

2. Document the undeclared or mis declared products 

through the collection of labeling and/or photos. 

3. Obtain the filer’s explanation for the discrepancies. 

Collect this in an affidavit along with (1).

4. It may be necessary to also collect an affidavit from the 

importer in some fact patterns. For example, if a filer 

declares a cosmetic product code for fluoridated 

toothpaste because the importer failed to provide the 

filer information about whether the toothpaste did or did 

not contain fluoride, it may be necessary to collect that 

information via an affidavit from the importer.

5. A Filer Evaluation should be conducted to examine 

records and to determine the extent of the problem. FDA 

should gather enough evidence to support a possible 

broker penalty and the following should be considered: 

a. If the filer has no history of filing erroneous entries to 

FDA, Districts should consider further training and or 

placing the filer back to phase 1 filing status and 

withhold a request to assess a broker penalty against 

the filer. 

b. If the filer has a history of filing erroneous entries to 

FDA and the filer continues to disregard FDA’s 

attempts to provide guidance, train, and document 

guidance provided of filing entries through the 

Automated Broker Interface (ABI), FDA should 

contact (CBP) to request a broker penalty be 

assessed against the filer. 

6.1.3.8 - Reporting Investigations 

Involving the Importation Process

An investigational memo with supervisory endorsement 

should be generated for all instances described under IOM 

6.1.3.1 (import violation patterns), IOM 6.1.3.7 (filer 
INVESTIGATIONS OPERATIONS MANUAL 2023 CHAPTER 6

6-5 

misdeclaration), IOM 6.1.3.5 (substitution) and IOM 6.1.2

(import investigations). The memo should normally be 

provided to supervisory staff for endorsement within ten 

business days of the last investigational activity. The memo 

should normally be endorsed by supervisory staff within five 

business days. Memos that are endorsed for regulatory 

consideration should then be forwarded to Compliance for 

further follow-up. If no memo is generated, then the 

importer and/or broker should be advised, and that 

advisement should be documented in accordance with 

district policy.

SUBCHAPTER 6.2 - IMPORT 

PROCEDURES 

6.2.1 - SCOPE 

The procedures in this section cover imported goods. Your 

personal safety during any import procedures outlined in 

this subchapter is important. For more information 

concerning personal safety, see IOM 5.2.1.2.

6.2.2 - DIVISION OF AUTHORITY 

FDA determines if an article is in compliance with the Acts

it enforces. It also determines whether or not the article can 

be brought into compliance with the appropriate statute and 

authorizes reconditioning for that purpose.

Supervision over the reconditioning is exercised by either 

FDA or CBP as mutually arranged. At ports in reasonably 

close proximity to an FDA office, supervision is ordinarily 

exercised by FDA. At remote ports supervision may be 

exercised by CBP. 

The refusal of admission, exportation, or destruction of 

goods is carried out under the direction of Customs. 

However, at some ports the actual supervision of the 

destruction of violative goods may be conducted by FDA 

pursuant to a local FDA/Customs agreement.

6.2.3 - ENTRIES 

6.2.3.1 - Formal Entries 

All articles offered for entry into the U.S. and subject to the 

Acts enforced by FDA, with a value greater than $2,500 

(current), are considered formal entries. They are subject 

to bond requirements, which include a condition for the 

redelivery of the goods, or any part of it, upon demand by 

CBP at any time, as prescribed for in the CBP regulations 

in force on the date of entry. (section 801(b) of the FD&C 

Act [21 U.S.C. 381(b)], 19 CFR Part 113) The bond is filed 

with CBP which, in case of default, takes appropriate action 

to effect the collection of liquidated damages provided for 

in the bond after consultation with FDA. (19 CFR Section 

113.62and 21 CFR Section 1.97).

Notification of the CBP entry is generally accomplished by 

electronic submission through the CBP Automated 

Commercial Environment (ACE). Non-electronic entries are 

submitted directly to FDA. Electronic entries received by 

FDA may be subject to on screen review (OSR) to 

determine if further action is needed, or if full 

documentation must be submitted. For entries requiring 

further review, FDA will be provided the appropriate CBP

Entry documents (CF 3461/3461ALT, commercial invoice, 

bill of lading and any other relevant documents to aid in 

making an admissibility decision), which also document 

interstate commerce. If an entry is not filed electronically, 

these documents will be submitted to FDA at the time CBP

entry is made, in accordance with local port operations.

6.2.3.2 - Informal Entries 

Normally, informal entries (value less than $2,500 currently) 

do not require posting a redelivery bond. All informal entries 

of articles subject to FDA jurisdiction, entered electronically, 

are forwarded to FDA through the CBP/FDA ACE interface. 

When FDA takes action on an informal entry not filed 

electronically by the filer, FDA personnel will input the 

informal entry into FDA import systems (ER,SERIO, 

OASIS) as a manual entry. When taking FDA action with an 

informal entry, CBP will be requested to convert it into a 

formal consumption entry.

6.2.3.3 - Mail/Personal Baggage 

In the case of imports by mail or personal baggage, FDA 

districts should arrange for coverage with their local CBP

International Mail Office or border crossing office. This 

should include agreements designating who is responsible 

for coverage, when (how often), etc. CBP is responsible for 

examination of personal baggage. If an article subject to 

FDA review is encountered, the CBP officer will determine 

if it should be brought to the attention of the local FDA 

office. Personal importations meeting the criteria of a formal 

entry will be processed in accordance with normal nonelectronic entries. Generally, since most personal 

importations are small in size and value, guidance has been 

developed for evaluating these importations. (See RPM 

Chapter 9-2"Coverage of Personal Importations".)

"Section 321 entries" for CBP are those entries with a value 

of $800 or less. Generally, this form of entry applies to 

articles which pass free of duty and tax, and are imported 

by one person, on one day (19 C.F.R. 101.1 (o)). CBP and 

FDA may conduct periodic "blitzes" to determine the 

volume and type of FDA-regulated goods admitted under 

"Section 321 entries." The use of the 321 entry process 

should not apply to multiple shipments covered by a single 

order or contract, sent separately for the express purpose 

of securing free entry and avoiding compliance with 

pertinent law or regulation.

6.2.3.4 – Import for Export (IFE) Entries 

PRODUCTS IMPORTED UNDER THE PROVISIONS OF 

SECTION 801(d)(3) OF THE FD&C Act [21 U.S.C. 381 

(d)(3)]: Import For Export (IFE) Processing and Follow-Up

PURPOSE: To establish procedures facilitating the 

uniform review and admissibility process of Import for 

Export (IFE) entries at the time of entry and sufficient 
CHAPTER 6 INVESTIGATIONS OPERATIONS MANUAL 2023 

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notification for domestic follow up of Import for Export

shipments. 

REFERENCES: Regulatory Procedures Manual Chapter 

9-17, Federal Food, Drug, and Cosmetic Act

BACKGROUND: Section 801(d)(3) of the FD&C Act [21 

U.S.C. 381 (d)(3)] allows the importation of certain 

violative FDA-regulated articles into the U.S. on a 

conditional basis ensuring that they are not for domestic 

distribution. Those articles include human and veterinary 

drugs (or their components); device components or 

accessories, or other devices requiring further processing 

for health-related purposes; and food additives, color 

additives and dietary supplements including in bulk form. 

They must be explicitly intended for further processing or 

incorporation into other products and subsequent export.

Documentation required at the time of importation under 

section 801(d)(3) of the Act [21 U.S.C. 381 (d)(3)] 

includes:

1. A statement that article is intended to be further 

processed or incorporated into a drug, biologics 

product, device, food, food additive, color additive or 

dietary supplement that will be exported under 

sections 801(e)or 802 of the FD&C Act [21 U.S.C. 381 

(e) or 382] or section 351(h) of the Public Health 

Service Act (PHSA);

2. Information to identify the manufacturer of the article 

and each processor, packer, distributor, or other entity 

in chain of possession from manufacturer to importer;

3. Such certificates of analysis as necessary to identify 

the article, unless it is a device or falls under section 

801 (d)(4) of the FD&C Act [21 U.S.C. 381 (d)(4)] - 

blood and blood components;

In addition, a good and sufficient bond must be executed 

providing for payment of liquidated damages in 

accordance with CBP requirements. Refer to RPM 9-17. 

NOTE: Some entry types may not be accompanied by a 

bond. For 2. above, attempt to obtain name and address 

of each entity in the chain of possession if not already 

provided with the supporting documentation.

6.2.3.4.1 – IFE ENTRY REVIEW 

Import for Export entry procedures are as follows:

1. Divisions should ensure all of the information required 

under section 801(d)(3) FD&C Act [21 U.S.C. 381 

(d)(3)] is provided and supporting documents are 

uploaded (if not already received from the broker or 

importer). Confirm that IFE or suspected IFE 

entry/lines are submitted with an intended use code 

(IUC) “Import for Export” and with the IFE in the 

Affirmation of Compliance (AofC). For entry/lines which 

lack complete supporting documents, request 

documents per IOM 6.3.3. 

a. If the required documentation is not provided 

after the document(s) is(are) requested, entry 

reviewers should request detention indicating 

the products do not meet the regulatory 

requirements, are being offered for import 

using the IFE provisions, and the required IFE 

documentation was not provided to FDA at the 

time of initial importation. Refer to RPM 9-17-3 

for additional information.

2. If all required documentation is provided and the 

conditions required by section 801(d)(3) FD&C Act [21 

U.S.C. 381 (d)(3)] have been met, including the correct 

AofC and IUC, a “May Proceed” may be issued. NOTE: 

Ensure that all entry documentation has been 

uploaded to the entry/line prior to making an 

admissibility decision. 

a. If the entry/line was transmitted as an IFE, but 

review of the entry/line information or supporting 

documentation indicates that the articles are not 

intended to be further processed and exported per 

section 801(d)(3) of the Act [21 U.S.C. 381 (d)(3): 

• Update the entry/line with appropriate IUC and 

AofCs, as appropriate

• Record the reason for update, save and 

rescreen the entry/line

• Review the entry/line according to applicable 

requirements

6.2.3.4.2 – DOMESTIC Follow-up of IFE 

entries 

In preparation for a domestic inspection of the initial owner 

or consignee, the domestic division should:

1. Review entry/line data and entry documents from the 

“Import for Export Entry Lines and Documents Past 2 

Years“ report located at 

http://oradss.fda.gov:8085/reports/ora/diop/ife/ to 

determine if the firm has records of IFE entry/lines . 

The entry/line data can be found in the commodity 

specific worksheets. Links to the entry/line documents 

can be found in the “Links-[commodity]” worksheets. 

Ex. (“Links-Med Dev Rad Health” will contain the 

entry/line number, consignee/importer information and 

the document links. Additionally, the link to the report 

can also be found on the OIO intranet site at Import 

For Export (IFE) (sharepoint.com). 

2. If IFE entry/lines are noted in the report, follow-up of 

IFE entry/lines should be done during the initial owner 

or consignee domestic inspection. IFE entry/lines for 

the firm should be investigated during the inspection as 

outlined in section 6.2.3.4.3. 
INVESTIGATIONS OPERATIONS MANUAL 2023 CHAPTER 6

6-7 

6.2.3.4.3 – IFE DOMESTIC FOLLOW-UP 

INSPECTION GUIDANCE

During the domestic inspection, follow-up on the IFE 

entry/lines as described below: 

1. IFE entry/line information and documentation can be 

obtained through the “Import for Export Entry Lines and 

Documents Past 2 Years” report located at 

http://oradss.fda.gov:8085/reports/ora/diop/ife/

2. Verify during the inspection if the IFE article(s): 

a. Was used to produce an exported product,

b. Was destroyed, or

c. Is still under the firm’s control pending disposition. If 

the article is pending disposition, verify whether the 

article exists, and the article is the same article that 

was offered for entry (per supporting 

documentation). 

3. If the article was exported or destroyed, request the 

manufacturer's import, export, and/or destruction 

records to verify the imported article was further 

processed or incorporated into another product and was 

exported in accordance with sections 801 (e) or 802 of 

the FD&C Act [21 U.S.C. 381 (e) or 382] or section 

351(h) of the PHSA, or destroyed. For drug products, an 

initial owner or consignee may be allowed to retain a 

sample of the imported article in order to comply with 

good manufacturing practices (GMP) regulations 

concerning sample retention.

Upon completion of the inspection, ensure the following 

actions are taken:

1. Document the status of the IFE product and if further 

follow-up is required in the Establishment Inspection 

Report (EIR) or a memo.

2. If further follow-up actions are needed, schedule a 

follow-up inspection or discuss with the Office of Import 

Operations (OIO), Division of Import Operations (DIO), 

to determine appropriate actions at the import level. If 

further follow-up is NOT needed, document the 

completed follow-up in the EIR or Memo. 

3. Any inspections identifying a prohibited act under 

section 301(w) of the FD&C Act [21 U.S.C. 331 (w)] 

should be forwarded immediately to the applicable 

program area director (DIB or DCB) for regulatory 

action. See RPM Chapter 9. In addition, a copy of the 

violative inspection findings should be forwarded to OIO

DIO. 

6.2.3.5 - Prior Notice of Importation of 

Food and Animal Feed 

The Public Health Security and Bioterrorism Preparedness 

and Response Act of 2002 (the Bioterrorism Act) requires 

that FDA receive prior notice of food imported into the 

United States. Most of the prior notice information required 

by the final rule is data usually provided by importers or 

brokers to CBP when foods arrive in the United States. The 

Bioterrorism Act requires that this information also be 

provided to FDA prior to an imported article of food’s arrival 

to the United States. FDA uses this data in advance of the 

arrival of the article of food to review and assess the prior 

notice data and determine whether to examine the imported 

food for potential contamination by bioterrorism act or 

significant public health risks. Prior notice can be submitted 

either through ABI/ACE or FDA's Prior Notice System 

Interface (PNSI). 

6.2.3.5.1 - PRIOR NOTICE RECEPTION 

Prior notice for food articles subject to the rule must be 

received and confirmed electronically by FDA no more than 

15 calendar days before the anticipated date of arrival for 

submission made through the PNSI and no more than 30 

calendar days before the anticipated date of arrival for 

submission made through ABI/ACE, and as specified by the 

mode of transportation below, no fewer than:

1. 2 hours before arrival by land by road

2. 4 hours before arrival by air or by land by rail

3. 8 hours before arrival by water

In addition, prior notice must be received and confirmed 

electronically by FDA before food is mailed by international 

mail. (The parcel must be accompanied by confirmation of 

FDA receipt of prior notice.)

6.2.3.5.2 - PRODUCTS REQUIRING PRIOR 

NOTICE 

Prior notice applies to food for humans and other animals 

that is imported or offered for import into the United States. 

For purposes of prior notice requirements, "food" is defined 

by reference to section 201(f) of the Federal Food, Drug, 

and Cosmetic Act. Section 201(f) defines "food" as articles 

used for food or drink for man or other animals, chewing 

gum, and articles used for components of any such articles.

Examples of "food" include:

1. Dietary supplements and dietary ingredients

2. Infant formula

3. Beverages (including alcoholic beverages and bottled 

water)

4. Fruits and vegetables

5. Seafood

6. Dairy products and eggs

7. Raw agricultural commodities for use as food or 

components of food

8. Canned and frozen foods

9. Bakery goods, snack food, and candy (including 

chewing gum)

10.Live food animals

11.Animal feeds and pet food

6.2.3.5.3 - PRODUCTS EXCLUDED FROM 

PRIOR NOTICE 

Foods that are excluded from the prior notice requirement 

are: 

1. Food carried by or otherwise accompanying an 

individual arriving in the United States for that 

individual's personal use (i.e., for consumption by 
CHAPTER 6 INVESTIGATIONS OPERATIONS MANUAL 2023 

 6-8 

themselves, family, or friends, and not for sale or other 

distribution);

2. Food that is exported without leaving the port of arrival 

until export;

3. Meat food products, poultry products and egg products 

that are subject to the exclusive jurisdiction of the U.S. 

Department of Agriculture (USDA) under the Federal 

Meat Inspection Act (21 USC 601), (21 USC 601), the 

Poultry Products Inspection Act, or the Egg Products 

Inspection Act; 

4. Food that was made by an individual in his/her personal 

residence and sent by that individual as a personal gift 

(i.e., for non-business reasons) to an individual in the 

United States; and

5. Articles of food subject to Art. 27 (3) of the Vienna 

Convention on Diplomatic Relations (1961), (1961), i.e. 

shipped as baggage or cargo constituting the diplomatic 

bag.

6.2.3.5.4 - PRIOR NOTICE SUBMISSION 

The prior notice must be submitted electronically and 

contain the following information in accordance with 21 

CFR 1.281: 

1. Identification of the submitter, including name, 

telephone number, email address, and firm name and 

address 

2. Identification of the transmitter (if different from the 

submitter), including name, telephone number, email 

address, and firm name and address. If the business 

address of the individual transmitting the prior notice is 

a registered facility, then the facility’s registration 

number, city, and country may be provided instead of 

the facility’s full address

3. Entry type and CBP entry identifier, if available

4. The identification of the article of food, including 

complete FDA product code, the common or usual 

name or market name, the estimated quantity 

described from the largest container size to the 

smallest package, and the lot or code numbers or other 

identifier (if applicable)

5. If the food is no longer in its natural state (21 CFR 

1.276(b)(10)), name of the manufacturer and either (1) 

The registration number, city and country of the 

manufacturer or (2) both the full address of the 

manufacturer and the reason the registration number is 

not provided

6. If the food is in its natural state, the name of grower, if 

known, and growing location

7. The FDA Country of Production

8. The identification of the shipper, express consignment 

operators, carriers, other private delivery service or 

sender’s if the food is mailed. This is to include the 

name and full address of the shipper, if the shipper is 

different from the manufacturer. If the address of the 

shipper is a registered facility, the submitter may submit 

the registration number of the shipper’s registered 

facility city and country instead of the facility’s full 

address

9. The country from which the article of food is shipped. If 

the food is imported by international mail, the 

anticipated date of mailing and country from which the 

food is mailed

10. The anticipated arrival information (location, date, and 

time). If the food is imported by international mail, the 

U.S. recipient (name and address). If the article of food 

is arriving by express consignment operator or carrier, 

and neither the submitter nor transmitter is the express 

consignment operator or carrier, and the prior notice is 

submitted via PNSI, the express consignment operator 

or carrier tracking number may be submitted in lieu of 

the anticipated arrival information. For post-refusal 

submissions, actual date the article arrived is required

11. The identification and full address of the importer, 

owner, and ultimate consignee, except for food 

imported by international mail or transshipped through 

the United States. If the business address of the 

importer, owner, or ultimate consignee is a registered 

facility, then the facility’s registration number also may 

be provided in addition to the facility’s full address

12. The identification of the carrier and mode of 

transportation, except for food imported by international 

mail

13. Planned shipment information is applicable by mode of 

transportation and when it exists. For food arriving by 

express consignment operator or carrier, when neither 

the submitter nor transmitter is the express 

consignment operator or carrier, the tracking number 

can be submitted in lieu of the Bill of Lading or Airway

Bill number and the flight number for prior notices 

submitted via PNSI

14. The name of any country to which the article of food 

has been refused entry.

6.2.3.5.5 - INADEQUATE PRIOR NOTICE 

SUBMISSION 

Food that is imported or offered for import with inadequate 

prior notice is subject to refusal and holding at the port or in 

secure storage facility. FDA provided guidance to its

stakeholders and CBP staff on enforcing the prior notice 

requirements in a Compliance Policy Guide, Prior Notice of 

Imported Food Under the Public Health Security and 

Bioterrorism Preparedness and Response Act of 2002 at 

https://www.fda.gov/food/importing-food-products-unitedstates/prior-notice-imported-foods. This guidance, 

however, does not affect FDA's ability to take actions that 

may be necessary, including conducting inspections for 

food safety and security concerns or taking any other action 

under the Federal Food, Drug, and Cosmetic Act. This 

policy will also not affect the ability of CBP to assess 

penalties under 19 U.S.C. 1595a (b) or to take enforcement 

action under any other authority.

6.2.3.5.6 - PRIOR NOTICE PROCESS 

The prior notice process begins with an automated 

screening process. If additional evaluation of the prior 

notice information is necessary, all review of prior notice 

information is performed by the Division of Food Defense 

Targeting (DFDT); FDA headquarters staff, operating 24 

hours a day, 7 days a week. The review process is a 
INVESTIGATIONS OPERATIONS MANUAL 2023 CHAPTER 6

6-9 

manual review by the DFDT. It is designed to identify food 

products that may pose serious risks to public health so that 

appropriate action can be taken upon arrival of article of 

food in the United States. The review process is not 

impacted by the method of electronic submission. The 

results of this process are transmitted to CBP.

The DFDT reviews and assesses the prior notice 

information and may initiate an examination or other action 

by FDA or CBP of the article of food at the port of arrival or 

elsewhere, or in the case of rail shipments, within the 

confines of the closest appropriate examination site. The 

DFDT will advise the FDA field offices and/or CBP of the 

inspection requirements. The DFDT is also responsible for 

communication with submitters regarding the compliance of 

prior notice, the initiation of refusal or hold due to 

inadequate prior notices, the response to requests for 

review of refusals or holds, and the completion of the prior 

notice process.

In addition to the prior notice process, the OASIS system 

review will determine if further staff evaluation of the article 

of food is necessary for admissibility determinations under 

section 801(a) of the FD&C Act (e.g., subject to the 

guidance in an import alert). If the food meets the prior 

notice requirements; the food will be subject to further 

review by FDA staff for determination of admissibility under 

section 801(a) of the FD&C Act.

This admissibility examination may take place at the border 

but may also take place at an examination site, a public 

warehouse, or other appropriate locations. If FDA 

determines that refusal under section 801(a) of the FD&C 

Act is appropriate, the appropriate refusal procedures will 

be used.

6.2.3.6 - Entry Processing 

FDA division offices generally receive notification of all 

formal and informal entries subject to FDA's jurisdiction. 

Management for each port of entry determines coverage, 

hours of operation and resource allocation for any office 

closures impacting normal working hours. In addition, 

FDA’s import systems allow for entries to be reviewed 

remotely by off-site personnel. 

Entries submitted electronically to FDA are screened 

against criteria established by FDA. Filers submitting 

entries via the Automated Broker Interface (ABI) to 

Customs for cargo release are required to provide FDA 

information on entries subject to its jurisdiction submitted 

through ACE. The means of receiving notification for nonABI entries can be arranged through local Customs/FDA 

division agreements.

6.2.3.6.1 - U.S. CUSTOMS AND BORDER 

PROTECTION 

CBP's ACE uses guides established by each Federal 

agency to identify which commodities are subject to their 

jurisdiction. These guides are known as Other Government 

Agency (OGA) flags. FDA flags are identified as FD1, FD2, 

FD3 and FD4. 

For entries flagged FD1 the commodity may or may not be 

subject to FDA regulation. Electronic entries for the filer 

may, based on information received from the importer 

regarding the intended use of the commodity, specify the 

entry is not subject to FDA regulation and "Disclaim" the 

entry. Otherwise, FDA required information must be 

submitted. FDA review of "Disclaimed" entries is performed 

periodically to confirm the accuracy of the declaration. 

Entries covered by an FD2 flag must include FDA required 

information. 

FD3 indicates that the article may be subject to prior notice 

under section 801 (m) of the FD&C Act and 21 CFR Part 1, 

subpart I, subpart I, e.g. the article has both food and nonfood uses. The filer may, based on information received 

from the importer regarding the intended use of the 

commodity, specify the entry is not subject to prior notice 

and “Disclaim” the entry. If the product is an FDA regulated 

product, but not a food, the entry can be disclaimed from 

prior notice by using the affirmation of compliance code 

“PND” in the entry. 

FD4 indicates that the article is “food” for which prior notice 

is required under section 801(m) of the FD&C Act and 21 

CFR Part 1, subpart 1. Entries covered by FD4 flag must 

include prior notice required information.

Electronic entries for CBP review include all mandatory 

CBP entry required information, i.e., entry number, entry 

date, importer identification, port of entry, vessel/voyage 

information, filer identification, Harmonized Tariff System 

(HTS) code for product description, information on foreign 

shipper, country of origin, etc. Through the screening 

process in ACE, CBP determines if the article is subject to 

FDA examination (see OGA flag identifications above).

6.2.3.6.2 - FDA 

In collaboration with the U.S. Customs and Border 

Protection (CBP) and 46 partner government agencies, 

the Food and Drug Administration has been working to 

modernize business processes through the 

implementation of the Automated Commercial 

Environment/International Trade Data System 

(ACE/ITDS). ACE/ITDS is a single access point whereby 

industry can electronically submit all data required by 

various government agencies involved in international 

trade. ACE replaced the Automated Commercial System 

(ACE) in 2016. 

FDA has established Intended Use Codes (IUC) to assist 

FDA reviewers in determining the end use of the imported 

product. Some commodities require the use of IUC, some 

commodities have optional IUC, and IUC are not applicable 

for some commodities.
CHAPTER 6 INVESTIGATIONS OPERATIONS MANUAL 2023 

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Affirmation of Compliance (A of C) codes provide FDA 

reviewers with information concerning the imported article. 

They are also used by filers to affirm that the firm and/or 

product identified in an FDA line meets the requirements 

specific to the product being imported. A of C code 

requirements are dependent on the commodity being 

imported and can be impacted by the IUC.

To review the specifications and requirements for filing in 

ACE as per the final rule, refer to 81 FR 85854 

Submission of Food and Drug Administration Import Data 

in the Automated Commercial Environment, and the 

FDA’s Supplemental Guide for the Automated Commercial 

Environment/International Trade Data System (ACE/ITDS) 

Version 2.5. 

OASIS generates a "Notice of FDA Action" providing 

information on the actions taken regarding a particular entry 

line e.g. “Notice of Sampling”, “Release Notice”, “Notice of 

Detention and Hearing”, and “Notice of Refusal of 

Admission” The Notice identifies the specific line(s) of the 

entry, where appropriate, with the description of the sample 

collected or intended for sampling, specific line(s) identified 

as detained, and/or the specific line(s) identified as 

released, refused, etc. As the status changes for any line, 

a new "Notice of FDA Action" is issued to advise the 

appropriate individuals of the changes. The use of the 

designation "Product Collected by FDA," "Detained," 

"Released," "Refused," etc., or similar wording on the 

"Notice of FDA Action," meet the requirements of the 

wording of the law and regulation when applied to "giving 

notice thereof to the owner or consignee." See Exhibit 6-1.

Notices are designed to be electronically or physically 

distributed to the addressees. Those who hold an approved 

ITACS account may opt to receive Notices via email or as 

a download within ITACS. A copy of each Notice is 

produced with the filer, importer of record, and consignee

and delivered to the party on the addressee line. (If the 

same firm acts in one or more of those functions, only one 

copy is produced for the firm.) Notices are official 

documents which provide notification of a change in the 

status for an FDA regulated entry/line. The distribution of 

the Notices is made by FDA, not the filer, to ensure proper 

notification to the parties involved (i.e., FAX, express pickup services, postal service, etc.). The intention is for FDA 

to distribute to the responsible firm without an intermediary.

6.2.3.7 – VQIP Entry Processing 

FDA will work with CBP to expedite entry into the United 

States for VQIP foods. FDA sets screening in its Predictive 

Risk-based Evaluation for Dynamic Import Compliance 

Targeting (PREDICT) import screening system to 

recognize shipments of food which are the subject of an 

approved VQIP application. The system is designed to 

recognize the information and release the shipment 

immediately after the receipt of entry information, unless 

examination and/or sampling are necessary for public 

health reasons. FDA will limit examination and/or sampling 

of VQIP food entries to “for cause” situations (i.e., when the 

food is or may be associated with a risk to the public health), 

to obtain statistically necessary risk-based microbiological 

samples, and to audit VQIP. 

6.2.4 - SAMPLING 

6.2.4.1 - Ports Covered by FDA 

For electronic entry submissions, if the filer receives a 

message indicating FDA review, the filer will provide 

appropriate entry information to the FDA office having 

jurisdiction over the port of entry. The filer can also submit 

the entry documents electronically to FDA via the Import 

Trade Auxiliary Communications System (ITACS).For 

those entries submitted by paper, all appropriate entry 

documents should be included with the package sent to the 

local FDA office.

After evaluating the entry, if FDA decides to collect a 

sample, the appropriate individuals/firms will be provided 

with a Notice for Sampling and advised:

1. If the entry is to be held intact for FDA examination or 

sampling;

2. Only those designated items need be held; etc.

6.2.4.2 - Ports not Covered by FDA 

For those ports where CBP does not maintain its ACE 

electronic entry process, and FDA does not generally cover 

the port under its normal operating schedule, the 

responsible FDA district office will coordinate coverage with 

the responsible CBP Port manager to assure FDA 

notification. If FDA decides to examine or sample articles 

being entered through such a port, CBP, the importer, and 

broker will be notified.

Generally, for these entries, examination and/or sampling 

can take place at the point of destination. Under certain 

conditions, however, FDA may ask CBP to collect a sample 

at the point of entry for forwarding to the FDA servicing 

laboratory. Appropriate information on the entry, sample 

requirement, and requirements for holding the entry will be 

provided to the CBP officials and importer by the 

responsible district.

6.2.4.3 - Entry Sampling 

If no examination or sample is requested, FDA will notify

CBP and the filer (who is responsible for notifying the 

importer, or other designated parties). This electronic 

notification is called a "May Proceed Notice". It indicates 

the shipment may proceed without further FDA 

examination. This may occur as a result of the initial FDA

import systems screening or after the division performs an 

"On-Screen-Review". 

NOTE: Since the article is allowed entry without FDA 

examination, should the article, at a later time, be found in 

violation of the law, the Agency is not prevented from taking 

legal action because the article was allowed admission by 
INVESTIGATIONS OPERATIONS MANUAL 2023 CHAPTER 6

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FDA without examination at the time of importation. (See 

section 304(d) of the FD&C Act [21 USC 334(d)]

If an examination or sample is requested, FDA notifies 

CBP, broker or filer, importer, or other designated parties. 

Notification is either through the electronic entry system or 

other form of notification (Notice of FDA Action), to hold the 

entry and will identify the specific product(s) to be sampled, 

etc.

6.2.4.4 - Notice of Sampling 

When a sample is collected by FDA, a Notice of FDA Action 

is issued to the importer of record, consignee, and filer. If 

CBP collects the sample for FDA, the division will enter the 

entry information into FDA Import systems and issue the 

Notice of FDA Action.

For those entries where specific lines (items) of an entry are 

not sampled or examined, the Notice of FDA Action will be 

amended to indicate which lines (items) have been issued 

a "May Proceed." (See RPM Chapter 9-19"Notice of 

Sampling" for detailed guidance.)

6.2.4.5 - Payment for Samples 

The FDA will pay for all physical samples collected by FDA 

and found to be in compliance (See 21 CFR 1.91). In 

addition, FDA will pay for physical samples collected by 

FDA as an audit of private laboratory analytical results 

submitted to FDA when the FDA audit sample is found to 

be in compliance. (NOTE: FDA does not pay for samples 

found to be non-compliant (violative) or for samples taken 

in connection with the supervision of a reconditioning.) See 

IOM 4.2.8.2 for guidance on sample costs.

Billing for reimbursement should be made to the FDA 

district office in whose territory the shipment was offered for 

import. FDA will not pay for a sample if the article is initially

found to be in violation, even though it is subsequently 

released. For this reason, do not pay for samples at the time 

of collection.

Samples taken in connection with the supervision of a 

reconditioning are not paid for by FDA.

6.2.5 - PROCEDURE WHEN PRODUCTS 

CANNOT BE SAMPLED OR EXAMINED 

If the entry is still under control of the district inspection 

operations, and the sample collection cannot be completed, 

the district may annotate the notice to the filer and importer 

no product was collected and return the entry to the filer

designating the entry "May Proceed." If the designated 

product was part of a multi-line entry where other products 

were collected, the notice issued for the other items 

sampled will be appropriately updated with the release of 

the product not sampled.

In the OASIS system, when a notice is issued for the 

collection or examination of a product, and neither 

operation is accomplished, the filer will be advised through 

a revised Notice indicating the article is given a "May 

Proceed" status. The system will print a status of "May 

Proceed" in the Line Summary and also print a detail 

section "Lines Which May Proceed."

In OASIS, the following are definitions used to describe 

"May Proceed" or "Release" actions:

May Proceed: "Product may proceed without FDA 

examination. FDA has made no determination the product 

complies with all provisions of the Food, Drug, and 

Cosmetic Act, or other related acts. This message does not 

preclude action should the products later be found 

violative." (No compliance decision has been made.)

Release: "The product is released after FDA examination. 

This message does not constitute assurance the product 

complies with all provisions of the Food, Drug and Cosmetic 

Act, or other related Acts, and does not preclude action 

should the product later be found violative." (A compliance 

decision has been made.)

Districts will follow the appropriate guidance under each of 

the above procedures, according to their import operations.

6.2.6 - PROCEDURE WHEN NO 

VIOLATION IS FOUND 

If the shipment is found in compliance after examination, 

the importer of record, consignee (where applicable), filer, 

and CBP are notified with a Notice of Release. The 

shipment may be admitted. (See RPM Chapter 9-5

“Release Notices" for detailed guidance).

6.2.7 - PROCEDURE WHEN VIOLATION IS 

FOUND 

6.2.7.1 - "Notice of Detention & Hearing" 

If examination of the sample or other evidence indicates the 

article appears to be in violation, and detention is the 

course of action chosen by the district, the filer, owner and 

consignee, where applicable, are advised of such action by 

"Notice of Detention and Hearing." The Notice will specify 

the nature of the violation charged and designate a site for 

the owner or consignee (or authorized representative) to 

appear at a hearing. These hearings are informal meetings 

with the district, designed to provide the respondents an 

opportunity to present evidence supporting admissibility of 

the article. Ordinarily the respondents are allowed 10 

working days to appear. However, if for some compelling 

reason the district determines ten (10) working days are 

insufficient; this time period may be extended. On the 

OASIS generated "Notice of FDA Action", this date is 

identified under the caption "Respond By". A copy of this 

Notice is also sent to CBP. (See RPM Chapter 9-10 

“Response (Hearing) to Notice of FDA Action – Detained.) 
CHAPTER 6 INVESTIGATIONS OPERATIONS MANUAL 2023 

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6.2.7.2 - Response to "Notice of Detention 

& Hearing" 

Response to the Notice of Detention and Hearing may be 

made personally, by representative or by mail. The importer 

may present evidence supporting the admissibility of the 

article, request refusal of admission, propose an effective 

manner of reconditioning, or a method to remove the 

product from the authority of the FD&C Act.

6.2.7.3 - Request for Authorization to 

Relabel or Recondition Non-compliant 

Articles 

FDA may authorize relabeling or other remedial action upon 

the timely submission of an "Application for Authorization to 

Relabel or To Recondition Non-Compliant Articles," (Form

FDA 766 - See Exhibit 6-2). This form is also available in 

fillable formats online at 

http://www.fda.gov/media/71537/download. 

Application may also be made by letter and the execution 

of a good and sufficient bond by the owner or consignee 

(See section 801(b) of the FD&C Act [21 U.S.C. 381(b)]). 

The redelivery bond on file with the Port Director of CBP for 

the particular importation applies to any relabeling or other 

action authorized, a new bond will not have to be filed.

After review of the application, FDA will notify the importer 

of its approval or disapproval. If approved the original 

application will be returned outlining the conditions to be 

fulfilled and the time limit within which to fulfill them will be 

noted. Notification to other parties will be made where 

appropriate. A copy will be retained in the district files. (See 

RPM Chapter 9, subchapter 9-10 "Response (Hearing) to 

Notice of FDA Action - Detained", and subchapter 9-12, 

"Reconditioning" for detailed guidance).

6.2.7.4 - Inspection after Approved 

Reconditioning has been Completed 

After the relabeling or reconditioning operation has been 

completed, the applicant will submit the "Importer's 

Certificate" (page 2 of Form FDA 766, Exhibit 6-2) or advise 

the district that reconditioning is complete. At this point, 

FDA may conduct a follow-up inspection and/or sampling 

to determine compliance with the terms of the approved 

reconditioning application, or it may accept the statement 

from the importer with no further follow-up. The follow-up 

inspection and/or sampling may be made by FDA or CBP, 

depending on agreements between the division and local

CBP. The "Report of Investigator/Inspector" (section 4, 

page 2 of Form FDA 766, Exhibit 6-2), or other 

appropriately completed summary of reconditioning, should 

be forwarded to the appropriate FDA office.

6.2.7.5 - Procedure when Conditions of 

the Approved Reconditioning Application 

Have Been Fulfilled 

If the conditions of the approved reconditioning application 

have been fulfilled, the district will notify the owner or 

consignee by Notice of Release. This notice is usually 

identified as "Released after reconditioning." A copy is also 

sent to CBP and the filer. Where there is a non-admissible 

portion (rejects), they must be destroyed or re-exported 

under FDA or CBP supervision. A Notice of Refusal of 

Admission should be issued for the rejected portion. FDA 

may include in its approval of the reconditioning a provision 

for the non-admissible portions (rejects) of the 

reconditioning to be destroyed and not exported.

6.2.7.6 - Procedure when Conditions of 

the Approved Reconditioning Application 

Have Not Been Fulfilled 

If the initial attempt at reconditioning is unsuccessful, a 

second attempt should not be considered unless a revised 

method of reconditioning shows reasonable assurance of 

success.

If the conditions of the approved reconditioning application 

have not been fulfilled, a "Notice of Refusal of Admission" 

is issued to the importer, consignee (where applicable) to 

the filer, and to CBP. 

6.2.7.7 - Procedure after Hearing - "Notice 

of Release"

If, after presentation of testimony, the division determines 

the article should be released, the importer of record and 

consignee are issued a "Notice of Release". The Notice will 

declare the detained goods may be admitted. The Notice 

will also be identified "Originally Detained and Now 

Released" and, where appropriate, explain the reason for 

the change of action. A copy of the Notice is sent to CBP, 

and all parties receiving the Notice of Sampling/Notice of 

Detention. (See RPM Chapter 9-7 "Release Notices" for 

detailed guidance.)

6.2.7.8 - Procedure after Hearing - 

"Refusal of Admission" 

When the importer requests the district issue a “Notice of 

Refusal of Admission”, or the district decides the shipment 

still appears to be in violation, the importer, owner, and 

consignee where applicable, are issued a "Notice of 

Refusal of Admission". On this Notice, the charge(s) is 

stated exactly as shown on the original (or amended) 

“Notice of Detention and Hearing”. A copy of the Notice is 

also sent to CBP. (See RPM Chapter 9-11"Notice of 

Refusal of Admission" for detailed guidance.)
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The “Notice of Refusal” provides for the exportation or 

destruction of the shipment, under CBP supervision, within 

90 days of the date of the notice, or within such additional 

time as specified by CBP Regulation. Under OASIS, the 

Notice will also contain language which includes reference

to the requirement for redelivery and contain all the above 

required information concerning the product and charge(s). 

The FDA file remains open until the district receives 

notification indicating the goods were either destroyed or 

exported.

FDA is responsible for the protection of the U.S. public 

regarding foods, drugs, cosmetics, tobacco products, etc. 

until the violative article is either destroyed or exported.

6.2.7.9 - Payment of Costs of Supervision 

of Relabeling and/or Other Action

After completion of the authorized relabeling or other 

action, FDA will submit a detailed statement of expenses 

incurred, including travel, per diem or subsistence, and 

supervisory charges, on a Form FDA 790 (See IOM Exhibit 

6-3, Charges for Supervision). This is completed by FDA

employees regarding the supervision of the authorized 

relabeling or other action to U.S. Customs and Border 

Protection – Revenue Division. The expenses shall be 

computed on the following basis:

1. Supervising Officer’s time

2. Analyst's time

3. Per diem allowance

4. Travel other than by auto - actual cost of such travel

5. Travel by auto (mileage, toll fees, etc.)

6. Administrative support

Future enhancements to FDA import system may result in 

electronic processing of the supervisory charges submitted 

to CBP, in which case the Form FDA 790 will no longer be 

used. (See RPM Chapter 9-13"Supervisory Charges" for 

detailed guidance.)

CBP, upon receipt of the charges for supervision, will send 

a notice for payment to the identified importer of record. The 

expenses shall include charges for supervision of 

destruction of the article or rejects. The remittance by the 

owner or consignee shall be to CBP. Payment of 

supervisory charges should not be accepted by FDA district 

offices.

6.2.7.10 - Exportation of Goods Refused 

Admission 

Exportation of refused goods is done under CBP

supervision. However, if after a reasonable time, FDA has 

not received notification of exportation or destruction, the 

district should investigate the status of disposition. Districts 

should also consider, under certain conditions, verifying the 

refused goods have been held intact pending exportation 

or destruction, or that re-export actually occurred. Guidance 

on refusals to be verified may change, based on the reason 

for detention. Each District involved in performing Import 

Operations has been assigned a set number of import 

exams of refused entries as part of ORA’s Performance 

Goals. 

6.2.7.11 - Bond Action 

Under the provisions of the FD&C Act (section 801(b) of the 

FD&C Act [21 U.S.C. 381(b)]) and CBP regulations (19 

CFR 113.62) a bond is required for all conditionally 

released articles offered for importation. This bond provides 

relief to the government on the default of the conditions of 

the bond and the payment of liquidated damages in the 

amount specified in CBP notice of assessment of liquidated 

damages for failure to redeliver such goods. 

Bond actions are taken when an entry is distributed prior to 

FDA release and cannot be redelivered, or when an article 

has been detained and refused and the article is not 

destroyed or exported in accordance with the requirements 

of the law.

If district has evidence the entry, or any portion of an entry 

subject to FDA jurisdiction, was disposed of in violation of 

the terms of the appropriate Act, or its regulations, or of the 

terms of the bond, (see 19 CFR Section 113.62 (l)(1)) they 

should immediately contact the appropriate Customs office.

The district, upon receiving evidence the refused article 

was not exported or destroyed should immediately 

investigate the matter. See Section 6.1.3 of the IOM, 

Investigations Involving the Import Process. Send a 

detailed statement showing the importer's liability under the 

redelivery bond or other applicable customs bond to the 

responsible CBP office. If the facts warrant, and the article 

was under detention, and the Notice of Refusal of 

Admission has not been issued, immediately issue a Notice 

of Refusal to the owner or consignee, with a copy to CBP. 

Upon the receipt of an application for relief (appeal for 

Mitigation or Cancellation of Assessed Liquidated 

Damages), CBP may agree to mitigate the amount of 

damages. However, in cases involving FDA goods, CBP

does not usually mitigate unless FDA is in full agreement 

with the action [see 21 CFR section 1.97 (b)]. (See RPM 

Chapter 9-12 "Bond Actions" for detailed guidance.)

6.2.8 – PHOTOGRAPHS: IDENTIFICATION 

AND STORAGE 

Photographs are evidence documented during import field 

work and are a crucial element in case development. They 

should be clear and capture evidence needed to support 

the appearance of a violation and the proposed charges. 

The photographs should capture, at a minimum, all sides 

of the product packaging, labeling, (i.e. top, bottom, and 

sides; including blank sides), all labeling (e.g. package 

inserts and any labeling that provides the intended use of 

the product, product value, directions for use, daily intake, 

and firm information) any available production (lot) codes 

and/or dates, an overall view of the lot(s) examined, and 

any adverse conditions observed. 
CHAPTER 6 INVESTIGATIONS OPERATIONS MANUAL 2023 

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Photographs must be collected and uploaded 

electronically to the entry/line via FDA import systems 

(ER, OASIS, SERIO) for all sample collections, Class 2 

and Class 3 field/label exams, detention requests (when 

warranted), destructions, reconditioning, refusal 

verification discrepancies, and other situations as 

warranted. 

All photographic evidence (including photographs of 

labeling) must be identified with the following required 

information: entry/line number, collection date, 

investigator’s initials, a brief description of the photo, and 

must be numbered in a manner that allows future 

reviewers to determine if any pages or photos are missing 

(e.g., 123-456789-1/11/1; 8/10/20; RS, information panel, 

right side, 1 of 4).

Photographs may be uploaded directly from a government 

issued mobile device or computer file to an entry/line via 

FDA import systems. The system records the date/time 

and investigators initials at the time of upload. The 

required information described above must be included 

within the file name and/or using the Document Remarks 

section (See SERIO manual instructions) specific to each 

photograph during the document upload process. 

However, there is no need to include the entry/line number 

when uploading from a mobile device or computer file as 

the photograph(s) will be directly associated to the 

entry/line. For example, the file name or Document 

Remarks would include “information panel/right side, 1 of 

4”.

Photographs may also be downloaded and combined into 

a single document (e.g., Word or PDF document) for each 

entry/ line with the required information included within the 

document. 

If photographic evidence is printed, it should be 

documented in one’s regulatory notes and the required 

information must be permanently affixed to the printed 

photos so that there is never any loss of association 

between the photographic evidence and the entry/line. 

This information must be recorded immediately above or 

below the photograph(s) (not directly on the photos) so 

that the integrity of the evidence is not compromised.

Note: If additional enforcement or legal actions including 

but not limited to seizure, injunction, debarment or 

prosecution are contemplated with respect to an import 

case, the procedures for preparing and maintaining digital 

photographs and video as evidence, as described in IOM 

5.3.4.2.5 and IOM 5.3.8.3, must be followed.

SUBCHAPTER 6.3 – ENTRY REVIEW 

6.3.1 - GENERAL 

Entry review consists of the examination of any electronic 

data and/or hard-copy entry documentation received by 

FDA for an FDA regulated entry line. The information 

received is reviewed to determine if entry admissibility 

criteria for the commodity are met, and if additional actions, 

such as examination sampling, or detention request, are 

applicable and/or necessary. 

An investigator may be assigned the role of an import entry 

reviewer. Entry reviewers use sound judgment based on 

their experience and training when performing entry review. 

All import entry reviewers receive both formal training and 

on-the-job training to ensure they are familiar with 

admissibility requirements and can effectively use FDA 

databases. Along with attending national import courses, 

on-the-job training should result in the ability to conduct 

entry review independently with minimal supervision.

An entry reviewer is expected to possess the knowledge to:

• Utilize the electronic Imports Entry Review (ER) 

system.

• Access and reference appropriate FDA databases.

• Reference initial admissibility job aids and other 

FDA work instructions to ensure accurate and 

consistent entry processing.

• Use the internet to access and review regulatory 

requirements not included in an FDA database 

(e.g. the Interstate Certified Shellfish Shippers 

List).

• Make the appropriate initial admissibility entry 

decision (e.g. “May Proceed”, request field work, 

recommend detention) and provide 

remarks/justification as appropriate.

• Understand ORA Field Work Plan and Sample 

Collection Operation Planning Effort (SCOPE) 

obligations to assure that center-prioritized work is 

completed.

• Refer entries to OCI and Partner Government 

Agencies (PGA) when warranted.

• Refer entries to a supervisor and/or Compliance 

Branch (CB) when information is uncovered during 

ER that may require a national screening criteria 

recommendation by CB.

The entry reviewer takes one of three final entry review 

actions: 

1. “May Proceed”,

2. Detention Request (DER/DTR), or 

3. Request Field Examination (FEX), Label 

Examination (LEX), and/or Sample Collection 

(SAM). 

Entry review actions can be supported by: 

1. Electronic and/or hard-copy entry documentation 

including declarations of intended use

2. Electronic systems screening of entry information 

3. Affirmations of Compliance (AofC) such as 

Registration and Listing. 

4. Database Query 

5. Import Alerts (IA)/Import Bulletins (IB)

6. Past compliance history 

7. Compliance Program Guidance Manuals (CPGM) 

8. Import Assignments, DIO Field Advisories and 

Notices, and SCOPE

9. Intelligence from PGAs

10. Management directives 
INVESTIGATIONS OPERATIONS MANUAL 2023 CHAPTER 6

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NOTE:

The Automated Commercial Environment (ACE) requires 

filers to submit certain data elements for FDA regulated 

products. For specific ACE requirements, refer to the most 

current FDA Supplemental Guide. If inaccuracies are found 

with the transmitted manufacturer, shipper, product code, 

or country data elements that could affect entry screening, 

correct the information, assign fault, save, and rescreen the 

entry/line 

• If information exists to support the appearance 

of a violation or if compliance with the 

regulations cannot be confirmed (e.g., 

Registration, Listing, Approval), forward a 

Detention Request to the Compliance Branch.

• The reviewer may, at any time, assign or set up 

a work request for examination or sample 

collection (e.g. LEX, FEX, or SAM). 

See Regulatory Procedure Manual (RPM) Chapter 9 and 

Initial Admissibility Job Aids for additional information 

concerning the review/processing of entries of specific 

types of commodities, including products under detention 

without physical examination. 

Entry review activity is reported as Import Investigation 

Time in OASIS.

6.3.2 – INITIAL ENTRY REVIEW 

Lines submitted electronically to FDA are received with 

the initial work types of Quantity and Value (QAV) or No 

Quantity and Value (NQV). In addition to receiving 

electronic entries, FDA receives non-ABI (paper) entries. 

For non-ABI entries, follow the same decision-making 

criteria as electronic entry filing, but electronically 

transmitted entries will be given review priority. NOTE: If 

setting up work on a non-ABI entry, refer to the Entry 

Review Job Aid for specific instructions on creating a 

manual entry in ER.

 

Use the actual arrival date/time (for truck ports of entry) 

and submission date/time (for air, rail and sea ports of 

entry) when prioritizing entry review lines. In general:

• Lines with a QAV work type take priority over lines 

with an NQV work type. 

• Lines with documents sent via Import Trade 

Auxiliary Communications System (ITACS) take 

priority over lines with documents sent via 

alternative means of transmission. 

The quantity and value for each line are typically provided 

electronically for FDA review to aid in the admissibility 

process. Quantity and value are required to setup a work 

request. 

6.3.2.1 –Emergency and Perishable 

Shipments 

Emergency or perishable shipments take priority over nonperishable shipments.

An emergency shipment consists of one or more lines that 

require immediate review based on a demonstrated and 

urgent need or situation. Emergency entries are to be 

handled per import division discretion to control and 

prevent abuse by regulated industry and individuals. 

Perishable products are articles not otherwise preserved 

in a manner so as to prevent the quality, safety and/or 

effectiveness of the article from being adversely affected if 

held for an extended period of time under normal shipping 

and storage conditions. Perishable products are raw and 

fresh products stored in ambient or refrigerated conditions. 

These products typically consist of raw/fresh seafood, 

raw/fresh produce (fruits and vegetables), and 

temperature and/or time sensitive drugs, vaccinations, lab 

reagents, or biologics. 

Device shipments may be released if the entry documents 

include documentation verifying approval by CDRH. If 

unable to verify the authenticity of the approved 

document, please contact the center at 

cdrhimport@fda.hha.gov.

6.3.2.2 – Reviewing Entry Data and 

Information 

Electronically submitted entry lines that are not issued a 

“May Proceed” by the system are manually reviewed by 

entry reviewers.

Review of entry lines submitted electronically is conducted 

using the ER system. ER incorporates PREDICT 

(Predictive Risk-based Evaluation for Dynamic Import 

Compliance Targeting), a screening tool that uses 

automated data mining, pattern discovery, and automated 

queries of FDA databases to determine the potential risk 

of a shipment. It takes into consideration the inherent risk 

of certain commodities and information about the previous 

history of importers, manufacturers, and shippers. Those 

lines with the highest risk are flagged for additional review. 

ER system recommendations should be reviewed and 

considered before taking any action. For specific 

instructions on navigating through and using ER, refer to 

the Entry Review Job Aid.

When an entry reviewer issues a “May Proceed” for a line 

flagged for an IA that is indicated as Priority Review, 

record a remark in the Priority Review “Remarks” field that 

provides a clear justification as to why the line is not 

subject to detention without physical examination (DWPE). 

NOTE: The firm taking a corrective action is not a 

sufficient reason to issue a “May Proceed” for the line. If 

the firm has taken corrective action, they should request to 

be removed from the IA, and the request will be reviewed 

by the appropriate center and DIO. The following are 

some examples of acceptable remarks:

• “The product brand submitted for entry is not a 

brand name subject to DWPE.”

• “Product is in powdered rather than liquid form.”

• “Specific manufacturer and/or product is exempt 

from IA XX-XX”

• “Documentation shows imported item does not 

contain heparin”
CHAPTER 6 INVESTIGATIONS OPERATIONS MANUAL 2023 

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The Admissibility requirements that need to be verified 

when performing entry review for electronic and non-ABI 

(paper) entries are depended upon the commodity being 

offered for import (e.g. food, medical, devices, drugs, 

radiological health products, cosmetics, biologics, and 

tobacco products). Commodity specific requirements are 

outlined in the Initial Admissibility Job Aids.

The following are some activities performed by entry 

reviewers prior to making an initial entry admissibility 

decision:

• Review the commodity-based PREDICT 

cumulative percentile rank and mashup in ER 

which shows the risk score. Request the most 

recent copy of the PREDICT Guide for Rules and 

Scoring

• Review all entry line flags in ER. For example:

o If you observe an IA flag in ER, determine 

if the firm and/or product combination is 

subject to DWPE

o If you suspect that the firm/product should 

have an IA flag in ER but is not flagged, 

conduct follow-up investigative work to 

determine if the firm and/or product 

combination is subject to DWPE.

o Report problems and provide feedback 

using the ER feedback functionality when 

a PREDICT rule does not fire or fires in 

error. For additional instructions on this 

functionality, refer to the Entry Review 

Job Aid.

• Perform firm/product searches on applicable 

center databases. Review entry documents when 

necessary.

• Request field work that aligns with the ORA Field 

Work Plan, SCOPE, obligations, and center 

assignments.

• Use applicable guidance and instructional 

documents to determine compliance with 

regulatory requirements.

• Refer any non-FDA regulated product transmitted 

to FDA to the agency which has authority over 

that product. For example:

o If you receive an entry of Siluriformes fish 

(includes catfish, tra, swai and basa) and 

fish products, contact the broker and 

inform them that as of April 2016, 

Silurifomes fish and fish products should 

no longer be transmitted to FDA.

 Request broker to cancel and 

refile the entry.

 Fill out and submit the 

Siluriformes FSIS Referral Form. 

 Request Import Systems Branch 

to remove the entry/line from FDA 

Import Systems after broker 

confirms entry cancellation.

The following is a list of resources that an entry reviewer 

should be familiar with when performing entry review 

functions:

• Commodity-Specific Resources, which provide 

center-specific Import resources that include links 

to additional information (e.g. center contact 

information and case routing, initial admissibility 

resources, field and label examination work 

instructions and additional resources).

• FDA Affirmations of Compliance (AofC) for the 

Automated Commercial Environment, which 

provides definitions of required AofCs for articles 

offered for entry.

• Compliance Program Guidance Manuals which 

provide instructions to assist FDA personnel in 

evaluating compliance with the FD&C Act and 

other laws administered by FDA.

• Internal documents such as the ORA Field Work 

Plan, SCOPE, active import assignments, internal 

notices, advisories, bulletins, and Standard 

Operating Procedures (SOP).

• RPM Chapter 9 “Import Operations and Actions”.

• PREDICT Guide for Rules and Scoring

• Agreements and Memoranda of Understanding 

(MOU) which define lines of authority or 

responsibility, and or clarify cooperative 

procedures (See 3.1.2.1).

6.3.2.2.1 – Manual “May Proceed”

If compliance with regulatory requirements can be 

confirmed using information transmitted electronically 

and/or information provided in entry documents, and there 

is no indication that a detention recommendation or 

request for field work is appropriate, the entry reviewer 

should issue a “May Proceed” for the entry line.

NOTE: No further manual verification of AofC data is 

needed if the line passes the automated database lookup.

6.3.2.2.2 – Rescinding a “May Proceed” 

or IB Release 

Rescinding a ”May Proceed” or “IB Release should” only 

occur for articles that are subject to a compliance action or 

in exceptional cases and must be accomplished 

immediately. This action should not be used for routine or 

work plan examination or sampling purposes.

When an entry receives a “May Proceed” or IB Release, 

the conditional release period of the entry ends (Section 

6.3.4) and does not re-open when the “May Proceed” or IB 

Release is rescinded.

If an entry line inadvertently receives a “May Proceed” or 

IB Release or additional information is received that 

warrants further review for admissibility:

• Obtain supervisory approval prior to rescinding 

the “May Proceed” or “IB Release”. 
INVESTIGATIONS OPERATIONS MANUAL 2023 CHAPTER 6

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• Notify the filer immediately that the FDA “May 

Proceed” or “IB Release” has been rescinded and 

the line is pending an FDA Admissibility decision.

• Generate an updated Notice of FDA Action and 

forward it to the filer, importer of record, and 

consignee within 24 hours of rescinding the “May 

Proceed” or “IB Release

• Send a request to CBP within 24 hours of 

rescinding the “May Proceed” or “IB Release” to 

Unset/Hold the CBP Bond from liquidating in case 

Compliance Branch needs to pursue a liquidated 

damages case against the bond for cargo FDA 

refused and not redelivered for export or 

destruction.

• ABI codes to indicate “PGA Decision RescindedDo Not Distribute Product” and “May Proceed 

Rescinded-Hold for Further Information From 

PGA” or “Release Rescinded-Hold for Further 

Information From PGA” are sent to the filer.

• If the shipment has been distributed, notify CBP 

and request that they issue a demand for 

redelivery. (See IOM 6.2.3.2 for information 

regarding informal entries.) CBP has 30 days to 

demand redelivery from the date the conditional 

release period ended (i.e. the “May Proceed” was 

issued.) Any delays compromise FDA’s ability to 

request CBP issue a Notice to Redeliver.

• This process and communication with CBP shall 

be recorded in the Entry Remarks and/or 

Miscellaneous Info Received field to document 

FDA follow-up when FDA issues a “May Proceed” 

or “IB Release” inadvertently. 

6.3.2.2.3 – Recommend Detention 

(DER/DTR) 

The detention recommendation process is described in 

IOM section 6.3.5 – Detention Recommendations by Entry 

Reviewers. 

6.3.2.2.4 – Request Examination and/or 

Sampling (LEX/FEX/SAM) 

When requesting field work, the entry reviewer should:

• Update transmitted data in line details if 

inaccuracies are found that would affect an 

admissibility decision or would result in inaccurate 

information being populated on a Notice of FDA 

Action. Record reason for update, save, and 

rescreen the data.

• Set the entry up for examination and/or sample 

collection by choosing the correct work 

type/Problem Area Flag (PAF) combination. Work 

should be set up in accordance with agency 

priorities, work plans, SCOPE, and assignments.

• Enter instructions in the “Instruction Text” field for 

the investigator to reference when work is set up 

for any reason other than routine surveillance. 

Instructions might be necessary, for example, 

when:

o ORA Assignments may require specific 

remarks;

o Specifying if exam instructions should be 

used during the examination (e.g. “further 

instructions, follow DOPG-Device-05 for 

Glucose Meters and Glucose Strips, Field 

Examinations.”);

o A specific discrepancy is found during the 

entry review process that should be 

evaluated during the examination and/or 

sampling;

o Referencing the results of previous 

violative examinations/samples (include 

the previous entry/sample numbers for 

reference);

o Indicated in an Import Bulletin;

o Special notes are applicable (e.g. any 

known safety precautions, or specifics 

about the product itself).

NOTES:

• Do not routinely set up work on a line that is 

confirmed to be subject to an IA. However, there 

could be special situations when a line subject to 

IA may need to be examined for a reason 

unrelated to the IA. In these situations, work may 

be set up under a PAF that is not related to the IA.

• The Entry Review Job Aid includes specific 

instructions on updating and re-screening 

electronic data, setting up work, and entering work 

instructions in the “Instruction Text” field.

6.3.2.2.5 – Notices 

When the entry reviewer recommends detention or 

requests field work, the filer is notified through ABI 

(Automated Broker Interface) and a Notice of FDA Action 

generated in OASIS. Notices of FDA Action are to be 

distributed as described in IOM 6.2.3.6.2. – FDA.

6.3.2.2.6 – Cancelled Entries 

Entry reviewers should be able to identify CBP cancelled 

entries in ER. Entries that have been cancelled by CBP 

will display static text at the top of multiple creens 

indicating “This Entry is Cancelled”. The Entry Review 

Grab Bag (ERGB) will display a “Y” in the “Cncld” column 

and the Current Entry Status field will display “ACS/ACE 

Entry Cancelled”. 

6.3.2.2.7 - Partner/Other Government 

Agency (OGA) Referral 

The purpose of OGI (Other Government Agency - 

Investigations Branch) and OGC (Other Government

Agency – Compliance Branch) work types are to close a 

line without an admissibility decision being recorded by 

FDA. Selecting OGI/OGA from Possible Actions allows 

Investigations Branch (IB) to close a line with no further 
CHAPTER 6 INVESTIGATIONS OPERATIONS MANUAL 2023 

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action after OGA referral from the OGA Entry Review 

Grab Bag. Selecting OGC/OGA from Possible Actions will 

route the line to Compliance Branch (CB) and allow CB to 

close the line with no further action after OGA referral from 

the OGA Compliance Grab Bag.

Note: In some areas, OGAs are referred to as PGAs 

(Partnering Government Agencies). 

One situation IB may use OGA referral to close a line 

without an FDA admissibility decision is when an entry has 

been refused or seized by another government agency 

(i.e., APHIS or CBP) and FDA did not have the opportunity 

to examine the entry. Therefore, FDA does not have 

adequate information to make an initial entry admissibility 

decision. The line(s) within the entry may be closed with 

no further FDA action after referral to an OGA has been 

recorded. When this occurs, documentation showing 

evidence of the final disposition of the product should be 

obtained and uploaded to the entry/line prior to closure 

with OGA referral. 

An Ad-Hoc OGA referral, found under the Action menu, 

allows the field to record an OGA referral but does not 

allow closure of the line with no further action after OGA 

referral. Ad-Hoc OGA Referrals differ from the use of 

OGI/OGC work types in that they are used strictly to 

provide information to the OGA without deferring FDA’s 

responsibility to make an admissibility decision. If an AdHoc OGA referral is recorded the line will still need to be 

processed with an entry admissibility decision. 

Regardless of whether FDA did or did not have the 

opportunity to examine the goods but has adequate 

information to make an initial entry admissibility decision, 

the entry should be processed according to established 

procedure. This includes May Proceed or detention 

recommendation (DTR or DER). The OGA referral can 

still be recorded using an Ad-Hoc OGA Referral if 

needed.

If an entry has been acted on by an OGA and the entry 

has been cancelled by CBP, the entry will be automatically 

closed by the system if no work has been assigned. If 

work has been assigned, the field can send a request to 

close the cancelled entry to the ORA OISM DSS ISB 

Import Systems Problem Reports group at 

ORAOISMDSSISBImportSysProblemRpts@fda.hhs.gov

. 

If there is a need to refer a line to an OGA that is not 

found in the system, please contact the Division DIALs

who will then work with DSS to have the OGA added.

6.3.3 – ENTRY DOCUMENTATION

The admissibility of an article may depend on the 

submission of entry documentation, which may include the 

following: Bill of Lading (BOL) or Airway Bill (AWB), invoice, 

purchase order, certificates of analysis, copies of labeling, 

intended use statement, or other related documentation.

The 3461 and 7501 have been eliminated for electronic 

transmission of entries in ACE. Reviewers should not be 

holding up admissibility of lines to review these documents. 

They are still used for Non-ABI or paper entries.

6.3.3.1 – Request of Entry Documents 

(DRQ) 

If during the initial review of an entry, the reviewer 

determines that additional information is necessary to make 

an admissibility decision, request documents via the 

“Documents Required” Entry Option (DRQ). In the 

“Remarks” field of the “Issue Entry Option” page enter: 

• The reason the documents were requested to 

assist in the future review of the entry or line.

o NOTE: Do not routinely request 

documents solely for the purpose of 

verifying the accuracy of submitted data.

• A summary of the data elements reviewed and 

admissibility requirements needed for review. 

This information will expedite review of the documents 

once they are received and will avoid a duplication of 

efforts. For example:

The DRQ entry option sends an electronic message to the 

filer via the FDA-CBP Interface, but does NOT generate a 

Notice of FDA Action.

6.3.3.2 – Receipt of Entry Documents 

Entry documents may be submitted to FDA in several ways. 

Documents received via ITACS, are given priority over 

documents received via other means. Documents can be 

submitted prior to or at the time of a DRQ. 

If documents are not received, refer to Section 6.3.3.4 

Failure to Submit Entry Documents and Follow-up 

Requests. 

6.3.3.2.1 – Uploading documents received 

outside of ITACS 

When work has been set up on an entry and documents 

have subsequently been received from the filer or importer 

outside of ITACS (e.g. email, mail, fax), upload the 

documents using ER. Instructions for uploading 

documents can be found in the Entry Review Job Aid. 

Examples of documents that should be uploaded by the 

entry reviewer include:

• Product labeling
INVESTIGATIONS OPERATIONS MANUAL 2023 CHAPTER 6

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• Email correspondence that contains information 

that might affect admissibility

• Entry documentation such as invoices, packing 

slips, FDA forms, or CBP forms

NOTES: Electronically viewed material such as web 

pages can also be uploaded via ER. Ensure that for all 

records, the record retention policy is adhered to.

6.3.3.3 – Review of Entry Documents 

When documents are received, review entries in 

chronological order (e.g. by earliest submission date in 

Imports Entry Review, by email receipt date). Documents 

received via ITACS are given priority over documents 

received via other means. 

If, after review of the entry documents, sufficient information 

exists to support the appearance of a violation or if 

compliance with the regulations cannot be confirmed (e.g., 

Registration, Listing, Approval), forward a Detention 

Request to the Compliance Branch (See IOM 6.3.5). 

If examination or sample collection is indicated, assign or 

set up a work request (e.g., LEX, FEX, or SAM).

If the documents submitted do not provide sufficient 

information to make an entry admissibility decision, the 

reviewer may follow-up by using: 

• Direct communication (i.e. email, phone call) with 

the filer or importer 

• Entry Incomplete – Return, Deficient Entry (DEF) 

Entry Option 

• Request Information (INF) Activity

In the follow-up communication, indicate to the importer/filer 

the specific additional information needed, and that if the 

information is not provided, FDA may take other action to 

continue the admissibility review. 

Record direct communications with the filer or importer in 

the “Remarks” field of the Entry Details page or via the “Log 

Miscellaneous information received” (MIB) function. Include 

the date, method of communication (i.e. email, phone), 

content requested, point of contact and reviewer name or 

initials in the remarks. 

Please note that neither the DEF Entry Option nor the INF 

Activity sends an electronic message to the filer via the 

FDA-CBP interface, however, they do generate a Notice of 

FDA Action. Specify the information requested in the 

“Narrative” field of the DEF Entry Option and the 

“Information Requested” field of the INF Activity. In addition, 

if the INF Activity is used, it will display as a status in ITACS, 

advising the user to view the narrative for details via the 

Notice of FDA Action. 

NOTE: Information entered in the “Remarks” field is for 

internal use only. Information entered in the “Narrative” field 

appears in the Notice of FDA action.

6.3.3.4 – Failure to Submit Entry 

Documents and Follow-up Requests 

If entry documents are not received within three business 

days after requesting documents via the DRQ entry option 

(under 6.3.3.1), the system will automatically send an 

electronic message to the filer stating, ‘Second and Final 

Request for Information’ (DR2). This automated message 

does not generate a Notice of FDA Action. Documents 

received outside of ITACS must be uploaded into 

ER/OASIS to prevent the DR2 message.

In addition, the reviewer can also send a follow-up request 

to the filer. The reviewer may follow-up by using any of the 

following options available: 

• Direct communication (i.e. email, phone call) with 

the filer or importer 

• Deficient Entry (DEF) Option or

• Request Information (INF) Activity

In the follow-up request to the filer/importer, indicate the 

specific additional information needed, and that if additional 

information is not received, FDA will continue its 

admissibility review without the benefit of the additional 

information. 

Record direct communications with the filer or importer in 

the “Remarks” field of the Entry Details page or via the “MIB 

function”. Include the date, method of communication (i.e. 

email, phone), content requested, and reviewer name or 

initials.

If additional information is received after follow-up 

communication, proceed to making an entry decision

unless additional follow-up is warranted. 

If the requested information is not received, take 

appropriate action (e.g. setup field work or request 

detention). If detention is requested, refer to IOM 6.3.5. 

6.3.4 – ENTRY DECISION

Under the conditions of the entry bond, articles may receive 

a conditional release by CBP pending a final admissibility 

decision by FDA. An FDA entry decision must be made 

prior to the end of the conditional release period (within 30 

calendar days after CBP has conditionally released the 

product), unless otherwise extended. If FDA does not take 

an action to extend the conditional release period, it will 

terminate upon the earliest occurring of the following 

events:

• The date that FDA issues a notice of refusal of 

admission;

• The date that FDA issues a notice that the 

merchandise may proceed;

• Upon the end of the 30-day period following the 

date of release.

As indicated in 19 CFR 141.113(c), to extend the 

conditional release period, FDA must issue a written or 

electronic notice (within 30 days of the conditional release 
CHAPTER 6 INVESTIGATIONS OPERATIONS MANUAL 2023 

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of the merchandise), informing the bond principal (i.e., 

importer of record) that the product will be examined, 

sampled or has been detained. The DRQ, DTR, DER, DEF 

and INF functions do not extend the conditional release 

period.

6.3.5 - DETENTION RECOMMENDATIONS 

BY ENTRY REVIEWERS 

Importers introduce goods through multiple ports of entry 

and work with a variety of districts. FDA personnel review 

these import entries utilizing data submitted by 

filers/brokers to make an initial admissibility decision. FDA 

regulated products which appear to be non-compliant 

and/or subject to an Import Alert or Import Bulletin should 

be considered for field work or submission to the 

Compliance Branch (CB) with a detention 

recommendation. Since filers have interactions with 

multiple FDA districts, it is vital that entries be handled by 

a uniform procedure regardless of the port of entry.

6.3.5.1 - Submission of Detention 

Recommendations to the Compliance 

Branch at the Entry Review Step 

Entry reviewers recommend detention using one of two 

work types: DER or DTR.

1. DER refers to a detention recommendation based 

on Detention without Physical Examination 

(DWPE), and is utilized when a product is subject 

to DWPE and is either listed on an Import Alert 

(IA) or meets the criteria found in Direct 

Reference Authority for DWPE (6.3.5.4.2.1, 

below). 

2. DTR refers to all other detention 

recommendations for products with the 

appearance of a violation, either because 

administrative requirements cannot be verified or 

other evidence supports the appearance of a 

violation. 

NOTE: If additional entry documentation is needed to 

support the detention recommendation, collect prior to 

submitting a recommendation. Include comments for all 

detention recommendations articulating the reason why 

the entry is being sent to the CB for review.

6.3.5.2 - General Procedures Pertaining to 

all Detention Recommendations (DER 

and DTR) 

Entry Reviewers ensure detention recommendations are 

aligned with center specific requirements. To promote 

consistency across districts, refer to the Center Specific 

Initial Admissibility Job Aids for instructions on commodityspecific requirements and center database use. The entry 

reviewer is responsible for searching all applicable center 

databases prior to a detention recommendation. Ensure 

research conducted in the FDA database systems is 

documented in the remarks section of the detention 

recommendation.

Prior to submitting a detention recommendation, verify 

accuracy for all Line Details in the entry. 

1. If at any time data is found to be incorrect, correct 

the inaccuracies. NOTE: Quantity and Value are 

required to take a “Next Step” and for CB to take 

action.

2. Split lines if necessary.

3. Rescreen updated lines.

a. If data has been changed, click on “Save”, 

then enter a brief description in the popup box, and assign fault to any errors as 

appropriate.

NOTE: Some firms or products may be subject to multiple 

import alerts or compliance with multiple regulations 

cannot be verified at the time of entry. In these situations, 

the entry reviewer should recommend detention for all 

applicable import alerts and/or problem area flags (PAFs).

6.3.5.2.1 - Entry Documents 

Entry documents are not required for all detention 

recommendations made by an entry reviewer, as indicated 

below in sections 6.3.5.3, 6.3.5.4, and 6.3.5.5. However, 

the CO does require entry documents for case review. For 

detention recommendations made by the entry reviewer 

without having the entry documents, the entry documents 

should be requested for CO use per the instructions 

below.

1. If entry documents were not obtained prior to 

making the detention recommendation (DER or 

DTR), ensure the “Entry Option” selected in the 

drop-down menu includes a document request, 

e.g. “Hold Designated, Others Go, Docs 

Required”. This designation alerts the filer to 

submit entry documents to FDA. 

2. Entry documents received by the investigations 

branch outside of ITACS are to be uploaded via 

FDA import systems (ER, SERIO).

a. JA-000038 - Job Aid for the Entry Review 

Application contains instructions for 

uploading entry documents via ER. 

b. OASIS Mail/Baggage Procedures contains 

instructions for attaching entry documents via 

OASIS.

c. MAN-000091 - System for Entry Review and 

Import Operations (SERIO) User Manual 

contains instructions for uploading documents 

via SERIO.

6.3.5.3 - DER - Import Alert (IA)

A Detention without Exam Recommendation or DER is 

utilized in Entry Review for entries/lines that are subject to 

an Import Alert (IA).

Entry documents and additional evidence are not required 

prior to submission to the CB if all the following 

requirements are met:

• The elements in the electronic submission match 

the criteria found in the IA (e.g. Country of Origin 
INVESTIGATIONS OPERATIONS MANUAL 2023 CHAPTER 6

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(“CofO”), declared manufacturer, product 

description).

• The IA does not specify that entry documents be 

submitted 

• No additional information is necessary to make an 

initial admissibility decision 

• No additional line information is required 

NOTE: Request entry documents and/or additional 

evidence prior to a DER submission when the IA specifies 

that the shipment may be detained if it is not accompanied 

by certain additional entry documents and/or evidence. 

Example: IA 28-02 for Indian Black Pepper states that 

Districts may detain all shipments of black pepper from 

India not accompanied by a certificate, containing certain 

information, from the Indian EIC. 

When submitting a DER:

1. Ensure that you follow the instructions for each 

applicable IA (more than one IA may apply to a line). 

a. Verify electronic entry information matches the IA 

prior to submitting the DER to CB. This includes: 

• CofO 

• Firm Name and Address (for the 

manufacturer, shipper, consignee, or importer, 

as applicable to the import alert) 

• Importer Description/Product Description 

(Some IAs are very general - ensure the 

specific product is subject to the IA) 

2. Update and rescreen as appropriate. 

3. Enter the following comments in the “Instruction Text” 

field located in the “Work Details” section of the “Work 

Request and Work Request Details” screen: 

a. Example: “Manufacturer/Product is subject to IA 

XX-XX” or “CofO/Product combination is subject 

to IA XX-XX” 

b. If required by the IA, ensure that any research 

conducted in the FDA database systems are 

documented in the remarks section. Example: 

“Per IA XX-XX (Database Name) was reviewed 

and (Manf/Supplier) was issued a W/L”. 

4. If it is suspected that an entry/line may be subject to 

an IA but cannot be confirmed from the electronic 

entry data, request and/or review entry documents. 

This may occur when a manufacturer name is listed 

on an IA, but the address differs from what was 

electronically transmitted.

a. If the entry documents show that the electronic 

information submitted was incorrect, update and 

rescreen the entry/line. If the updated entry/line is 

subject to an IA follow the DER procedures 

above.

b. If review of the entry documents show that the 

entry/lines are not subject to the IA, the reviewer 

can determine the appropriate next step (MPro, 

FEX/LEX, SAM, DTR). 

6.3.5.4 - DTR 

A Detention Recommendation (DTR) is utilized at the 

entry review step when the reviewer cannot confirm that 

products being offered for import meet FDA’s admissibility 

criteria. Prior to recommending a DTR, the reviewer may 

utilize the electronic submission, internal FDA databases, 

and any entry documentation submitted by the filer to 

make a determination. A field/label exam or sample 

collection may be assigned to aid in determining 

admissibility. 

6.3.5.4.1 - Similar to Import Alert 

If the product appears to be similar to a 

product/manufacturer/CofO combination on IA and 

additional information is needed to determine if the 

product is subject to IA:

1. Request and review the entry documents.

2. Update and rescreen inaccurate data.

3. If the entry is subject to IA, follow procedures for DER 

(See IOM Section 6.3.5.3).

4. If the product does not match the IA, determine the 

next step, which could include any of the following: 

a. May Proceed

If the entry flagged for the IA, and is subsequently 

released:

• Provide feedback to the Import Compliance 

Systems Branch (ICSB) using ER if the line 

flagged incorrectly for an IA. (PREDICT 

Guide: Rules and Scoring) 

• Include a comment as to why the product was 

not subject to the IA. Example: “Firm flagged 

for IA XX-XX but product is not subject to IA 

(include reason why product is not subject to 

IA)”.

b. Request Field Work (SAM/FEX/LEX): 

• Include pertinent instructions in the 

“Instruction Text” field located in the “Work 

Details” section of the “Work Request and 

Work Request Details” screen. Example: 

“Firm/product may be subject to IA XX-XX, 

collect pertinent evidence (labeling, 

photographs, entry documents, sample)”.

c. If a violation (different from the IA) has been 

determined, submit a DTR to CB.

• Include pertinent comments in the “Instruction 

Text” field located in the “Work Details” 

section of the “Work Request and Work 

Request Details” screen. Example: “No 

(Listing) found in (database searched) for 

(manf/product)”.

6.3.5.4.2 - Previous Violative Results 

(pending IA addition)

At times the Entry Reviewer may come across 

entries/lines that contain the same product and 

manufacturer as a previous entry/line that was found 

violative and is pending addition to Import Alert. 

Depending on the screening criteria and whether or not 

ORA has direct reference will impact the reviewer’s next 

step.

NOTE: In these situations, a screening criteria may have 

been implemented by the CO to ensure reviewers are 

aware of the violative findings.
CHAPTER 6 INVESTIGATIONS OPERATIONS MANUAL 2023 

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6.3.5.4.2.1 Direct Reference Authority for 

DWPE

When ORA has direct reference authority (DIO Advisory 

#1) and the electronic entry is an exact match to the 

previously found violative shipment, additional entry 

documents and/or evidence may not be necessary. 

NOTE: Ensure any additional requirements included 

within an assignment are met.

When you encounter one of these shipments and ORA 

has direct reference authority: 

a. Recommend Detention (DER). 

b. Include pertinent comments in the “Instruction Text” 

field located in the “Work Details” section of the “Work 

Request and Work Request Details” screen:

a. Previous violative findings, CMS/work activity 

number and/or entry number, Reference to the IA, 

any evidence collected. Example: “Previous 

violative findings (issue found, CMS/work activity 

number and/or entry number) firm/product 

awaiting addition to IA XX-XX. Direct reference 

authority for (product) for addition to DWPE. No 

physical exam conducted.” 

6.3.5.4.2.2 - No Direct Reference Authority 

for DWPE 

When ORA does not have direct reference authority, the 

entry must stand on its own. There are many factors to 

consider in these types of situations such as risk and 

pending cases. Discuss the next steps with your 

supervisor and CB. Possible next steps could include the 

following:

1. Request and/or review entry documents.

2. Request Field Work (SAM/FEX/LEX)

a. Include pertinent instructions in the “Instruction 

Text” field located in the “Work Details” section of 

the “Work Request and Work Request Details” 

screen. This includes: Previous findings, 

CMS/work activity number and/or entry number, 

instruction for field work. Example: “Previous 

violative findings (issue found and entry number) 

firm/product awaiting addition to IA XX-XX. 

Review labeling for ephedrine alkaloids.”

3. If a violation is determined for the current shipment, 

submit to CB under the applicable Problem Area Flag 

(PAF).

4. May Proceed the entry if no violation is found with the 

current shipment.

6.3.5.5 - Registration/Listing/Approval

Some products may require registration, listing, and/or 

approval. The steps below describe how to recommend 

detention when compliance with these requirements 

cannot be verified.

Registration and Listing

1. When registration and/or listing is required, review the 

electronic submission. For those entries where 

compliance cannot be confirmed using the electronic 

data transmitted and internal FDA databases, request 

and review entry documentation.

2. Recommend detention (DTR) if the necessary 

registration or listing cannot be verified after reviewing 

the entry documents and the appropriate center 

database. 

NOTE: Failure to submit Affirmation of Compliance 

data or a look-up failure is not sufficient to recommend 

detention. Prior to recommending detention, make a 

reasonable effort to verify compliance with registration 

and listing requirements in the center databases using 

the manufacturer and product information provided.

a. Include pertinent comments in the “Instruction 

Text” field located in the “Work Details” section of 

the “Work Request and Work Request Details” 

screen. Such as, the database reviewed, 

findings, any evidence collected.

Example: “No registration or listing found in 

(database) for manufacturing company (Provide 

specifics as to what does not match (i.e. name, 

street address, city))”.

3. If additional information is not submitted in the 

electronic or paper entry and is required to make an 

initial admissibility decision (e.g. drop ball test or can 

size), request that specific information from the filer.

Approval

1. When the required approval cannot be verified after 

reviewing the entry documents and searching the 

appropriate database, collecting additional product 

labeling is not required to recommend detention, unless 

specifically noted by additional guidance. If the entry 

reviewer is unable to determine if the product requires 

approval, collect the product labeling. Legible copies or 

photos of the labeling from the current shipment should 

accompany the detention recommendation. 

a. Reference the pertinent Initial Admissibility Job 

Aids for center requirements, e.g., intended use, 

end use, and annual reports (IOM Section 

6.3.5.2).

b. Include pertinent comments in the “Instruction 

Text” field located in the “Work Details” section of 

the “Work Request and Work Request Details” 

screen. Such as the database reviewed, findings, 

and any evidence collected.

Example: “No (approval e.g. NDA, ANDA, 510(k), 

PMA, etc.) found in (database) for 

manufacturing/product combination. Labeling, end 

use letter, and intended use included in 

submission.” 

6.3.5.6 - IFE

Follow current procedures for reviewing IFE (Import for 

Export) entries (IOM 6.2.3.4 and RPM 9-15).

SUBCHAPTER 6.4 - FIELD EXAMINATION 

6.4.1 - GENERAL 

A field examination is a physical inspection of products 

subject to FDA jurisdiction. Examinations may take place at 

the port of entry, warehouse, cold storage facility, or other 
INVESTIGATIONS OPERATIONS MANUAL 2023 CHAPTER 6

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designated examination site. Additional information about 

performing field examinations, specific to product and 

program area, may be addressed in the Compliance 

Program Guidance Manuals (CPGMs) and the Compliance 

Policy Guides (CPGs)

A field examination involves actual physical examination of 

the product for such things as: 

1. Confirming that product and quantity present 

corresponds to product and quantity declared on 

shipping documents, 

2. In transit or storage damage, 

3. Inadequate storage temperature conditions,

4. Rodent, bird or insect activity,

5. Lead in ceramic ware (Quick Color Test – QCT and 

Rapid Abrasion Test - RAT), 

6. Odors uncharacteristic for the product or of spoilage,

7. Non-permitted food and/or color additives, and 

8. General label compliance (label examinations) 

A label examination (LEX) is used when the investigations 

branch conducts a label review (LBL) of the physical 

product in the field to determine labeling compliance. The 

remarks entered and exam class selected can be used by 

compliance to make an admissibility decision for the 

product. A Label exam should be recorded as LEX. All 

other field examinations should be recorded as a FEX 

along with the appropriate problem area flag (PAF)

When conducting a field examination, compare 

documents provided by the filer/importer, to what is 

physically available during your inspection and to the 

information that was electronically submitted. Record your 

observations in your regulatory notebook at the time of the 

field exam. Information to record includes:

• Date

• Entry number

• Name and address of the location where the 

exam is taking place

• Name and title of the persons providing 

information about the entry/lot being 

examined

• Information from the product labeling 

including the name of the product and any lot 

numbers or codes identified

• Number of units examined

• Documentation of any photos or labels 

collected

• Any abnormalities or discrepancies observed

• A record of the quantity of any product that 

was destroyed in the field as part of the field 

examination process, if any 

Note: Additional instructions on regulatory notes 

can be found in IOM Subchapter 2.1 

REGULATORY NOTES.

A field examination does not have the same level of 

confidence as a laboratory examination. Consequently, 

more rigorous standards of acceptance are applied than 

those used for formal regulatory levels. For example, if the 

formal action guideline for whole insects is 10 per 100 gm 

in product X, you may sample product X when your field 

examination shows only one or two insects per 100 gm. The 

decision to sample is, to some degree, left to your 

discretion. In most instances, it should be based on findings 

significantly lower than specified by the formal guideline.

See IOM 5.1.4.3 for suggestions on what to do when 

conducting a field examination when the firm responsible 

for the products invites individuals who are not directly 

employed by the firm to observe the examination. See IOM 

6.4.10 for instructions on recording field/label examination 

results in OASIS.

6.4.2 - FIELD EXAMINATION SCHEDULE 

A field examination should include a physical examination

of a minimum of five containers (cases, cans, bags, etc.) 

of a product, or as directed by Compliance Programs,

specific product examination schedules (e.g., LACF), or 

other guidance. All containers opened for exam should be 

identified with FDA, division abbreviation, the date of the 

examination, and the lead investigator’s initials.

When you conduct any field examination, in addition to 

specific items discussed in the following sections, be alert 

for any over labeling where a product name or identity 

may have been changed; different manufacturer than that 

transmitted or provided in the entry documents; product 

without mandatory English labeling; changes in expiration 

date or lot numbers; product quantity differences; product 

integrity; country of origin (under CBP authority 19 CFR 

134) or similar questionable practices. If you encounter 

any of these items, document your findings and discuss 

the appropriate action with your Supervisor. 

6.4.3 - FIELD AND LABEL 

EXAMINATIONS – FOODS AND 

COSMETICS 

See IOM 5.4.1.4.2 for information on performing 

reconciliation examinations during import field 

examinations.

6.4.3.1 - Food Sanitation

Microbiological - field examinations cannot be used for 

suspected microbiological contamination.

Filth and Foreign Objects - field examine only those 

product/container combinations in which you can physically 

view and examine the product, e.g., products which can be 

probed, products in see-through containers, etc. See 5.1.5,

for additional instructions on performing field examinations.

Canned and Acidified Foods – See IOM Chapter 4

SAMPLE SCHEDULE CHART 2.
CHAPTER 6 INVESTIGATIONS OPERATIONS MANUAL 2023 

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Decomposition in Non-sealed Foods - This can include 

organoleptic examination for fish, seafood, frozen eggs, 

etc.

6.4.3.2 - Pesticides, Industrial Chemicals, 

Aflatoxins, & Toxic Elements

Field examinations cannot be performed for most 

pesticides, chemical contaminants, natural toxins and 

metals, except for metals in dinnerware and the side seam 

solders of cans.

NOTE: Divisions should use commercial versions of the 

Quick Color Test (QCT) and the Rapid Abrasion Test for 

lead, e.g. Lead Check Swabs, while conducting field 

examination of dinnerware and food cans to determine if 

follow-up sampling is required. The testing scheme for 

dinnerware can be found in CP 7304.019. Specific 

information regarding the techniques of testing dinnerware 

and can side seam solder can be found in Lab Information 

Bulletins (LIB) 4127and LIB 4041, respectively on the Office 

of Regulatory Science (ORS) intranet site. 

6.4.3.3 - Food and Color Additives 

Perform a visual examination of the container and a label 

review for the mandatory labeling requirements. Determine

if a color additive is declared for a product to which it

appears coloring has been added. Determineif a declared

color additive is acceptable for use in the product. 

The use of a color additive must conform with the 

requirements stated in the color additive’s listing regulation. 

These requirements are outlined in the “Color Additive 

Status List” and the “Summary of Color Additives Listed for 

Use in the United States in Food, Drugs, Cosmetics, and 

Medical Devices.” These lists provide the current status and 

use limitations of color additives permitted in food, drug, 

cosmetic, and medical device products.

Requirements for declaring color additives on food labels 

are provided in 21 CFR 101.22 (k) Color additives subject 

to certification may be declared by the names listed in 21 

CFR parts 74 and 82 or by abbreviated names that omit 

“FD&C” and “No.” The term “Lake” must be included in the 

names of color additive lakes. FD&C Yellow No. 5 is 

specifically required to be declared on food labels under 21 

CFR 101.22 (k) and 21 CFR 74.705. Cochineal extract and 

carmine are specifically required to be declared on food 

labels under 21 CFR 101.22(k) and 21 CFR 73.100. 

Othercolor additives not subject to certification may be 

declared by the names listed in 21 CFR part 73 or in general 

terms such as “Artificial Color,” “Artificial Color Added,” or 

“Color Added.”

Determine if a preservative declaration includes its 

purpose; for example, "Sodium Benzoate as a 

preservative."

6.4.3.4 – Nutrition Labeling and Food 

Allergen Labeling 

The only valid field examination which can be performed 

for this type of problem is a label examination for the 

mandatory labeling requirements. Refer to the "Industry 

Resources on the Changes to the Nutrition

Facts Label” and Food Allergen Labeling and Consumer 

Protection Act of 2004 (FALCPA) requirements for 

guidance. 

Note that there are requirements for voluntary Gluten-Free 

label claims. Such claims must meet the requirements in 

the Gluten-Free labeling of foods regulation (21 CFR 

101.91). This is an important public health issue for 

persons suffering from Celiac disease. For products that 

bear gluten-free claims, refer to “Gluten- Free Labeling of 

Foods” page for guidance.

Also see the “Food Labeling & Nutrition” website for the 

most up-to-date information regarding claims in labeling. 

Also, see CP 7321.005 to determine areas as emphasis for 

food labeling violations.

6.4.3.5 - Food Economics (On Consumer 

Size Containers only) 

Label Examination - Review labels for all aspects of the 

labeling requirements.

Net weight - See IOM 4.3.7.1

Food Standards - The only valid field examination which 

can be performed for Food Standards is a label 

examination for the mandatory labeling requirements of a 

particular Food Standard.

6.4.3.6 - Cosmetics 

Valid cosmetic field examinations include a reconciliation 

examination for security purposes and/or a label 

examination for the mandatory labeling requirements. The 

most important labeling considerations are:

1. Ingredient Labeling (21 CFR 701.3)

2. Prohibited ingredients (21 CFR 700.11 through 700.27 

and 21 CFR 250.250)

3. Non-permitted color additives (see Color Additives 

Status Lists)

4. Warning Statements (21 CFR 740.11, 740.12, 740.17, 

and 740.19)

5. Cautionary/Other Required Statements (for example, 

required caution statement and directions for patch test for 

coal-tar hair dyes - FD&C Act sec. 601(a); required 

caution statement for the color additive lead acetate - 21 

CFR 73.2396; required label information for the color 

additive bismuth citrate – 21 CFR 73.2110; and required 

label information for the color additive henna – 21 CFR 

73.2190)
INVESTIGATIONS OPERATIONS MANUAL 2023 CHAPTER 6

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6. Tamper Resistant Packaging Requirements (21 CFR 

700.25) 

7. Other Labeling Requirements (21 CFR 701.10 through 

701.13)

For further questions contact the Office of Cosmetics and 

Colors. 

6.4.4 - FIELD AND LABEL EXAMINATION 

– DRUGS 

A field examination involves actual physical examination 

of the product (minimum of five containers or as directed 

by Compliance Programs).

• Confirm that product and quantity present 

corresponds to product and quantity declared on 

shipping documents.

• Examine security and integrity of the container 

including tamper resistant packaging requirements. 

• Examine for in-transit or storage damage or 

inadequate storage temperature conditions.

• Examine for any over labeling where a product name 

or identity may have been changed.

• Examine if the manufacturer is the same as the one 

transmitted or provided in the entry documents.

A label exam involves an examination of the product label 

and accompanying labeling. The drug products must 

comply with the general labeling requirements found in 21. 

CFR 201.1 – 201.328. Product labeling should bear all 

required information in English. If product labeling includes 

a language other than English, it should contain all 

required information in both languages. Exception: Labels 

in Spanish for distribution in the Commonwealth of Puerto 

Rico is authorized under 201.15 (c). For bulk drugs verify 

that product labeling complies with the requirement(s) in 

21 CFR 201.122. Section 201.125 does not apply to bulk 

drugs only to finished dosage prescription drug products.

6.4.4.1 - Labeling 

Bulk drugs and finished dosage forms should be evaluated 

for compliance with the drug listing and drug establishment 

registration requirements. 

6.4.4.2 - Contamination 

Drugs should be examined for container integrity, e.g., 

cracked vials, ampoules, bottles, etc.

6.4.4.3 - Samples 

A decision to collect samples should be made in 

accordance with relevant CPs and any applicable 

assignments. Samples collected from lots where the drug 

substance or finished product has been subjected to actual 

or suspected contamination should be decided on a caseby-case basis.

6.4.4.4 - Special Instructions 

Field examinations may be performed on drug lots to obtain 

information to determine the new drug status of a given 

shipment. Divisions should contact the CDER Office of 

Compliance, Office of Drug Security, Integrity and 

Response, Division of Imports Exports and Recalls, Import

Export Compliance Branch for guidance. 

6.4.5 - FIELD AND LABEL 

EXAMINATIONS – DEVICES 

Field and label examination instructions issued by CDRH

for specific devices are located on the Import Program

intranet site under commodity specific resources. 

At a minimum, the label should include the name and place 

of business of the manufacturer, packer or distributor and 

product identity. Be aware of mis declared devices, for 

example, TENS (transcutaneous electrical nerve 

stimulation) devices are often declared as therapeutic 

massagers but in fact should be declared as neurological 

therapeutic device. Products declared as destined for 

veterinary use only must include such a statement on the 

packaging and product. CAUTION: If the sealed packaging, 

such as an outer crate, of a medical device indicates that 

the manufacturer’s warranty will be violated should it be 

opened by someone other than a factory representative, 

DO NOT open the packaging. Consult with your supervisor 

regarding any further action. For further information refer to 

21 CFR Part 801. 

It is a common industry practice to manufacture and/or 

assemble, package, and fully label a device as sterile at 

one establishment and then ship such device in interstate 

commerce to another establishment or to a contract 

sterilizer for sterilization. During a field exam of “sterile 

“devices offered for entry, which are destined for 

sterilization, per 21 CFR 801.150, each pallet, carton, or 

other designated unit must be conspicuously marked to 

show its non-sterile nature when it is introduced into and 

moving in interstate commerce, and while it is being held 

prior to sterilization. 

FDA will not support import action against the device as 

misbranded or adulterated when the non-sterile device as 

labeled sterile if the lot is marked appropriately as noted 

previously. 21 CFR 801.150i also requires a written 

agreement between the foreign firm and the importer of 

record. Specifically, there is in effect a written agreement 

which: (i) Contains the names and post office addresses of 

the firms involved and is signed by the person authorizing 

such shipment and the operator or person in charge of the 

establishment receiving the devices for sterilization.(ii) 

Provides instructions for maintaining proper records or 

otherwise accounting for the number of units in each 

shipment to insure that the number of units shipped is the 

same as the number received and sterilized.(iii) 

Acknowledges that the device is nonsterile and is being 

shipped for further processing, and(iv) States in detail the 

sterilization process, the gaseous mixture or other media, 

the equipment, and the testing method or quality controls to 

be used by the contract sterilizer to assure that the device 
CHAPTER 6 INVESTIGATIONS OPERATIONS MANUAL 2023 

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will be brought into full compliance with the Federal Food, 

Drug, and Cosmetic Act. This should be verified upon 

import.

6.4.6 – FIELD AND LABEL

EXAMINATIONS - BIOLOGICS 

Review applicable import alerts regarding biologics prior to 

conducting any field examinations of biological products

subject to import alert. 

In general, products regulated by Center for Biologics 

Evaluation and Research (CBER) do not warrant a field 

examination, because they are licensed under Section 351 

of the PHS Act. In addition, lot release procedures 

pursuant to 21 CFR 610.2 apply to many products, such as 

vaccines.

If it is determined that a field examination is warranted for 

licensed or unlicensed CBER-regulated products, labeling 

for the product and its intended use should be examined.

Any questions should be sent to CBER Import Inquiry at 

CBERImportInquiry@fda.hhs.gov

6.4.7 - LABEL EXAMINATIONS - ANIMAL 

PRODUCTS 

Contact the CVM mailbox 

CVMImportRequests@fda.hhs.gov with questions on the 

importation of animal food, drugs, devices, and other 

animal products. You should be aware of various import 

alerts, Compliance Policy Guides or guidance documents 

as they affect individual import situations. See the 

commodity specific resources section in the Import 

Program intranet site for additional information or 

notifications on current import situations

6.4.7.1 – Animal Drugs 

Label examinations of animal drugs are visual 

examinations that are sometimes needed to determine 

product admissibility. A label examination may be 

necessary if:

• the product is an unapproved new animal drug, 

especially one for use in food animals;

• the product is sterile;

• the manufacturer is not registered with FDA or 

differs from the firm in the foreign drug 

manufacturer registration;

• the drug is not listed with CVM; or

• discrepancies between the information on the 

product label and the import documentation exist.

Bulk New Animal Drug substances and Active 

Pharmaceutical Ingredients (APIs) may be legally imported 

if the firm is registered with FDA and it is destined to the 

holder of an approved New Animal Drug Application

(NADA), Abbreviated New Animal Drug Application 

(ANADA), index listing or a Generic Investigational New 

Animal Drug Number (JINAD) or Investigational New 

Animal Drug Number (INAD) exemption. For bulk drugs for 

use in compounding for animals, confirm the registration 

and listing status of the firm and product and consult with 

the Center for the current status of the bulk drug substance 

presented for import. 

Type A Medicated Articles are animal drugs and must meet 

the appropriate drug requirements listed above.

FDA personnel may allow veterinarians and animal 

owners to import unapproved drugs under the 

Personal Importation Policy (PIP). For more 

information, refer to the Regulatory Procedures 

Manual, section 9-2 Coverage of Personal 

Importations.

6.4.7.2 – Animal Devices

Devices intended for animals do not require premarket 

approval. However, they are still subject to examination for 

adulteration and misbranding violations. When conducting 

your label exam, verify that labeling is not false or 

misleading and bears adequate instruction for use in each 

target animal group. When conducting your label exam, 

ensure the following:

• Devices for animal use are clearly marked for 

animal use only

• Prescription animal medical devices are labeled in 

the following manner: “Caution Federal law 

restricts this device to sale by or on the order of a 

licensed veterinarian.”

• Non-prescription animal medical device labeling 

bears adequate directions for use by the lay user.

In addition to being regulated by CVM, animal devices that 

are radiation emitting products are also regulated by 

CDRH. Import coverage for radiation emitting products is 

provided for in CPGM 7386.007 Imported Electronic 

Product. 

Animal devices that include a drug component should be 

referred to CVMImportRequests@fda.hhs.gov

6.4.7.3 - Animal Food 

Animal food and food components, including pet food 

should be examined for conformance with all applicable 

and appropriate food labeling requirements listed in 21 CFR 

501, be acceptable for animal food (e.g. not contain drug 

claims, be an approved food additive, generally recognized 

as safe (GRAS) for an intended use, or otherwise found 

acceptable as an animal food ingredient, and not contain 

hazardous levels of contaminants). For example, determine 
INVESTIGATIONS OPERATIONS MANUAL 2023 CHAPTER 6

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if a preservative declaration includes its function, such as 

“Sodium Propionate (preservative).”

A list of approved food additives for use in animal food is 

found in 21 CFR 573 and a partial list of GRAS substances 

for use in animal food is found in 21 CFR 582. Substances 

affirmed as GRAS for use in animal foods are listed under 

21 CFR 584. Irradiation is considered a food additive and 

approvals for the use of irradiation for animal food are found 

in 21 CFR 579. Additionally, animal food GRAS substances 

that have been notified to the FDA can be found in the 

Animal Food GRAS Notices Inventory. 

Ensure the use of a color additive conforms with the 

requirements stated in the color additive’s listing regulation. 

For further questions, contact 

CVMImportRequests@fda.hhs.gov. 

6.4.7.4 – Animal Grooming Aids 

FDA does not regulate products intended solely to cleanse 

or beautify animals, commonly referred to as grooming 

aids. Cosmetic regulations outlined in the FD&C Act do not 

apply to products intended for animal use. Products 

purporting to be animal grooming aids that are labeled as 

or otherwise intended for therapeutic purposes may be 

considered animal drugs. This may occur when a grooming 

aid is labeled to contain an active drug ingredient or to 

suggest or imply a therapeutic benefit. Refer to CPG Sec. 

653.100 Animal Grooming Aids.

NOTE: Medicated shampoos are not animal grooming aids 

and are regulated by FDA as animal drugs. Consult CVM 

before detaining these products.

6.4.7.5 – Animal Biological Products 

Although animal biological products are “drugs” within the 

meaning of the FD&C Act, animal drugs produced and 

distributed in full conformance with the Virus, Serum, Toxin 

Act (VSTA) and its implementing regulations administered 

by the United States Department of Agriculture Animal 

Health Inspection Service (USDA-APHIS) are not subject 

to the animal drug approval requirements in section 512 of 

the FD&C Act.

Under the regulations implementing the VSTA, 9 CFR part 

101, animal biological products are defined, in part, as “all 

viruses, serums, toxins (excluding substances that are 

selectively toxic to microorganisms, e.g., antibiotics), or 

analogous products at any stage of production, shipment, 

distribution, or sale which are intended for use in the 

treatment of animals and which act primarily through the 

direct stimulation, supplementation, enhancement, or 

modulation of the immune system or immune response.” 

(9CFR 101.2)

A MOU between APHIS and FDA (APHIS Agreement #04-

9100-0859-MU, FDA Serial #225-05-7000) addresses 

jurisdictional issues concerning the regulation of certain 

animal products as biological products. Examples of 

products listed in the MOU as products generally regulated 

as animal biological products by USDA-APHIS include 

vaccines, viruses, bacterins, bacterial extracts, allergens, 

antiserums, antitoxins, toxoids, immunomodulators, 

immunoglobulins, and serum and plasma for passive 

transfer. Examples of products listed in the MOU as 

products generally regulated as animal drugs by FDA 

include antibiotics, antimicrobial peptides, antiinflammatories, anthelmintic, antiprotozoal, competitive 

exclusion products, genetic constructs (non-vaccine), stem 

cell therapies, gene and somatic cell therapies, hormones, 

growth factors, growth promotants, whole blood, 

transfusions, and clotting products (except serum and 

plasma for passive immunity).

For questions regarding whether a product is regulated as 

a drug by FDA or an animal biological product by USDAAPHIS, contact CVMimportrequests@fda.hhs.gov. 

6.4.8 - FIELD AND LABEL 

EXAMINATIONS -RADIOLOGICAL 

HEALTH 

Guidance for inspection and field testing for radiationemitting electronic products is in CPGM 7386.001. Import 

coverage for radiation emitting products is provided for in 

CPGM 7386.007, Imported Electronic Product. 

When conducting fieldwork on radiation emitting products 

refer to the field and label examination work instructions 

issued by CDRH and located on the Import Program

intranet site under commodity specific resources. 

Additionally, field and label examinations for imported 

electronic products should include of entry documents and 

FDA-2877, Declaration for Imported Electronic Products 

Subject to Radiation Control Standards, to determine if 

they are properly completed and accurate. This applies to

each shipment of electronic products for which 

performance standards exist. Performance standards, 

covering ionizing, optical, microwave and radiation-emitting 

products, are specified in 21 CFR 1020 through 1040.

Inquiries pertaining to the radiological health program may 

be directed to RadHealth@fda.hhs.gov. 

6.4.9 - FIELD EXAMINATIONS – 

TOBACCO PRODUCTS 

Contact the Center for Tobacco Products (CTP) Office of 

Compliance and Enforcement, Division of Enforcement and 

Manufacturing, at CTP-ComplianceImports@fda.hhs.gov

with general questions on the importation of tobacco 

products. Label examination instructions issued by CTP are 

located on the Import Program intranet site under 

commodity specific resources. 

6.4.10 – FIELD/LABEL EXAMINATION 

RESULTS 

Examination results should be reported via FDA import 

systems for those lines that have been physically 
CHAPTER 6 INVESTIGATIONS OPERATIONS MANUAL 2023 

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examined. Results should reflect the findings within the 

limitations of an examination for the specified problem 

area. An examination should not be reported on lines that

were not physically examined. If adverse findings are 

encountered, examination work type(s) should be added 

to the line, if needed, to record the adverse findings under 

the appropriate problem area. 

Review the Line Details screen prior to completing the 

OASIS Field Exam Results Screen. 

1. Access the Line details by double clicking the work 

type field, i.e. “FEX”. This will open the “Entry/Line 

Summary” screen. Click the “Line Details” button.

2. Review all the data and verify that it is complete and 

correct. For example, make sure the product code 

matches the product, and that the manufacturer, 

country of origin, quantity and value are correct. Add 

any lot codes if applicable and update the Line 

Availability information if needed. If there is a build 

button on the line you need to correct, you must use 

the build function to make corrections. All fields that 

are white or highlighted in purple can be updated.

3. If data has been changed, click the “Save” button. 

Then enter a brief description in the pop-up box of 

corrections made. Assign fault to any errors as 

appropriate.

4. After any changes are made, save the changes and 

“Rescreen” the line to see if changing the data 

caused the line to hit on any other criteria or alerts.

Complete the examination results by navigating to Work 

Results:

The system auto fills the following fields: entry number, 

Lead Initials, Date Completed, Product Code, Product 

Description, Importer/Corrected Description, PAF, PAC, 

and Reference.

Enter data in the following fields:

6.4.10.1 – Date Completed 

The Date Completed field will default to the current date. If 

necessary, update the Date Completed field to the date 

the examination was completed. 

6.4.10.2 – Location of goods 

Enter the location where the examination was conducted if 

availability and location of goods have not been entered or 

if the exam location has changed. Include location name 

and address or resident post location.

6.4.10.3 – Remarks 

Enter the type of examination performed, describe how the 

examination was performed, and note any samples 

collected or photos taken, or product and quantity 

destroyed in the field as part of the examination process. If 

the examination was performed due to an assignment, 

import bulletin, or import alert, then enter pertinent 

information as instructed. 

Example Remarks text: “Conducted food filth exam under 

CP03819A. Viewed outer cases under a black light. 

Opened 5 of 10 cases and viewed contents through 

transparent packaging. Collected a sample for micro 

analysis under CP03819C.”

Or, “Exam was conducted according to DOPG-XXXX-XX. 

Examined 200 units and found 6 devices with integrity 

issues. A sample was collected for integrity analysis and 7 

photos documenting the exam were uploaded.”

Note – Text entered in the Remarks Field does not appear 

on the Notice of FDA Action. 

6.4.10.4 – Summary 

Enter the findings of the examination. Be as specific as 

possible in the allowed space. If the examination will be 

reported as Class 2 provide specific remarks detailing why 

Class 2 was chosen. 

Example Summary text: “All cartons are accounted for. 

No macro filth observed during examination. Exam Class 

2 as this line to be held for analysis of line 1/4.”

Or, 

“Observations include no ingredients statement, no 

serving size and incomplete nutrition info. Label 

submitted to CB for review.”

Note – Text entered in the Summary Field does not 

appear on the Notice of FDA Action. 

6.4.10.5 – Exam Class

Select the appropriate Exam Class.

Class 1 – No Adverse Findings within Problem Area: No 

adverse findings were noted within the limitations of the 

examination for the specified problem area. The entry 

line may be IB Released, sampled for a different 

problem area, referred to Compliance Branch for a 

different problem area or have additional work types 

added to it as appropriate. Additional action should not 

be taken within the specified problem area that was 

deemed Class 1

Class 2 – Other Findings: Class 2 is intended to be used 

only for those situations that do not meet the definitions 

of Class 1 or Class 3. Some examples of when to use 

Class 2 include the following (this list is not intended to 

be all-inclusive):

1. Potential adverse findings were observed. 

Observations lead to the collection of a sample 

or referral to compliance branch in the specified 

problem area for final admissibility 

determination. 

2. The product appears to be in violation within the 

limitations of a field examination for the 

specified problem area; however, investigations 

branch is using discretionary authority to 
INVESTIGATIONS OPERATIONS MANUAL 2023 CHAPTER 6

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release the product. If this option is used, 

describe in detail in the Summary field the 

reason(s) why this violative product is being 

released, such as, “This product meets the 

criteria for release under the Personal 

Importation Policy (PIP) as stated in the 

Regulatory Procedures Manual (RPM).” Note: 

The exemption for releasing a personal 

importation with a class 2 field exam findings, 

only applies to the mail environment.

3. No adverse findings were observed within the 

limitations of an examination for the specified 

problem area; however, the line is sampled 

within the same problem area due to the 

firm/product having a violative history in that 

problem area or as directed by an assignment, 

import bulletin or other guidance.

4. No adverse findings were noted within the 

limitations of an examination for the specified 

problem area; however, the line is being held 

and referred to compliance branch pending 

sample analysis of another line. (Note: it is 

inappropriate to record a field examination if no 

physical examination occurred. The “Same 

Action As” function allows for the holding of 

lines where no examination occurred pending 

the analytical results of another sampled line)

Class 3 – Adverse Findings within Problem Area: The 

product appears to be in violation within the limitations 

of an examination for the specified problem area. 

Further action must be taken under the specified 

problem area, i.e. sampled or referred to the compliance 

branch for final admissibility determination.

NOTE: If a LEX is conducted and the examination 

identifies labeling claims that may warrant marketing 

clearance and/or approval, record the findings as a Class 

3 LEX and submit to compliance as a DTR/AAP.

Click “OK” to save the examination results.

6.4.10.6 – Record Time 

Select the correct PAC from the drop-down menu. Enter 

your time. If more than one person worked on the 

examination, click on the “Add” button. A box will come 

up; select the person’s name from the drop down menu, 

and select the correct PAC from the drop down menu. 

Enter that person’s time. Repeat for each person who 

worked on the examination. Click “OK”. Note: time is 

entered in decimal format in tenths of an hour (6-minute 

increments). 

6.4.10.7 – Next Steps

Once the work has been submitted, if no other work was 

set up on the line, you will be prompted to Next Steps. 

If the exam was classified as Class 1 you will have the 

option to IB Release or Add Work. 

If no other work needs to be added to the line, the line will 

be released by selecting “IB Release” and entering

Remarks including an appropriate summary of all remarks 

entered in the Exam Results. If product was destroyed in 

the field as part of the field examination process, record 

what was destroyed in the Remarks field. Text entered in 

the Remarks field does not appear on the Notice of FDA 

Action. 

If work needs to be added to the line select “Add Work”. 

The system will take you to the Work Request and Work 

Request Details page to add work as appropriate. 

If the exam was classified as Class 2 with No Adverse 

Findings, but the line is to be held pending sample 

analysis of another line, follow Division procedures for 

notifying Compliance Branch. 

If the exam was classified as Class 3 you will have the 

option to Refer to CB or Add Work IB Release Remarks 

should include a detailed description of why the 

product was released if Adverse Findings were found. 

If “Yes” is chosen, the system will prompt you to return to 

the Possible Actions page to add work as appropriate.

If “No” is chosen, the system will display the message: 

“Performing Hold Designated/Others Go!” Click “OK”. 

The line will move to the Compliance Branch Grab Bag. 

Follow Division procedures for notifying the compliance 

branch. 

SUBCHAPTER 6.5 - IMPORT SAMPLE 

COLLECTION 

6.5.1 - GENERAL 

In general, the difference between official domestic and 

import samples is that import samples do not require official 

seals or collection of a 702(b) reserve portion. However, 

these are division options. See Chapter 4 for sampling 

instructions and guidelines. There are instances when the 

collection of a reserve portion and an official seal is 

warranted, i.e., when enforcement action (e.g., seizure, 

injunction, prosecution) is contemplated. Some sample 

sizes are provided in the Sample Schedule Section 

(Chapter 4). When using the sample sizes furnished 

elsewhere in this manual, do not collect the duplicate 

portion of the sample unless directed by your division. In 

addition, when preparing to collect import samples, you 

should be aware of your personal safety. Refer to IOM 

5.2.1.2.
CHAPTER 6 INVESTIGATIONS OPERATIONS MANUAL 2023 

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Import sub samples should be identified in accordance with 

IOM 4.7.2.1. However, if the sample number is not available 

at the time of shipment or sample delivery (e.g. a situation 

arises where the investigator collects the sample and must 

deliver it to a servicing lab prior to completing the collection 

report.) the entry/line number may be used in lieu of the 

sample number for identification. In these cases, complete 

the collection report as soon as possible and notify the 

sample custodian of the sample number. The collection 

report should clearly indicate how the sub samples are 

identified and provide reasoning as to why the sample 

number was not used.

Collect, prepare, handle, and ship import samples in a 

manner which assures the samples integrity. It is 

important that samples are packaged properly and labeled 

completely and legibly on the outside of the immediate 

sample container before delivery to the laboratory. This

allows the sample custodian to properly store the samples 

and expedite delivery to the appropriate laboratory branch. 

Attaching a Form FDA 525, Sample Package 

Identification, is not required; however, if a Form FDA 525 

is not used, the outside of the immediate sample package 

should be identified with the following: 

• Sample number, if available at time of shipment

• Entry/Line number if sample number not available 

at the time of shipment or sample delivery

• PAC/PAF (include all if multiple PAC/PAFs going 

to the same lab) see IOM 6.5.5

• Date of collection

• Storage Condition (ambient/frozen/refrigerated)

• Lead CSO’s initials

• The number of bags/cartons in sample if more 

than 1 and the sub numbers in each container, i.e. 

bag/box 1 of 3, subs 1-10, etc.

Note: If an FDA 525 is used, do not affix it on the outside of 

the shipping container.

Including a copy of the Collection Report (CR) is not 

required unless specifically requested by a lab.

FDA does not pay for import samples at the time of 

collection. The Importer should be advised they may bill the 

responsible division. FDA will not pay for violative import 

samples, per 21 CFR Part 1.91, see IOM 6.2.4.5.

When collecting IMPORT "ADDITIONAL Samples", the 

original Import Collection Report (CR) number should be 

used. Under OASIS, this will be the entry number with 

appropriate line information, etc.

Import Samples are compliance samples, except for those 

collected for pesticide analysis. See IOM Sample Schedule 

Chart 3 (Chapter 4) for guidance.

6.5.2 - PROCEDURES 

Review the submitted entry (electronic or hard copy 

documentation) to assure the location of the product(s) is 

known and the lots are available for FDA examination/ 

sampling before initiating action. The general description of 

the shipment in the entry documentation submitted to FDA 

should match the description of the product(s) in the invoice 

from the broker.

6.5.3 - TECHNIQUES 

Follow guidance furnished in IOM Subchapter 4.3 - 

Collection Technique.

6.5.4 - IMPORT FORMS PROCEDURES 

Because forms are now generated electronically by OASIS, 

individuals performing field examination or sample 

collections should follow guidance provided in the OASIS 

Training Manual, or consult their lead OASIS personnel.

6.5.5 - SAMPLE COLLECTION REPORTS 

See IOM 1.1 English language requirement. For every 

sample collected, a corresponding electronic collection 

report must be completed in OASIS. (See IOM Exhibit 6-

4.) 

Prior to completing the collection report, review the Line 

Details for the product sampled. You are responsible for 

making sure all fields in the Line Details screen are 

complete and correct. The Line Details screen is the only 

place you can make corrections to the entered data.

NOTE: If you start a collection report and need to exit at 

any time to make a correction in the Line Details you will 

lose the original collection report and a new lab number 

will be assigned when you return to the Collection Report 

screen. 

To review the Line Details: 

1. Access the Line Details screen by double clicking the 

work type field, i.e. “SAM”. This will open the 

Entry/Line Summary screen. Click the “Line Details” 

button. 

2. Review all data and verify that it is complete and

correct. For example, make sure the product code 

matches actual product, and that the manufacturer, 

country of origin, quantity and value are correct. Add 

any lot codes if applicable and update the Line 

Availability information if needed. If there is a build 

button on the line you need to correct, you must use 

the build function to make corrections. All fields that are 

white or highlighted in purple can be updated. 

3. If data has been changed, click the “Save” button, then 

enter a brief description in the pop-up box of 

corrections made. Assign fault to any errors as 

appropriate.
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4. After any changes are saved, click on “Rescreen” in the 

Application Tool bar to see if changing the data caused 

the line to hit on any other criteria or alerts.

Complete the OASIS Collection Report:

1. Highlight the line sampled in your Personal In Box and 

click on “Wk Detail” in the Application Toolbar.

2. If the line was sampled for more than one PAF, and 

analysis will be performed at the same laboratory, only 

one collection report should be generated; unless 

otherwise directed. Use Ctrl+Click to highlight all PAFs 

going to the same laboratory. 

NOTE: Collect a separate set of subs for each PAF unless 

otherwise directed by the laboratory or assignment. 

MIC/ELE samples cannot be split or shared between labs.

3. If the sample will be split and sent to more than one 

laboratory, highlight the PAF(s) for each laboratory 

individually and complete a separate collection report 

for each laboratory.

4. Click the “Work Result” button near the top right of the 

screen to access the Product Collection screen.

OASIS completes the following fields for you: Entry 

number, Investigator initials, Date Collected, Product 

Code, Product Code Description, Importers Corrected 

Description, Location of Goods, and the Lab Number. 

The Date Collected, and Location of Goods can be 

corrected on this screen if needed.

Enter data in the following fields:

6.5.5.1 - Collection Date

The Date Collected should reflect the date the sample was 

collected, not the date the sample was entered into OASIS. Only 

one date can be entered. If the sample collection was 

accomplished over several days use the last date of collection. 

Be consistent. This date should also be used to identify the 

physical sample. 

6.5.5.2 - 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). For 

example, samples of cantaloupes from Mexico reveal 

violative residues. Any destination point samples or 

subsequent compliance samples from the same shipper or 

grower would along with the original sample be considered 

an episode. Enter the episode number. See IOM 4.6.2.27.8. 

6.5.5.3 - Submitted To

To select the appropriate servicing laboratory, click the 

“Get Lab” button. The National Sample Distributor (NSD) 

is currently inactive. All lab capabilities have been set to 

“0”. Districts are instructed to submit samples utilizing the 

Servicing Laboratory Table (SLT) located in the ORA 

Workplan. If the servicing laboratory presented by the 

NSD does not match the specific assignment instructions 

or the SLT, override the NSD (See IOM 4.6.3). The NSDassigned laboratory can be overridden by choosing 

another laboratory from the drop-down menu. Override 

Reason must also be selected from the dropdown menu. 

Click “Proceed” to return to the collection report. The 

chosen laboratory should be displayed in the Submitted 

To field.

6.5.5.4 - Quantity Collected

Enter the number of sampled units you collected.

6.5.5.5 - Units

Select the appropriate units from the pull-down menu. The 

Calculated Cost will automatically populate based on the 

Value submitted in the Line Details, Quantity Collected and 

Units selected.

6.5.5.6 - DescText

Enter a description of the sample. The description should 

include:

1. Number of subs collected

2. Weight/volume of each sub

3. Brief product description

4. Type of container the subs were collected in 

5. Lot sampled 

Describe how you collected the sample:

Specify any special sampling techniques; if the 

sample was collected randomly, aseptically, 

selectively, etc. and the number of master cases 

collected from. 

For example: “Sample consists of 12 subs /16 oz. (1lb) 

each of IQF Cod Fillets collected at random from lot 

B129A1. Sample was collected aseptically from 12 

master cases and packed in 12 whirl-pak bags.”

Any text you enter in this field will be printed on the 

“Notice of FDA Action”. This field transfers to the “Sample 

Description” field in FACTS. 

6.5.5.7 - Hand Ship

Enter the method of shipping and describe how sample 

integrity is maintained including sample chain of custody. 

1. Describe how the sample was held and stored 

until shipment.

2. Include how the sample was prepared for shipping 

and 

3. Method of shipment 

For example: “Transported from firm in a closed cooler 

with gel packs, sample was then transferred to freezer #1 

in the locked sample room until shipped via UPS to PRLNW in a cooler with Gel packs.”

NOTE: This field does not transfer to FACTS for the 

laboratory to view. Please enter any special handling 

instructions in the Remarks field. 
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6.5.5.8 - Remarks

Enter any additional information that is pertinent to the 

sample collection such as:

1. Special handling instructions or storage condition 

requirements as necessary;

2. When applicable, note the use of guidance documents 

used for the collection such as Compliance Program 

Guidance Manuals, Assignment, or field examination 

guidance document.

3. Additional information your District, Laboratory, 

Compliance Program, Assignment, or Import 

Alert/Bulletin requires;

4. Any specific analysis instructions needed (i.e. any 

specific pathogen or mycotoxin screen needed.)

5. Any controls or photos collected

For example: “Store frozen. Master case code: 

PRODUCTION DATE 1319. Open and closed controls 

submitted with the sample. Analyze for milk protein per IB 

XX-BXX”

Or, “Store Ambient. Sample collected per DOPG-XXXXXXXX. Examined 200 units from lot 1234 for defects and 

identified 6 with pitting. Analyze for device integrity” 

This field transfers to the “Collection Remarks” field in 

FACTS. 

NOTE: Be sure to review the entire screen before clicking 

“OK.” The sample will be transferred immediately in 

FACTS to the respective laboratory once the OK button is 

clicked, (unless your supervisor has set up a supervisory 

review of your work). 

6.5.5.9 - Record Time Screen

The Record Time Screen will appear. Enter your time. If 

more than one person worked on the sample, click on “add” 

button to the right. A box will pop-up; enter the person’s 

initials and the tab key. Highlight the person’s name, click 

on OK. Enter other person’s time. Repeat for each person 

that worked on the sample. Click on OK Note: time is 

entered in decimal format for OASIS.

6.5.6 – Updating a Sample Collection 

Report

OASIS will allow users to make corrections to collection 

reports until the laboratory has set the sample to “In 

Progress” in FACTS. Note that a collection report may 

only be corrected once. To update a collection report, 

query the entry by clicking on “Query” and then “Entry”. 

From the Entry Query screen enter the entry number and 

click on “Execute Query”. Once you are at the Entry 

Details screen, select the line you want to update and click 

“All Activities”. Finally, double click on the “Product Collect 

Comp” field under the Pending text column to open the 

collection report and click the “Update” button. The 

updatable fields will become enabled for modification. 

They are Quantity Collected, Units, Desc Text, Hand/Ship 

and Remarks. Once all necessary changes have been 

made, click “Save”. At that point, the “View Update” button 

will become enabled. If a change was made to the 

Quantity Collected, Units, or Desc Text the “Print Notices” 

button will also be enabled. It is very important to generate 

and send the Notice that notifies the parties that changes 

were made to the collection data. 

NOTE: If a change was made to Hand/Ship or Remarks 

fields ONLY, then no new Notice is needed and the “Print 

Notices” button will not be enabled.

6.5.7- Special Domestic Import Samples 

(SDI)

The SDI sample work type should only be used when 

directed by a special sampling assignment, for certain 

perishable products collected for metal (MET) analysis or 

for products collected for nutritional analysis (NIS). It 

should not be used when collecting samples for multiple 

PAFs or if the product appears to be violative or has a 

history of being violative.

If a product is identified for collection as an SDI under a 

special sampling assignment, or other directive, follow the 

instructions outlined in the assignment or directive. 

SDI samples should be recorded per IOM 6.5.5 – Sample 

Collection Reports. Additionally, SDI samples require the 

following:

• A description of the product label as per IOM 4.5.9

- Product Label in the “Remarks” section.

o Include brand names and size of lot if not 

already recorded in the “Line Details” 

screen. 

• An official seal (Form FDA 415a) on the sample 

container(s).

o Follow instructions in IOM 4.7.4.3-

4.7.4.5.

• Collectors ID on the seal as per IOM 4.6.2.12

Collector’s ID on Seal.

o Include collectors ID on the seal in the 

“Remarks” section.

Note: This information is required for FDA to utilize its 

domestic authority if the sample analysis results are 

violative.

After sample collection time is recorded, the user will be 

prompted to “Add Work” or “IB Release”. The collector 

should select “IB Release” after any necessary work is 

completed. After the “SDI” sample work type has been 

recorded, additional work that would hold the line cannot 

be added. Once the line is released, the user should 

generate the Notice of FDA Action (NOA). The NOA will 

contain a section labeled “SAMPLES COLLECTED AND 

RELEASED” with additional language pertaining to the 

release of those lines. When the SDI line is released, the 

line will be closed. If all lines in the entry have been 

closed, the entry will be closed. 

The import compliance branch will be notified of and 

responsible for any necessary follow up (such as 
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submitting a screening criteria request and/or coordinating 

with the appropriate domestic division and program for 

follow-up actions) on SDI samples found to be violative.

SUBCHAPTER 6.6 - FILER EVALUATIONS 

6.6.1 - GENERAL 

The FDA makes admissibility decisions based on the 

electronic entry data transmitted to the FDA by the filers. 

The admissibility process is reliant upon data provided by 

parties outside of the FDA, most notably, the entry filers 

transmitting import entry information to the FDA on behalf 

of importers. As such, the FDA is dependent on entry filers 

to submit the most accurate data to make sound, riskbased admissibility decisions. 

The FDA conducts periodic filer evaluations to monitor the 

accuracy of entry data transmitted electronically to the 

FDA. Filer evaluations are conducted based on the 

physical location within an import division and may include 

entry lines transmitted by filers that are physically located 

within a different import division. Follow SOP-000217 

“Import Filer Evaluation” when conducting import filer 

evaluations.

SUBCHAPTER 6.7 - GLOSSARY OF 

IMPORT TERMS 

Refer to the “Glossary” for a more complete listing of import 

terms. Below is some common import language:

6.7.1 - American Goods Returned 

Goods produced in the U.S. which are exported, and then 

returned to the U.S. They are considered imports. (See 

Sec. 801(d)(1)of the FD&C Act [21 U.S.C. 381]). 

6.7.2 - Bonded Warehouse 

One of several classes of CBP Warehouses authorized to 

receive goods that have not been entered into the 

commerce of the US. Goods are entered into a Customs 

Bonded Warehouse (CBW) by a “formal entry” or 

“warehouse entry” requiring complete documentation for 

the entry, and payment of a fee, but not payment of duty 

and taxes. Goods in the warehouse can be held for up to 

5 years. After 5 years the goods must be entered, exported, 

or destroyed. Goods in a CBW can be manipulated, but 

except in certain smelting operations, cannot be 

manufactured into something else. If the CBW is located in 

the US, the goods are in interstate commerce and subject 

to the FD&C Act. See CPG Sec. 110.600 FDA Authority 

Over Products of Foreign Origin Located in Foreign Trade 

Zones, Bonded Warehouses or on Bonded Carriers

6.7.3 - Break-Bulk Cargo

Cargo transported in individual units, such as bags or 

cartons, which are not containerized.

6.7.4 - Consumption Entry (CE) 

” Entered for Consumption” means an entry summary for 

consumption has been filed with CBP in proper form, with 

estimated duties attached. The duty can be submitted 

electronically at the same time as the entry is transmitted 

or on a 15-day schedule when approved by CBP.

6.7.5 – Container Freight Station (CFS) 

Another location authorized to receive goods under 

customs Bond for the purpose of breaking bulk and 

redelivery of cargo. Containerized cargo can be moved 

from the place of unlading to a designated container station 

or may be received directly at the container station from a 

bonded carrier after transportation in-bond, before the filing 

of an entry of goods. 

6.7.6 - Date Collected

The date an import sample is collected.

6.7.7 - Date of Arrival 

The date a carrier transporting imported cargo arrives in the 

U.S.

6.7.8 - Date of Availability 

The date imported cargo is available/accessible for 

sampling by FDA. Goods may not be available for sampling 

as soon as they arrive in the U.S., due to the way the items 

were shipped/stored.

6.7.9 - Detention 

A temporary administrative action taken by FDA against 

articles offered for entry which are not or appears not to be 

in-compliance with the laws FDA administers. Detained 

articles can be released if brought into compliance, or are 

refused entry or seized, if not brought into compliance.

6.7.10 - Detention Without Physical 

Examination (DWPE) 

An action directed against specific products manufactured 

or shipped by specific foreign firms. "Import Alerts" list 

products which may be detained without physical 

examination due to their violative history or potential.
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6.7.11 - Domestic Import (DI) Sample 

A sample of an imported article collected after it has been 

released from import status. See IOM 4.1.4.2.5. 

6.7.12 - ENTRY 

Delivery or offer for delivery of merchandise into the 

Customs Territory of the U.S. from an outside point.

6.7.13 – ENTRY ADMISSIBILITY FILE 

Entry admissibility file refers to the file, hard copy and/or 

electronic, as appropriate, maintained by the District, which 

contains relevant documentation to support the District's 

admissibility decision.

6.7.14 - Entry Documents (Entry Package) 

Information submitted to CBP to determine the goods

quantity, its contents, and the parties of interest. Actual 

documentation for an individual entry can vary greatly, but 

it generally, consists of an invoice, purchase order, AWB 

and/or BOL. Entry documents can be submitted 

electronically to FDA, preferably through the Import Trade 

Auxiliary Communications System (ITACS) or via paper 

submission.

6.7.15 – FAILURE TO HOLD 

Failure to hold means that the goods have been distributed 

by the importer/consignee without an FDA release from 

import status. Such goods are usually subject to CBP's 

redelivery provisions. See IOM 6.7.31 – REDELIVERY 

BOND. 

6.7.16 - FILER 

A CBP term used to identify the individual or firm 

responsible for filing an entry. Also known as a Customs 

House Broker.

6.7.17 - Formal Entry 

The entry type required for shipments valued over $2500 or 

for shipments containing specific commodities designated 

by CBP. Formal entry is usually a three-step process, 

“Entry” – which gains the release of the goods from CBP 

control, “Entry Summary” – which includes determination of 

the classification and collection of the duty/taxes owed, and 

“Liquidation” – which is the finalization of the entry process 

and the completion of an CBP changes to classification and 

monies owed.

6.7.18 - Foreign Trade Zones 

Foreign Trade Zones (FTZ) are established under the 

Foreign Trade Zones Act. Goods properly admitted into an 

FTZ is considered outside the territory of the US for the 

purposed of duty and taxes. Several classes of goods are 

present in an FTZ at any one time. Some of these classes 

provide duty advantages when the goods are eventually 

entered into the commerce of the US. Other classes of 

goods are prohibited by law from entering the commerce 

and must be exported or destroyed. There is no time limit 

on how long goods can remain in an FTZ without entry or 

export. If the FTZ is located in the US, the goods are in 

interstate commerce and subject to the FD&C Act See CPG 

Sec. 110.200 Export of FDA Regulated Products from 

U.S. Foreign Trade Zones

6.7.19 - Immediate Delivery (ID)/ 

Conditional Release 

Entry/Immediate Delivery (CF 3461) must be filed within 15 

calendar days of arrival of goods in the U.S. Goods may 

be released for immediate delivery if it is arriving by land 

from Canada and Mexico. Products may be released for 

immediate delivery pending entry process completion. 

Even though CBP has allowed the immediate delivery, FDA 

regulated products are conditionally released until FDA 

makes an admissibility decision. The conditional release 

period ends when FDA May Proceeds the entry or issues a 

refusal.

6.7.20 - Import Alerts 

Import Alerts are guidance documents concerning 

significant re-occurring, new, or unusual problems affecting 

import coverage. They are available on the internet at 

https://www.fda.gov/ForIndustry/ImportProgram/ActionsEn

forcement/ImportAlerts/default.htm

6.7.21 - Importer of Record 

The party in whose name the entry is made. For example, 

a Customs House Broker might make an entry and become 

the “importer of record” by using his importer ID and bond 

on behalf of his client, the true “importer” of the goods. For 

FDA purposes, the “importer of record” is the person or 

company filing the redelivery bond under Sections 

802(b)and 536(b) of the FD&CAct [21 U.S.C. 382(b) and 

360mm(b)].

6.7.22 - Import Sections 

Import Sections (536, 801 and 802) are those sections of 

the FD&C Act containing the Import/Export Provisions

6.7.23 - Import Status 

Import Status is the standing of an article in the import 

database system which has not yet been released.

6.7.24 – IMPORTER MISDECLARATION 

Importer misdeclaration refers to the importer's providing 

incorrect and/or incomplete information to FDA and CBP, 

usually via the filer. This may include incorrect product 
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codes and/or product descriptions; incorrect/incomplete 

manufacturer/shipper name/address; incorrect quantity and 

value. It may occur as an attempt to avoid FDA and/or CBP 

actions/regulations such as DWPE, sampling, duties, etc.

6.7.25 - Informal Entry 

A simplified import entry procedure accepted at the option 

of CBP for any shipment not exceeding a specified value. 

Informal entries are filed with complete paperwork and any 

duties and taxes are paid at the time of filing. The entry 

liquidates at time of filing.

6.7.26 – Immediate Transportation (IT) 

An entry document filed with CBP by the importer. It allows 

the immediate transport of goods without a determination 

of admissibility, from the port of unloading under CBP bond. 

In general, the importer must file a consumption entry within 

6 months of the date of importation or export the goods. 

FDA typically examines these goods at an inland port of 

entry.

6.7.27 - Line (Line Item) 

A line is each portion of an entry which is listed as a 

separate item on an entry document. An importer may 

identify goods in an entry in as many portions as he 

chooses, except each item in the entry having a different 

tariff description and rate must be listed separately.

6.7.28 - LOT 

A lot is an entry, group of entries, or a portion of an entry of 

goods which can clearly be defined as appropriate for FDA 

sampling and examination purposes.

6.7.29 - MARKS 

Words or symbols, usually including the country of origin, 

marked on cartons, bags, and other containers of imported 

goods for identification purposes. Marks are a CBP

requirement.

6.7.30 - Port (Point) of Entry 

A port is the CBP location where the Consumption Entry is 

made. This may or may not be at the Port of Unloading (the 

point of physical entry into the U.S.)

6.7.31 - Redelivery Bond (AKA Entry 

Bond) 

A bond posted by the importer of record with CBP. For FDA 

regulated products, this is currently in the amount of three 

times the value of the imported product, to insure redelivery 

of the product for examination, reconditioning, export, or 

destruction.

6.7.32 - Stripping (Of Containers) 

Stripping is the removal of articles from transportation 

"Container" for examination or sampling.

6.7.33 – SUBSTITUTION 

Substitution is an attempt by the importer/consignee to 

present goods to the FDA as corresponding to a particular 

entry when they are in fact not the goods from that entry. 

May occur as an attempt to hide distribution without an FDA 

release and avoid CBP bond actions. See IOM 6.7.15, 

FAILURE TO HOLD.

6.7.34 - Supervisory Charges 

Supervisory charges are the charges for FDA supervision 

of the reconditioning and examination of articles after 

detention. (See 21 CFR 1.99).

6.7.35 - Warehouse Entry (WE) 

An entry document filed with CBP by the importer which 

allows the goods to go immediately into a bonded 

warehouse.

6.7.36 – VQIP QUALITY ASSURANCE 

PROGRAM 

VQIP Quality Assurance Program (QAP) is a compilation of 

the written policies and procedures used to ensure 

adequate control over the safety and security of the foods 

being imported by the VQIP importer. Any format can be 

used to organize the QAP to include all foods and all of the 

written policies and procedures under VQIP.

6.7.37 – FSVP AND/OR HACCP 

IMPORTER 

The importer who, for a specific food, is subject to the 

importer requirements in FDA’s FSVP regulation, (21 CFR 

part 1, subpart L) or the requirements applicable to 

importers in the juice or seafood HACCP regulations (21 

CFR 120.14 and 123.12, respectively). Under both the 

FSVP and the HACCP importer regulations, the importer is 

the U.S. owner or consignee at the time of entry into the 

United States or the U.S. agent or representative of the 

foreign owner or consignee at the time of entry into the 

United States (21 CFR 1.500 (FSVP)); 21 CFR 120.3(h) 

(juice HACCP); and 21 CFR 123.3(g) (seafood HACCP)). 

An FSVP or HACCP importer must be physically located in 

the United States. When the FSVP or HACCP importer for 

a food is a U.S. agent or representative for the foreign 

owner or consignee, the U.S. agent or representative is 

responsible for meeting the FSVP or HACCP requirements 

with respect to that food.

6.7.38 – DATA UNIVERSAL NUMBER 

SYSTEM (DUNS) 

A DUNS number is a unique nine-digit business 

identification number provided by the company Dun & 
CHAPTER 6 INVESTIGATIONS OPERATIONS MANUAL 2023 

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Bradstreet (D&B). Upon request, D&B will assign a DUNS 

number for each physical location of a business.

6.7.39 – FOOD SAFETY MODERNIZATION 

ACT (FSMA) 

The FDA Food Safety Modernization Act (Pub. L. 111-353) 

enables FDA to better protect public health by 

strengthening the food safety system. It enables FDA to 

focus more on preventing food safety problems rather than 

relying primarily on reacting to problems after they occur. 

The law also provides FDA with new enforcement 

authorities designed to achieve higher rates of compliance 

with prevention and risk-based food safety standards and 

to better respond to and contain problems when they do 

occur. The law also gives FDA important new tools to hold 

imported foods to the same standards as domestic foods 

and directs FDA to build an integrated national food safety 

system in partnership with state and local authorities.

6.7.40 – FOREGIN SUPPLIER 

VERFICATION PROGRAM (FSVP) 

FSVP is a program that importers covered by the rule must 

have in place to verify that their foreign suppliers are 

producing food in a manner that provides the same level of 

public health protection as the U.S. safety standards, 

including the preventive controls or produce safety 

regulations as appropriate, and to ensure that the supplier’s 

food is not adulterated and is not misbranded with respect 

to allergen labeling. 

SUBCHAPTER 6.8 FOREIGN SUPPLIER 

VERIFICATION PROGRAM 

6.8.1 - FSVP INSPECTIONS 

FSVP inspections are conducted to verify human and 

animal food imported into the United States is as safe as 

food produced and sold within the United States. 

The FSVP website contains resources for legal, 

regulatory, guidance, and policy issues for the FSVP 

regulation. 

6.8.1.1 - Pre-Inspection Activities 

Prior to conducting an FSVP inspection, contact the 

person identified at entry as the FSVP importer by phone. 

During the pre-inspection phone call, you should:

1. Identify yourself and inform the importer that FDA will 

be conducting an FSVP inspection.

2. Verify the firm or person identified at entry is the 

"importer" as defined in 21 CFR 1.500.and the 

imported food is subject to the FSVP regulation.

3. Verify the importer’s contact information (e.g., name, 

email address, phone number, and physical address).

4. Determine whether the importer of the food is a 

manufacturer/processor or re-packer and should be 

inspected under other programs, such as the Current 

Good Manufacturing Practice, Hazard Analysis, and 

Risk-Based Preventive Controls for Human Foods 

Regulation (Preventive Controls for Human Foods 

Rule) or Current Good Manufacturing Practice, 

Hazard Analysis, and Risk-Based Preventive Controls 

for Animal Foods Regulation (Preventive Controls for 

Animal Food Rule).

5. Determine whether the importer of produce is a 

grower, and should be inspected under the Standards 

for the Growing, Harvesting, Packing, and Holding of 

Produce for Human Consumption (Produce Safety 

Rule). 

6. Verify the FSVP records are available onsite. If the 

records are offsite, advise the importer that he/she will 

need to retrieve the records.

7. Determine if any FSVP records need to be translated. 

6.8.1.2 - Preparation and References 

Before undertaking an inspection:

1. Review the firm’s FSVP inspection history, the 

compliance history of the products, and the 

foreign supplier associated with the products 

targeted for FSVP review. Ensure the highest risk 

products are covered. 

2. Prepare a list of the foods imported by the 

importer and the foreign supplier for each food. 

3. Review the entry date of the assigned products 

and the associated foreign suppliers to ensure the 

compliance date has passed.

4. Conduct the pre-inspectional hazard analysis to 

determine the known or reasonably foreseeable 

hazards that should be addressed in the 

importer’s hazard analysis, if applicable.

5. Review and become familiar with the appropriate 

parts of the FSVP regulation 21 CFR Part 1, 

subpart L. 

6. Ensure that you have received all necessary 

training that may be required. Consult your 

supervisor with questions.

6.8.1.3 - Inspectional Authority 

Authority to review records required of FSVP importers 

falls under the statutory provisions of section 805 of the 

FD&C Act, 21 CFR 1.510(b)(1), 21 CFR 1.510(b)(3), 21 

CFR 1.512(b)(5)(ii)(A), and/or 21 CFR 1.512(b)(5)(ii)(C).

See IOM subchapter 2.2 for broader information on 

inspectional authority.

6.8.1.4 - FSVP Inspectional Activities 

Upon arrival at the firm locate the person identified at 

entry as the FSVP importer. Introduce yourself by name, 

title and organization. Show your credentials, explain the
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purpose of the inspection, and issue a properly signed, 

completed original of the Form FDA 482d, Request for 

FSVP Records (the division office address should be the 

pre-alignment district office associated with the importer’s 

geographical location). 

If this is an initial inspection, provide FSVP education 

materials. Briefly explain the fact sheets and refer the 

importer to additional documents that can be found on the 

FDA.gov FSVP website.

See IOM subchapter 5.2.2 for general information on 

issuing the Notice of Inspection.

6.8.1.4.1 - CONDUCTING THE FSVP 

RECORDS REVIEW

Review the importer’s required FSVP records for the 

products and foreign suppliers as assigned or as needed 

to ensure appropriate coverage of the firm’s FSVP 

programs. When following up on an inspection during 

which an FDA 483a was issued, review the FSVP records 

for the observations documented on the FDA 483a during 

the previous inspection. Determine whether the importer 

corrected the observations that were identified during the 

previous inspection and what corrective actions were 

taken. Verify that those actions corrected the 

observations.

For each FSVP product reviewed during the inspection, 

review documentation that the importer meets the 

definition of "importer" as defined in 21 CFR 1.500. 

Review the prepared list of the imported foods with the 

importer and document which foods do not have an FSVP 

plan.

If the importer is required to comply with the requirements 

in section 1.504, request to review the importer’s hazard 

analysis. It is important to determine if the importer 

identified any known or reasonably foreseeable hazards 

for each food. Compare your pre-inspection hazard 

analysis to the importer’s hazard analysis. If there are 

discrepancies, discuss with the importer to determine their 

reasoning behind the discrepancy. After reviewing the 

importer’s hazard analysis, request to review the 

necessary records. 

If the importer states that they do not have an FSVP, 

determine whether the importer maintains records that 

satisfy the FSVP requirements. Importers may not be 

aware of the specific requirements of the FSVP regulation, 

but upon further questioning, may be able to provide 

documents that fulfill FSVP requirements. Encourage the 

importer to take corrective actions for deviations observed 

during the inspection. 

If the records review indicates there may be a public 

health concern relating to a food or foreign supplier 

(evidence that the food is adulterated or misbranded or 

that there are significant deficiencies at the foreign 

supplier), determine whether the importer took appropriate 

corrective actions and documented the corrective actions 

taken. For example, if an importer’s sampling and testing 

records indicate that a sample was positive for 

Salmonella, determine whether the importer took 

appropriate corrective actions (e.g., importer did not 

import the food, imported food was recalled, importer 

worked with the foreign supplier to address the problem, 

importer discontinued use of the foreign supplier). In 

addition, document and collect available information 

relating to the food and foreign supplier, document FSVP 

observations on the Form FDA 483a, when applicable, 

and report the findings to your supervisor.

Document all discussions with the importer as it relates to 

FSVP and the records review in the EIR.

6.8.2 - FSVP OBSERVATIONS 

The FDA 483a, FSVP Observations is intended to assist 

firms inspected in complying with the laws and regulations 

enforced by the Food and Drug Administration. The FDA 

483a notifies the inspected establishment’s top 

management in writing of significant objectionable 

conditions relating to violations of the FD&C Act which 

were observed during the inspection. The issuance of 

written inspectional observations is mandated by law and 

ORA policy.

6.8.2.1 - Preparation of Form FDA 483a

The FDA 483a should be issued at the conclusion of the 

inspection and prior to leaving the premises. During the 

inspection, do not show the firm’s management a draft, 

unsigned copy of the FDA 483a or an electronic copy of 

the FDA 483a on your computer screen. You should issue 

only a signed FDA 483a at the closeout discussion with 

management.

The FDA 483a should adhere to the following general 

principles:

1. Observations which are listed should be significant 

and correlate to regulated products being inspected.

2. Observations of questionable significance should not 

be listed on the FDA 483a, discuss these 

observations with the firm’s management so that they 

understand how uncorrected problems could become 

a violation. Detail this discussion in the EIR.

The FDA 483a should have the following characteristics:

1. Each observation should be clear and specific.

2. Each observation should be significant and ranked in 

order of significance.

3. All copies of the FDA-483a should be legible.

If an observation made during a prior inspection has not 

been corrected or is a recurring observation, it is 

appropriate to note this on the FDA 483a and document in 

the EIR. Corrective actions are not listed on the FDA 483a 

but are reported in the EIR.
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The products and foreign supplier inspected must be 

identified on the FDA 483a when documenting an 

observation for the importer’s lack of an FSVP. 

Collect documentation to support observations. Do not 

copy records that do not support observations, unless 

otherwise directed. Contact your supervisor if unsure of 

the evidence required to support an observation.

Generate the FDA 483a in eNSpect. To generate the FDA 

483a, complete the FSMA and FSVP Inspection Protocol 

(IP) for each FSVP product that is reviewed.

At the close of the inspection, provide the importer with a 

copy of the FDA 483a and discuss each observation. Also 

discuss non-significant observations not documented on 

the FDA 483a. Encourage the importer to make voluntarily 

corrective actions.

During the closeout discussion with the FSVP importer, 

inform the importer that they should respond to the FDA 

483a within 15 business days after the end date of the 

inspection and that their response may impact FDA’s 

determination of the need for follow-up action. Provide 

information to the importer on where to send their 

response according to their division’s procedures (i.e., the 

address of the Division office associated with the 

importer’s geographical location that is listed on the FDA 

483a or FDA 483a response e-mail address associated 

with the applicable division). Hard copies of inspections 

records should be stored at the pre-alignment district 

office associated with the importer’s geographical location.

6.8.2.1.1 - INDIVIDUAL HEADINGS

District Office Address and Phone Number – Legibly 

print the district office address where the firm is physically 

located, regardless of investigator’s division or duty 

station. Include the district office commercial telephone 

number and area code.

For example, if a firm is located in Salt Lake City, UT then 

the district office would be Denver District Office. See 

Appendix E for boundary maps. 

Name and Title of Individual to Whom Report Is Issued 

- Enter legal first name, middle initial and last name and 

full title of the person to whom the form is issued.

Firm Name - Enter full, legal name of the firm, including 

any abbreviations, quotation marks, dashes, commas, etc.

Street Address - Enter street address (Not P.O. Box 

unless P.O. Box is part of the address such as on a Rural 

Route).

City, State and ZIP Code - Enter city, state and ZIP 

Code.

E-Mail Address – Enter Email address for the FSVP 

contact at the firm.

Date(s) of Review of your FSVP Records- Enter actual 

or inclusive date(s) of inspection.

FEI Number - If the FDA Establishment Identifier is on the 

assignment, enter it here. If not readily available, leave 

blank.

Employee(s) signature and Employee(s) name and 

title - The names of everyone who participated in the 

inspection with the issuance of an FDA 482d should be 

listed on the FDA 483a even if they are not available to 

sign the FDA 483a. Each member of an inspection team 

should sign the FDA 483a. However, absence of a team 

member at the conclusion of an inspection need not 

prevent issuance of the FDA 483a. See IOM 5.1.2.5.1. If 

you use an eNSpect-generated FDA 483a, assure you 

have a copy for the program division files -- an unsigned 

photocopy or printed duplicate is unacceptable. See IOM 

5.2.3.6.2.

6.8.2.1.2 - SIGNATURE POLICY

Everyone present at issuance signs the first and last 

pages of the FDA 483a and initials each intervening page 

in the signature block. The lead CSO’s signature will 

appear on all pages of the FDA 483a and the remaining 

team members’ signature will appear on the last page.

See IOM 5.2.3 for more information on Reports of 

Observations.

SUBCHAPTER 6.9– FSVP REPORTING 

Following an inspection, you are required to prepare a 

report of your findings. Reporting includes the data and 

summary entered using eNSpect, a narrative report, 

attachments and exhibits. Your narrative report should be 

prepared to accurately and concisely communicate the 

findings of your inspection and be adequate for its 

intended use.

6.9.1– ESTABLISHMENT INSPECTION 

REPORT (EIR)

Based on the observations documented on the FDA 483a 

and other information captured on the IP in eNSpect, you 

will use the FSVP Establishment Inspection Report (EIR) 

application in the eNSpect system to generate the EIR. 

The requirement to answer IP Question 1.5.1. replaces 

the requirement to complete the PRA “Memorandum to 

File”; document the reason for selecting the importer for 

inspection in the EIR. Write the EIR according to this 

subsection and IOM subchapter 5.11. 

6.9.1.1- FSVP RECORDS REVIEW

Document the review of the importer’s required FSVP 

records in the EIR. Identify the product and foreign 
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supplier covered by each FSVP. Report the results of the 

comparison of your pre-inspection hazard analysis and the 

importer’s hazard analysis, if conducted, and any resulting 

discussion with the importer. This information must be 

documented with sufficient detail to demonstrate the firm’s 

compliance with FSVP or lack thereof. 

For each product covered during the inspection, verify that 

the importer meets the definition of “importer” and 

document in the EIR as follows:

1. If the importer was the owner or consignee 

when the food was offered for entry into the U. 

S., attach a copy of a purchase order or some 

other documentary proof. 

2. If the importer was the U. S. agent or 

representative when the food was offered for 

entry into the U.S., attach a copy of the written 

agreement to serve as the FSVP importer.

3. If the importer does not meet the definition of 

importer, explain this determination in the EIR 

and obtain information on the actual importer. 

Document all corrective actions taken by the importer to 

correct the observations that were identified during the 

previous inspection. Describe what corrective actions 

were taken and whether those actions corrected the 

observations. Document any immediate corrective actions 

that the importer took during the inspection and any 

corrective actions promised for completion in the future, 

including when they expect to complete the corrective 

action. In addition, document any corrective actions taken 

during the inspection in the corrective action reporting 

system (CARS) within eNSpect
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6-1 Notice of FDA Action
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6-2 FORM FDA 766 – Application for Authorization to Relabel or Recondition NonCompliant Articles 
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6-3 Form FDA 790 Charges for Supervision
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6-4 Sample Collection in OASIS Screen Shot

Desc Text:

Hand/Ship:

Remarks:
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6-5 FORM FDA 463a AFFIDAVIT