INVESTIGATIONS OPERATIONS MANUAL 2023 CHAPTER 8

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CHAPTER 8 - INVESTIGATIONS

8.1 - INVESTIGATIONS AND INSPECTIONS ........................................................................................8-4

8.1.1 – BACKGROUND – WHAT IS AN INVESTIGATION? ................................................................................8-4

8.1.2 - INVESTIGATIONS, INSPECTIONS, AND FORM 482? – WHEN DO YOU ISSUE AN FDA 482? ...........................8-4

8.1.3 - EXTERNAL REQUESTS FOR INVESTIGATIVE INFORMATION – WHAT IF SOMEONE ASKS YOU ABOUT AN 

INVESTIGATION? .................................................................................................................................8-4

8.1.4 - OFFICE OF CRIMINAL INVESTIGATIONS – WHO IS OCI?.......................................................................8-5

8.1.4.1 - OCI RESPONSIBILITIES ....................................................................................................................... 8-5

8.1.4.2 - REPORTS OF CRIMINAL ACTIVITY ......................................................................................................... 8-5

8.1.4.3 - LIAISON WITH LAW ENFORCEMENT /INTELLIGENCE COMMUNITY ............................................................. 8-5

8.1.5 - TYPES OF INVESTIGATIONS – WHAT SITUATIONS LEAD TO INVESTIGATIONS? ............................................8-5

8.1.5.1 - DEFECTIVE PRODUCTS ....................................................................................................................... 8-6

8.1.5.2 - INJURY, ILLNESS, DEATH..................................................................................................................... 8-6

8.1.5.3 - CRIMINAL INVESTIGATIONS................................................................................................................. 8-6

8.1.5.4 - SURVEILLANCE.................................................................................................................................. 8-7

8.1.5.5 - WASHOUTS ..................................................................................................................................... 8-7

8.1.5.6 - FOR CAUSE/FACT-FINDING/INFORMATION GATHERING.......................................................................... 8-7

8.1.5.7 - COMPLAINTS.................................................................................................................................... 8-8

8.1.5.8 - DISASTER/EMERGENCY RESPONSE – HOW DO WE PROTECT THE CONSUMER DURING A DISASTER OR EMERGENCY?

................................................................................................................................................................. 8-10

8.1.5.9 - COUNTERFEITING AND TAMPERING.................................................................................................... 8-18

8.1.6 - GENERAL INVESTIGATIVE TECHNIQUES – WHAT DO I DO DURING AN INVESTIGATION? ............................. 8-23

8.1.6.1 - INTERVIEWS ................................................................................................................................... 8-23

8.1.6.2 - MEDICAL RECORDS ......................................................................................................................... 8-24

8.1.6.3 - SAMPLE COLLECTION....................................................................................................................... 8-26

8.1.6.4 - INTERNET INVESTIGATIONS ............................................................................................................... 8-27

8.1.7 - LOCATIONS FOR INVESTIGATIONS – WHERE COULD YOU CONDUCT AN INVESTIGATION? ............................ 8-27

8.1.8 - INTERNAL AND EXTERNAL ORGANIZATIONS INVOLVED - WHO ELSE WILL I ENCOUNTER DURING AN 

INVESTIGATION? WHY ARE THEY INVOLVED? ............................................................................................ 8-27

8.1.8.1 - INTERAGENCY REFERRAL .................................................................................................................. 8-28

8.1.8.2 - INTRA-AGENCY/CROSS-PROGRAM..................................................................................................... 8-28

8.1.9 - GENERAL INVESTIGATION REPORTING - HOW DO I REPORT MY INVESTIGATION? HOW DO I GET CREDIT FOR THE 

TIME I SPENT ON IT?........................................................................................................................... 8-28

8.1.9.1 - ENTERING INVESTIGATION OPERATIONS IN ENSPECT ............................................................................. 8-29

8.1.9.2 - INVESTIGATION MEMO: FORMAT, CONTENT, ENDORSEMENT, AND ROUTING............................................. 8-30

8.1.9.3 - REPORTING COMPLAINTS/FOLLOW-UPS.............................................................................................. 8-30

8.1.9.4 - REPORTING INFORMATION OBTAINED FROM A CONFIDENTIAL INFORMANT ............................................... 8-31

8.1.9.5 - REPORTING INVESTIGATIONS CONDUCTED DURING DISASTER RESPONSE ................................................... 8-31

8.2 - HUMAN AND ANIMAL FOOD INVESTIGATIONS....................................................................... 8-32

8.2.1 - COORDINATION ...................................................................................................................... 8-32

8.2.2 - FOODBORNE ILLNESS OUTBREAK INVESTIGATIONS........................................................................... 8-32

8.2.2.1 - COOPERATION WITH OTHER AGENCIES............................................................................................... 8-32

8.2.2.2 - OUTBREAKS ON FOREIGN FLAG VESSELS ............................................................................................. 8-33
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8.2.2.3 - OUTBREAKS INVOLVING INTERSTATE CONVEYANCES ............................................................................. 8-33

8.2.2.4 - OUTBREAK MANAGEMENT............................................................................................................... 8-34

8.2.2.5 - CONDUCTING FOODBORNE ILLNESS FOLLOW-UP.................................................................................. 8-34

8.2.2.6 - REPORTING.................................................................................................................................... 8-41

8.2.3 - INJURY, ILLNESS, DEATH ........................................................................................................... 8-43

8.2.3.1 - PROCEDURES ................................................................................................................................. 8-43

8.2.3.2 - SPECIFIC PRODUCT REPORTING (FOOD, DIETARY SUPPLEMENT, AND COSMETIC – INJURY OR REACTION) ...... 8-44

8.2.3.3 - VETERINARY PRODUCTS-COMPLAINTS/ADVERSE REACTIONS ................................................................. 8-47

8.2.3.4 - SAMPLE COLLECTION....................................................................................................................... 8-47

8.2.4 - SPECIAL EVENTS...................................................................................................................... 8-47

8.2.5 - FARM INVESTIGATIONS............................................................................................................. 8-48

8.2.6 - INFANT FORMULA AND BABY FOOD............................................................................................. 8-49

8.2.7 - TAMPERING INVOLVING ALCOHOLIC BEVERAGES............................................................................. 8-50

8.3- DRUG INVESTIGATIONS .......................................................................................................... 8-51

8.3.1 - INVESTIGATIONS COORDINATION ................................................................................................ 8-51

8.3.2 - ILLNESS/INJURY ...................................................................................................................... 8-51

8.3.2.1 - REPORTING.................................................................................................................................... 8-52

8.3.3 - COMPLAINTS.......................................................................................................................... 8-52

8.4 - DEVICE INVESTIGATIONS ....................................................................................................... 8-54

8.4.1 - INJURY/ILLNESS ...................................................................................................................... 8-54

8.4.1.1 - TYPES OF DEVICE INJURIES OR ILLNESSES INCLUDE: ................................................................................ 8-54

8.4.2 - CONFIDENTIAL INFORMANTS...................................................................................................... 8-56

8.4.3 - COMPLAINTS.......................................................................................................................... 8-56

8.4.4 - REPORTING ........................................................................................................................... 8-56

8.4.5 – MEDICAL DEVICE SAMPLING .............................................................................................. 8-57

8.5 - BIOLOGICS INVESTIGATIONS.................................................................................................. 8-58

8.5.1 - ILLNESS/INJURY ...................................................................................................................... 8-58

8.5.1.1 - REPORTING.................................................................................................................................... 8-58

8.5.2 - SURVEILLANCE........................................................................................................................ 8-60

8.5.3 - CONFIDENTIAL INFORMANTS...................................................................................................... 8-60

8.5.4 - COMPLAINTS.......................................................................................................................... 8-60

8.5.4.1 - BIOLOGICAL PRODUCTS ............................................................................................................. 8-60

8.5.4.2 -BIOLOGICAL SAMPLES ...................................................................................................................... 8-61

8.5.4.3 - BIOLOGICS INJURY/ADVERSE REACTION REPORTS .................................................................... 8-61

8.6 - BIORESEARCH MONITORING INVESTIGATIONS....................................................................... 8-62

8.6.1 - ILLNESS/INJURY ...................................................................................................................... 8-62

8.6.1.1 - REPORTING.................................................................................................................................... 8-62

8.6.2 - SURVEILLANCE........................................................................................................................ 8-62

8.6.3 - COMPLAINTS.......................................................................................................................... 8-62

8.7 - TOBACCO INVESTIGATIONS ................................................................................................... 8-63

8.7.1 - INVESTIGATIONS COORDINATION ................................................................................................ 8-63

8.7.2 - COMPLAINTS.......................................................................................................................... 8-63

EXHIBITS....................................................................................................................................... 8-65

8-1 FEDERAL ANTI-TAMPERING ACT FULL LANGUAGE.................................................................. 8-65

8-2 LETTER TO HEALTHCARE PROVIDER FOR MEDICAL RECORDS.................................................. 8-66
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8-3 INVESTIGATION MEMO ........................................................................................................ 8-67

8-4 TABLE OF INCIDENT COORDINATION..................................................................................... 8-68

8-5 CIFOR OUE AGENT LIST ......................................................................................................... 8-70

8-6 – VAERS FORM ..................................................................................................................... 8-77

8-7 MEDWATCH FORM............................................................................................................... 8-81

8-8 POTENTIAL TOBACCO PRODUCT VIOLATIONS FORM.............................................................. 8-84

8-9 – DISASTER RESPONSE FLOW DIAGRAM................................................................................ 8-87

INDEX........................................................................................................................................... 8-92
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8.1 - Investigations and Inspections 

8.1.1 – Background – What is an investigation?

An investigation is an information-gathering activity conducted for several reasons and this definition 

applies across ORA programs. The purpose of an investigation is to determine and document facts 

concerning an issue to inform the agency in making sound decisions. Used informally, investigation can 

apply to a very general activity. It may refer to a response to a more formal request for specific 

information. Information obtained during an investigation may lead to other operations such as sample

collections or inspections. 

This chapter contains specific information on many types of investigations, and each section provides 

guidance on how to conduct those investigations, special reporting requirements, and where additional 

assistance can be obtained. Recall work, a special type of investigation, is covered in Chapter 7. 

Reporting an investigation is covered in Section 8.1.9 of this chapter.

8.1.2 - Investigations, Inspections, and Form 482? – When do you issue an 

FDA 482?

Investigations generally do not require an FDA 482, but there will be times when you need to issue an 

FDA 482, such as when you are at a manufacturing site or doing work like an inspection (e.g., collecting 

records at a manufacturer or shipper to document interstate commerce). Consult with your supervisor 

to determine the proper course of action for these situations. Investigations may be performed at a 

location not subject to FDA inspection.

8.1.3 - External Requests for Investigative Information – What if someone 

asks you about an investigation?

Investigations will naturally lead to interest from outside groups. Consumers, industry, press, and other

external stakeholders may want information about your investigations. Do not reveal any information 

about an investigation to anyone outside of the agency without express permission. Direct any requests 

for information to the FDA’s How to Make a FOIA Request webpage (https://www.fda.gov/regulatoryinformation/freedom-information/how-make-foia-request). Refer all media inquiries to the ORA Press 

Office at ORAPress@fda.hhs.gov (see IOM 1.7).

In the case of complaints where a sample has been collected from the complainant they may be 

informed of FDA's findings when an examination is made of the sample. When you collect a sample from 

a complainant, and they ask for analytical results, they may be told that the FDA will advise them of the 

general nature of the findings. Enter the complainant’s contact information (name, address, phone 

number and email) into the Collection Remarks. Be sure to consult with your supervisor prior to 

collecting samples from a complainant. See IOM 4.4.3.3 and IOM 4.6.2.9.
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8.1.4 - Office of Criminal Investigations – Who is OCI?

8.1.4.1 - OCI Responsibilities

ORA’s Office of Criminal Investigations (OCI) has the primary responsibility for all criminal 

investigations conducted by the FDA, including suspected tampering incidents and suspected 

counterfeit products. Similarly, OCI has primary responsibility — and is the primary point of contact 

for — all law enforcement and intelligence matters.

8.1.4.2 - Reports of Criminal Activity

All reports of suspected or confirmed criminal activity, including suspected tampering or 

counterfeiting incidents, must be reported to the appropriate OCI field office or resident office 

without delay. Additionally, all threats or perceived threats against FDA-regulated products are to be 

referred immediately to the local OCI field office or to OCI headquarters. In those instances where 

OCI does not, or cannot initiate a criminal investigation in a timely manner, the division offices will

consult with OCI to determine the proper follow-up.

8.1.4.3 - Liaison with Law Enforcement / Intelligence Community

OCI is the FDA's liaison with the law enforcement community for criminal investigations and 

related matters. In addition, OCI serves as the primary point of contact between the FDA and 

the intelligence community on all matters of mutual interest. OCI participates in numerous law 

enforcement and intelligence task forces both nationally and internationally including as a fulltime representative at Interpol.

All contacts regarding requests or questions received from federal, state, or local law 

enforcement agencies or intelligence agencies are to be referred without delay to the local OCI

field office. Similarly, law enforcement contacts to FDA headquarters or centers should be 

referred to OCI headquarters. 

When FDA personnel receive information or requests from law enforcement or other agencies, 

they should obtain the caller's name, organization, and the details of the request. The caller 

should then be referred to the appropriate OCI component. After referring the caller to OCI, 

contact the affected OCI unit to provide the caller's information. This will prepare OCI of the 

expected contact. FDA personnel should not respond to inquiries concerning criminal 

investigations, including questions seeking confirmation of whether FDA is or is not conducting a 

criminal investigation.

8.1.5 - Types of Investigations – What situations lead to investigations?

You may conduct a variety of investigations in your career. Some types of investigations include, but are 

not limited to complaint investigations, disaster investigations, health fraud investigations, and product 

tampering investigations. When conducting any investigation, keep an open mind. Each investigation 

will be unique.
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8.1.5.1 - Defective Products

A defective product is one that fails to do what it is expected to do. For example, a diabetes 

medication that fails to adequately control blood sugar levels that is prescribed for that reason. A 

defective product will typically result in a recall where the product may be destroyed or 

reconditioned. 

Investigations into defective products could be initiated as a result of consumer or industry 

complaints that may indicate the need for follow up with the consumer or industry representative, 

which would be conducted as an investigation. Investigations are initiated in order to determine 

facts surrounding a claim related to the status or disposition of a subject FDA-regulated product.

Subsequent findings would determine necessary follow-up and/or FDA action (e.g., inspection, 

sampling, product recall). 

8.1.5.2 - Injury, Illness, Death

Immediate follow up action should be made when there is indication of a serious injury or adverse 

reaction, including illness and death. Follow up may vary depending on the situation. You may be 

asked to conduct investigations at complainants’ residences or at firms to investigate any potential 

causes for the adverse reaction. Inspections at firms may also be warranted. These investigations 

could be assigned by Office of Emergency Operations (OEO), the Coordinated Outbreak Response 

and Evaluation (CORE) Network, or other agency components. 

You may need to collect medical records or in some cases autopsy reports during these 

investigations. (See Section 8.1.6.2 of this Chapter for guidance on obtaining medical records.)

When discussing complaints with a firm representative, do not provide any identifying information 

of the complainant, for example, name, phone number, or city or state of residence. Reports of 

adverse reactions may be received from consumers or health care professionals through voluntary 

reporting such as MedWatch. Reports may be received from state or federal partners. These reports 

should be treated as confidential. 

NOTE: Follow any program specific guidance related to investigation preparation, collection of these 

records, etc.

8.1.5.3 - Criminal Investigations

During your work, you may encounter situations that involve criminal or fraudulent activity as 

defined under Title 18 USC and Title 21 USC. Criminal activity noted by FDA consumer safety officers 

(CSO) is typically cases of individuals and/or firms making false statements or providing false 

documents during the course of an inspection or other official activity. There are other violations of 

Title 18 and criminal violations of Title 21 USC that you may encounter.

Fraud is a separate criminal act from false statements and involves a false representation of a 

matter of fact whether by words or by conduct, including concealment of information, intended to 

deceive another for advantage. 
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In all cases of criminal activity including fraud, OCI is the primary investigative office for FDA. Gather 

as much initial information as possible and notify your supervisor. You may be asked to assist OCI in 

its investigation. If so, follow their directions and do not discuss the investigation with anyone 

outside of the investigation.

8.1.5.4 - Surveillance

During your inspectional, investigational, and other activities, be alert to anything which may be 

new or unusual or interesting from FDA's viewpoint such as:

• New firms.

• New products.

• New production and distribution practices.

• New equipment and industrial processes.

• Seasonal practices.

• Industry trends.

• Recent or on-going construction and plans for future expansion.

• Proposed products.

• New ideas the firm is contemplating.

• New products in the development stage.

• Activities about a firm's competitor.

• Plans for consolidation, mergers, diversification, etc.

If this information relates to a firm you are not currently inspecting, report the information using a 

Memo of Investigation and route through your supervisor appropriately. If the information relates 

to a firm being inspected report in the Establishment Inspection Report (EIR). (See Section 8.1.9 for 

details on reporting your investigation.)

8.1.5.5 - Washouts

A “washout” is defined as an operation where you are unable to complete an assigned inspection. 

When you encounter a washout, you should determine the reason you are unable to conduct the 

inspection. For example, a firm that operates seasonally may be available for inspection later in the 

year. If a firm has moved, attempt to find the forwarding address of the firm. If the firm remains in 

the local area, do not treat it as a washout but conduct the inspection at the new location. Each 

washout should be investigated so that you are able to explain why you could not conduct the 

inspection. (See Section 8.1.9 for details on reporting your investigation.)

8.1.5.6 - For Cause/Fact-Finding/Information Gathering

A for cause, fact-finding, or information gathering investigation is generally received by the division 

from an outside source like a center, ORA headquarters, or another division. It will generally be a 

request to obtain specific information from a firm or other source. One example could be obtaining 

interstate documentation from a shipper of a product to support a regulatory action, such as a 

seizure in another division. 
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8.1.5.7 - Complaints

A complaint is a notification that a product may be adulterated or misbranded. A complaint may be 

related to the following areas:

• Economic problems/misbranding (i.e., labeling). 

o Short weight. 

o Deceptive or misleading packaging and labeling. 

o Fraudulent products. 

• Filth, decomposition, foreign objects, microbial or chemical contamination

• Animal/plant/insect material. 

• Off appearance, off odor, or off taste. 

• Glass, metal, plastic or other foreign objects. 

• Bacteria, yeasts, molds, or fungi. 

• Pesticides, industrial, or other chemicals. 

• Defective products

o Sub potency or super potency. 

o Particulate matter. 

o Failure to operate as intended. 

• Adverse reactions

o Allergic reactions. 

o Expected reactions. 

o Birth defects and problem pregnancies. 

o Death. 

• Tampering

Complaints are received from various sources, including consumers, other government agencies, 

Congress on behalf of their constituents, trade associations, etc. SOP-000544 – Consumer Complaint

Procedure describes the receipt and processing of consumer complaints in detail.

The FDA Office of Emergency Management/Office of Emergency Operations (OEM/OEO), 1 (866) 

300-4374 and Emergency.Operations@fda.hhs.gov, must be notified immediately of all significant 

injury, illness, and suspected tampering complaints. OEM/OEO must also be notified of all 

complaints regarding infant formula/baby food. Advise OEM/OEO of the status of all such follow-up 

investigations. 

As unique situations arise, OEM may provide guidance concerning the type of follow-up to be made.

Note: Link to SOP-000544 is only available to ORA users on the FDA intranet. The link is: 

http://qmis.fda.gov/mc/Main/MASTERControl/vault/view_pdf.cfm?ui=062321012030&infocardID=7

QYTPC6FZFEZBO7GPP. Users who need a copy of the SOP outside FDA should use the Freedom of 

Information Process described in Section 8.1.3 to get a copy of the SOP.

 

8.1.5.7.1 - Types of Complaints

8.1.5.7.1.1 - Injury/Illness Complaints

A complaint indicating a serious injury, illness, hospitalization, or death requires immediate 

reaction. It will most likely require immediate investigation. 
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There are additional considerations with injury/illness complaints. The prior medical history 

of the complainant may provide indications regarding allergies, drug side effects or drugfood/drug-drug interactions which may be responsible for the illness or injury. Medical 

verification should be sought in these situations. 

8.1.5.7.1.2 - Non-Injury/Illness Complaints

Generally, these do not require immediate follow-up at the consumer level. Follow-up may 

include examining the parent lot, referral to another FDA division, state, or local agency, or 

deferral until the next regularly scheduled inspection. Examples include mold in beverages, 

obvious filth or insects in canned goods, etc. It may be possible that adequate investigation 

would be contacting the dealer, advising them of the nature of the complaint and 

requesting notification of any action taken. Non-injury/illness complaints do not need to be 

reported to the OEM/OEO unless product tampering is suspected, or the product is a baby 

food or infant formula. 

8.1.5.7.2 - Sources of Complaints – Who provides us with complaints? 

8.1.5.7.2.1 - Consumer

Consumers contacting field offices with complaints of injury or illness should receive a 

prompt, courteous response and assurance that their complaints will receive appropriate 

consideration. (See SOP-000544 – Consumer Complaint Procedure.) As the procedure 

describes, if the complainant cannot reach the complaint line, be sure to obtain all pertinent 

information (see SOP-00054 step 6.1.1 C). You cannot rely on consumers responding to 

follow-up calls or providing additional information later. 

8.1.5.7.2.2 - Industry

An industry official who contacts the field offices with complaints should receive a prompt 

and courteous response and consideration. Industry complaints should be treated in the 

same manner as consumer complaints. 

8.1.5.7.2.3 - Confidential Informant

A Confidential Informant is an individual who provides non-public information about an 

FDA-regulated entity/product, alleging potential violation(s) of federal law, or an illicit or 

unsafe product or activity, and who requests anonymity.  

 

Note: This definition does not apply to how OCI establishes and uses confidential informants 

in criminal investigations. For such purposes, OCI follows the definition of “confidential 

informant” as outlined in applicable U.S. Department of Justice (DOJ) policies and 

guidelines. It is important to avoid the disclosure of a confidential informant to a firm. The 

investigator conducting the investigation or inspection should not disclose the 

complainant’s information or report the information in the EIR. The complaint itself should 

be treated in the same manner as consumer complaints. 
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To maintain confidentiality, a memorandum regarding confidential information should be 

submitted as a separate operation, linked to the original report or submitted as an 

attachment to the EIR. There may be times when the report may be discussed in the EIR but, 

it will not disclose the source of the information. Discuss with your supervisor before 

including information about a confidential source complaint in the EIR. 

8.1.5.7.2.4 - Whistleblower

A whistleblower is a person, usually an employee or ex-employee, who discloses 

information or activity within a private, public, or government organization that is deemed 

illegal, illicit, unsafe, or a waste, fraud, or abuse of taxpayer funds. The complaint itself 

should be treated in the same manner as consumer complaints. It is important in these 

types of complaints that the identity of the whistleblower is not disclosed. The investigator 

should follow the same protocol as dictated in the Confidential Informant section above by 

not disclosing the complainant’s information or reporting the information in the EIR or any 

format where the information could possibly be released under the Freedom of Information 

Act. 

8.1.5.8 - Disaster/Emergency Response – How do we protect the consumer 

during a disaster or emergency?

The objective of FDA investigations in the aftermath of disasters is to determine whether or not 

foods, drugs including biologics, cosmetics, and devices affected by the catastrophe are safe for 

human and animal use; and if not, to effectively have them removed from commerce.

In disaster operations, FDA may assist state, local, and other federal agencies in removing 

contaminated or unfit merchandise from the market.

State and local officials usually assume direct responsibility for facilities and products under their 

jurisdiction, as their laws and regulations can be immediately invoked; however, FDA assistance is 

sometimes requested. Based on the size and scale of the disaster, FDA may receive an official 

request for assistance through FEMA, FDA/state Rapid Response Teams, or ad hoc through 

traditional state contacts. 

If contacted by emergency response personnel for follow-up assignments, please work with your 

supervisor to engage district Emergency Response Coordinator (ERC) for further coordination.

8.1.5.8.1 - Preparedness

Disaster preparedness is the first step to ensure personal safety and response efficiency. 

Measures taken to prepare for and reduce the effects of disasters both personally and 

professionally are crucial before an incident occurs.

It is recommended as a preparedness measure that you familiarize yourself with your 

local Continuity of Operations Plan (COOP). COOP is the initiative that ensures that federal 

government departments and agencies can continue operation of their essential functions 

under a broad range of circumstances including all-hazard emergencies, natural, man-made, and 
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technological threats, and national security emergencies. Today's threat environment makes 

COOP planning even more critical. Your local COOP will alert you to likely disasters for your 

geographic area.

Preparedness Resources:

FDA’s Emergency Operations Plan

(http://inside.fda.gov:9003/PolicyProcedures/SOPsbyProgram/EmergencyResponse/ucm381

277.htm) 

FEMA Preparedness (www.Ready.gov) 

8.1.5.8.2 - Safety

ORA considers the safety of staff to be of the utmost importance. 

In a disaster or pending disaster the personal protection of yourself and your family is 

your primary concern. Provide for your own safety as you perform your assigned FDA 

duties in a disaster area. Inoculations and protective clothing should be considered. 

See Chapter S-Safety. Particularly S.8.1 - General Preventive and Protective Measures, 

https://fda.sharepoint.com/sites/insideFDA-EmployeeResources/SitePages/OccupationalHealth-Services.aspx, S.17.2 -Immunizations, and S.9- PPE.

Disasters produce dangerous situations (e.g., high water, escaping gases, fallen electrical lines, 

damaged buildings, falling rubble, etc.), so care and extra safety precautions must be observed. 

A Personal Safety Plan may be developed when dealing with disaster situations. 

Be aware of hazards you may encounter while traveling in an affected zone such as power 

outages, damaged or impassable roads, and a lack of available supplies in the area.

Personal Protective Equipment (PPE) should be considered where appropriate. For example, 

appropriately fit-tested respirators such as N95 masks should be worn where there is a risk of 

inhaling pathogens. Each situation requires a careful evaluation and determination of effective 

PPE. Your supporting industrial hygienist should be consulted for guidance.

Safety Resources:

• DFI Field Alert #16

(http://inside.fda.gov:9003/downloads/policyprocedures/guidanceregulations/fiel

dinvestigations/ucm010162.doc) 

• ORA Safety Contacts

(http://inside.fda.gov:9003/ORA/Offices/OORS/Safety/default.htm) 

• ORA Radiation and Laser Safety Resources

(http://inside.fda.gov:9003/ora/offices/oors/safety/ucm655438.htm) 

 
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8.1.5.8.3 - Response 

CAUTION: Although procedures in this subchapter do not cover disasters resulting from 

a radiological event (presence or release of radioactive materials), it is possible you 

may discover products suspected of contamination by radioactive materials in the 

disaster area. If you suspect the presence of radioactive materials, take no action on 

the materials yourself, but have the area cordoned off at once. Notify the command 

official (official in charge) and immediately contact your IMT or supervisor, as applicable, to alert 

the radiological health representative and the state radiation control agency. Follow their 

instructions.

8.1.5.8.3.1 - Use of Incident Command System (ICS)

During some disasters, FDA may implement an Incident Command System (ICS) for 

response. ICS is a standardized approach to managing incidents at the on-scene level. It is 

the combination of procedures, personnel, facilities, equipment, and communications 

operating within a common organizational structure. ICS is scalable and flexible and can be 

used for small, as well as large and complex, incidents and planned events. 

As a CSO, you will typically be assigned under the Operations Section of the Incident 

Management Team (IMT). All operations you conduct, and your reporting structure will be 

provided by the IMT and shared via an Incident Action Plan (IAP). An IAP contains the 

incident objectives, the overall strategy for managing an incident, personal safety guidance, 

a comprehensive listing of the tactics, resources, and support needed to accomplish the 

objectives. (Note: Some CSOs with ICS position specific training may serve in a leadership 

role on the IMT.) 

While serving on an IMT, your reporting will be to your team leader and not to your 

supervisor. The IMT will provide specific guidance for reporting. Your activities will be 

reported through the IMT and not through normal channels. Reporting may vary depending 

on the incident and its objectives. You will not be following reporting guidance later in this 

chapter.

8.1.5.8.3.2 - Management of Disasters without ICS

Specific investigation assignments should come from your supervisor and reporting will be 

through the normal means, unless directed otherwise.

Response Resources:

• Disaster Response Flow Diagram (DRFD) package (Exhibit 8-9)

• Incident Management Handbook (IMH)

(http://inside.fda.gov:9003/downloads/policyprocedures/sopsbyprogram/emerge

ncyresponse/ucm391230.pdf) 

• Emergency Operations Plan (EOP)

(http://inside.fda.gov:9003/downloads/PolicyProcedures/SOPsbyProgram/Emerge

ncyResponse/UCM228297.pdf) 

• Homeland Security Presidential Directive 5 

(https://www.dhs.gov/publication/homeland-security-presidential-directive-5)
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8.1.5.8.4 - Disaster Types

The types of natural and man-made disasters that affect FDA operations are:

8.1.5.8.4.1 - Floods

All flood water, regardless of its source, must be considered a polluting medium because of 

overflowing sewers, outhouses, decomposing livestock, street run-off water, etc.

Depending on the extent of the flood, first determine the locations of the major stocks of 

regulated products. Food and drugs will normally receive first priority. As stocks of goods 

are located, rapidly survey the extent of damage, then concentrate on affected materials. 

Use your camera extensively. Examine the walls of buildings, storage areas, and the top and 

sides of stacked or tiered goods for flood water residue, debris, and a well-defined highwater mark. Finished products, ingredients, and containers stacked above this line are still 

of concern because other problems probably exist (e.g., vermin defilement, failure of 

refrigeration, thawing of frozen items, etc.).

Any suspect material should be embargoed by local officials or held pending final 

disposition. Management is usually cooperative and willing to do things it may not normally 

do to get back to normal operations as quickly as possible. Cooperate with management but 

avoid hasty decisions.

Many products are quickly rendered unsuitable for human consumption by flood water.

Items such as bread, cakes, cookies, candies, bulk flour, sugar, bulk liquids, and similar items

not in jars or hermetically sealed containers can often be immediately hauled to disposable 

areas and destroyed.

Determine areas which have lost power. In facilities such as frozen food firms, and frozen or 

refrigerated warehouses, check the sites for length of down-power and condition of the 

products. If power is restored in time to avoid thawing, or prevent spoilage of refrigerated 

items, and products were not inundated, or otherwise affected, there is no need for further 

examination.

Even though flood waters may not have inundated the firm, the situation may have caused 

sewer and waste lines to backflush into basements and immediately drain out again. Debris 

or sewage particles along walls and on low floor surfaces or presence of sewage odors are 

evidence of backflushing.

Grain, cottonseed, soybeans, dried bean products, peanuts, and similar products may 

become flood damaged in terminal elevators, on farms, and in flat storage facilities. In 

addition to flood water contamination, molding products may develop mycotoxin 

contamination. Examine susceptible products and facilities for damage, inundation, and 

mold.

Rodent activity may increase in flooded areas as the vermin seek food and shelter. Be alert 

to rodent defilement on products.
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As lots of products are checked, embargoed, or released and the immediate situation 

returns to normal, firms will want to start operating. Prior to beginning operations, examine 

equipment and processing facilities for pollution and its aftermath. Plant operation must not 

be permitted unless proper cleanup and sanitizing is performed.

8.1.5.8.4.2 - Earthquakes

Extreme care must be exercised when working in earthquake areas. Do not enter 

severely damaged buildings.

Most damage from an earthquake comes from the aftershocks, falling debris, and 

resulting fires and flooding. Items under FDA jurisdiction are most likely to suffer physical 

damage, spoilage from lack of refrigeration, and/or fire and flood damage.

8.1.5.8.4.3 - Hurricanes and Tornadoes

Investigate following the guidance in Flooding Section above. In addition, examine products 

for evidence of physical damage caused by flying objects and crushing by debris. Physical 

damage to product containers may be extensive. Broken or leaking containers of materials 

such as chemicals, oils, fertilizers, etc., may have contaminated FDA-regulated products. See 

the Chemical Spills, Hazardous Waste Sites, Wrecks section below on chemical 

contamination from various sources.

8.1.5.8.4.4 - Chemical Spills, Hazardous Waste Sites, Wrecks

Chemical spills occurring on land or water can pose a serious threat to the environment and 

contaminate FDA-regulated products both directly and indirectly. See IOM 3.2.11 for 

information. 

In wrecks, the physical impact usually causes most damage. Toxic items in the same load 

may rupture and add to the contamination. In train wrecks, other railcars loaded with 

chemicals, oils, or other contaminating materials may rupture and contaminate food and 

drug products in otherwise undamaged cars. Removal of the wreckage may cause further 

physical damage or chemical contamination. Exposure to weather may also adversely affect 

the products.

Do not overlook the possibility that runoff of toxic chemicals from wrecked and ruptured 

cars may contaminate adjacent or nearby streams supplying water to downstream firms 

under FDA jurisdiction.

Hazardous waste sites also pose a hazard to the immediate environment and other locations 

off-site, if runoff contaminates nearby surface waters or, if leachate, contaminates ground 

water supplies.

8.1.5.8.4.5 - Fires, Explosions, Riots

FDA operations following these disasters are usually localized and do not normally involve 

many personnel or extended resources.
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Examine products for exposure to excessive heat, physical damage from flying objects, 

falling debris, and lack of refrigeration in down-power areas. Examine for water damage 

from firefighting activities and handle these as a flooding situation. Be alert for possible 

pollution from using non-potable water in firefighting.

Firefighting often involves use of chemicals. Examine products for residues from possible 

toxic fire extinguishing materials and question fire authorities regarding this issue.

In addition, chemical contamination in fire disasters can also be present from other sources, 

including:

1. Stored chemicals rupturing from heat or from impact of falling debris.

2. Spraying or leaking chemicals (liquid, powder, dust, granules) as damaged 

containers are being removed or salvaged from the fire area. 

3. Tracking of chemical material from contaminated areas to other areas by fire 

crews or others.

4. Burning or melting plastic containers, insulation, and other building materials.

5. Leaking fuels, storage batteries, anti-freeze, etc., from burning, damaged or 

overheated equipment.

6. Chemicals from melting or vaporizing electrical insulation and, in particular, 

cooling chemicals from leaking or exploding electrical transformers. Large 

commercial transformers are often directly involved in the fire area and may leak 

or explode from the heat, spreading toxic liquid chemicals (some transformer oils 

contain con-centrations of PCB) over a large area, even contaminating products 

in non-fire areas.

8.1.5.8.5 - Bioterrorism

The field was issued guidance from 2001 which includes the following:

If a bioterrorism act is suspected, FDA staff should not collect or accept samples from any local, 

state, or law enforcement agency as such actions will be coordinated by OCI and the FBI, as 

appropriate. If an FDA-regulated product is suspected in a tampering, please call OEM/OEO 

immediately. In the FBI/OCI determines the product is not suspect, OEM/OEO will issue further 

guidance to the division office.

Office of Emergency Operations / Office of Emergency Management (OEM/OEO) emergency 

operations 24-hour phone number is 1 (866) 300-4374. The e-mail is 

emergency.operations@fda.hhs.gov. 

For additional information see Guidance to the Field on Bioterrorism (10/17/2001)

(http://inside.fda.gov:9003/downloads/policyprocedures/guidanceregulations/fieldinvestigation

s/ucm023333.doc). (Note: This link is only available on the FDA Intranet site and cannot be 

accessed by individuals outside the FDA network. Requests can be made through the FOI process 

described in Section 8.1.3)

 
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8.1.5.8.6 - Embargoes

See IOM 3.3.1 and IOM 2.7.1. 

FDA does not have embargo authority, but does have administrative detention authority as 

specified in:

• The Federal Meat Inspection Act (https://www.fsis.usda.gov/policy/food-safetyacts/federal-meat-inspection-act) 

• The Poultry Products Inspection Act (https://www.fsis.usda.gov/policy/food-safetyacts/poultry-products-inspection-act) 

• The Egg Products Inspection Act (https://www.fsis.usda.gov/policy/food-safetyacts/egg-products-inspection-act

• Certain parts of the FD&C Act, namely Section 304(g) [21 U.S.C. 334(g)](g) [21 U.S.C. 

334(g)] for medical devices, drugs, and tobacco and Section 304(h) [21 U.S.C. 334(h)] for 

human and animal food 

States and local jurisdictions have embargo authority over FDA-regulated products. Embargoes 

are an effective tool for keeping adulterated and misbranded products from the consumer 

market. State and local embargoes can be employed immediately requiring the merchandise be 

held, destroyed, or reconditioned without time consuming delays. Some state and local 

embargo powers are limited to the length of time the product can be embargoed and a minimal 

quantity or value. In these cases, the use of federal administrative detention, injunction, and 

seizure action should still be considered. Your division will determine if embargoes are 

warranted and work with state or local authorities to obtain them.

8.1.5.8.7 - Field Operations

On-site inspectional and investigational activities will normally be conducted with other FDA 

personnel and state or local counterparts.

An assessment must first be made of the disaster area to determine the extent of damage, and 

the amounts and kinds of merchandise involved. This may be done by contacting local 

Emergency Operation Centers on current conditions, and from firm and mapping details of the 

impacted area provided by the OEO Geographic Information System (GIS). If an IMT is activated 

the Planning Section and Safety Officer will perform this assessment.

Whether operating within an IMT or not, once personnel are mobilized and assignments are 

issued, operational procedures will be similar, regardless of the type of disaster. Normally, you 

will search, identify, and investigate foods, drugs, devices, and cosmetics for actual or possible 

contamination and taking the necessary steps to preclude their use until they are released, 

reconditioned, or destroyed.

CAUTION: Although procedures in this subchapter do not cover disasters resulting from 

a radiological event (presence or release of radioactive materials), it is possible you 

may discover products suspected of contamination by radioactive materials in the 

disaster area. If you suspect the presence of radioactive materials, take no action on 

the materials yourself, but have the area cordoned off at once. Notify the command 
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official (official in charge) and immediately contact your IMT or supervisor, as applicable, to alert 

the radiological health representative and the state radiation control agency. Follow their 

instructions.

When in doubt as to the condition of any materials affected, request holds or embargoes 

pending final outcome of further examinations. See Section 8.1.5.8.6.

8.1.5.8.8 - Field Examination and Samples

Field examinations are an effective tool for determining adulteration or misbranding during 

disaster investigations. Judge the extent of field examination and sample collections necessary, 

based on the nature and magnitude of the disaster.

In major catastrophes, large numbers of samples may not be necessary because of obvious 

visible contamination and the emergency disposition powers invoked by state and local officials. 

In minor local disasters, such as fires, riots, train wrecks, truck accidents, or shipwrecks, lots may 

be held pending outcome of examinations and extensive sampling may be required.

Field examinations should focus on obvious adulteration, such as physical damage to products 

or containers, or damage to labeling.

Examine bulk containers and their contents, including underground storage tanks. Examine 

material in rail cars, truck trailers, and storage silos. Be especially alert for rail car and trailer 

movement. These may quickly disappear, as clean-up crews arrive.

8.1.5.8.9 - Product Disposition

Lots under embargo, or voluntarily held pending examination or analysis, must be secured until 

the examination or analysis is completed, and a release decision is made. If the material can be 

released, it is returned to the owner.

Depending on the circumstances and the magnitude of the disaster, segregation, destruction, or 

reconditioning of affected goods may be accomplished in the immediate area or the materials 

may be moved to distant locations for further manipulation.

FDA normally opposes movement of affected goods since control of the lots is difficult. 

However, in cases of widespread disasters, reconditioning centers established in non-disaster

areas may be the most efficient way to handle the problem.

8.1.5.8.9.1 - Segregation 

The segregation process often creates a multitude of problems, especially when insurance 

claims agents and salvage firms become involved. You are not to segregate materials 

yourself. This is the responsibility of the owner or his agent. You should advise them what 

constitutes releasable conditions. After segregation, you may be instructed to advise them 

about product release based on your examination and/or laboratory results.
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8.1.5.8.9.2 - Destruction

It is not your responsibility to say how condemned products are to be destroyed. This is a 

concern of the owner and the state or local health agencies that condemned the products. 

FDA may be asked to aid in or recommend destruction methods. The most common 

destruction method is crushing and dumping in a land fill in approved areas. See IOM 2.6.1. 

Destruction methods usually are worked out with state or local officials. The final decision in 

major operations may be required of the command officials or higher headquarters, 

especially if the environmental impact is significant.

Control products to be destroyed and protect them from pilfering at destruction sites.

8.1.5.8.9.3 - Reconditioning

Affected products may often be reconditioned depending on the condition of the product, 

its container, type of product, intended use, and extent and type of contamination.

Any reconditioning must be closely supervised, with proper safeguards for product 

accountability. Control must be maintained over the complete operation, with proper 

disposition of the rejected portion and the reconditioning of the acceptable portion 

performed to the satisfaction of all health officials.

Certain food products which cannot be salvaged for human or animal use might be of use in 

non-food or non-feed industries. However, these must be denatured to render them unfit 

for food or feed use. Firms must account for the amounts of product denatured, to whom it 

was sold, and the final use of the product. Examination of the product at its final destination 

and/or a spot check may be required to assure it is utilized in non-food or non-feed 

products. Reconditioning plans should be reviewed by the division’s Compliance Branch in 

consultation with the appropriate center or by the IMT if ICS is being used for the incident.

It is your responsibility to assure the firm is following the reconditioning plan and that no 

product is diverted from the plan.

8.1.5.8.9.4 - Relabeling

Relabeling may be the only reconditioning required if damage is solely to the label and all 

the following conditions are met:

• The new label contains all mandatory information, is not misleading in any way, 

and conforms with the FD&C Act in all other aspects.

• Label codes are carried over to the new label.

• The product is not contaminated; and

• The container has its original integrity.

8.1.5.9 - Counterfeiting and Tampering

8.1.5.9.1 - Reporting Contacts

All reports of counterfeiting, tampering, or tampering threats must be immediately reported to 

the Office of Criminal Investigations (OCI) headquarters office, Special Agent in Charge-
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Headquarters Operations (SAIC-HQS OPS) at 240-276-9500 and the Office of Emergency

Management (OEM)/Office of Emergency Operations (OEO) at 1 (866) 300-4374 (24 hours). 

If the complaint or report involves a United States Department of Agriculture (USDA) regulated 

product, the district office should report it directly to the USDA and notify OCI, SAIC-HQS OPS, 

and OEM/OEO immediately. Notification of OCI may be done online at OCI’s Report Suspect 

Criminal Activity website: (https://www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm). 

OEM/OEO can be notified by e-mail at emergency.operations@fda.hhs.gov and by phone 24 

hours a day at 1 (866) 300-4374. 

Do not conduct any investigation into these reports unless you have been directed to do so by 

management following their meeting with OCI. 

8.1.5.9.2 - OEM / OEO Responsibility

OEO/OEM is the focal point for communications; especially in those counterfeiting/tampering

cases where regional/national coverage is necessary. Alert OEM immediately to all suspected or 

confirmed counterfeiting/tampering incidents, whether or not there is an injury/illness involved, 

especially if media attention will be initiated by any source.

8.1.5.9.3 - Coordination with Other Government Agencies

The Federal Bureau of Investigations (FBI) and the USDA share enforcement of the Federal AntiTampering Act (FATA) with FDA as described below:

1. FBI Responsibility - The FBI has concurrent jurisdiction under the FATA over products 

regulated by FDA. The FDA understands the FBI's primary interest in the FATA matters 

will be to investigate; particularly, those cases which involve a serious threat to human 

life or a death. SAIC-HQS OPS or the local OCI field office will coordinate all referrals to 

the FBI in accordance with agency policy.

2. USDA Responsibility - The USDA will investigate and interact with the FBI on 

counterfeiting/tampering of products regulated by USDA. If a counterfeiting/tampering 

complaint or report is made to an FDA district office and involves a USDA-regulated 

product, the district office should report it directly to the USDA and notify OCI, SAICHQS OPS, and OEM/OEO immediately. Notification of OCI may be done online at OCI’s 

Report Suspect Criminal Activity website: 

(https://www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm). 

Isolated incidents of counterfeiting/tampering not investigated by OCI and not meeting the 

criteria for FBI or USDA follow-up, may be referred to the appropriate state or local 

investigative agencies, as outlined in section 8.1.5.9.4. The appropriate center should be 

consulted in these cases. Assistance should be provided to cooperating officials as necessary or 

where requested.
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8.1.5.9.4 - Authority & Responsibility

FDA is authorized to investigate reported counterfeiting/tampering of FDA-regulated consumer 

products under the FATA, Title 18, USC, Section 1365 and Title 18, USC, Section 2320. See IOM 

Exhibit 8-1. In most cases, the authority for such investigations is also found in the FD&C Act.

OCI has the primary responsibility for all criminal investigations of 

counterfeiting/tampering/threat incidents of FDA regulated products. Given that responsibility, 

OCI field offices will coordinate responses to counterfeiting/tampering reports with the district 

offices they deem appropriate, to ensure initial investigative steps are taken in a timely and 

efficient manner.

In those incidents where OCI does not, or cannot, initiate a criminal investigation, 

they will inform the division of their decision and the division will determine the 

proper follow-up, which could include further investigation by the division or referral 

to local or state authorities. The division will keep OCI informed of their follow-up 

activities and any relevant changes in its status. Prior to initiation of any tampering

investigation, you and your supervisor should evaluate the situation from a personal safety 

perspective. You and your division management may also need to determine if a situational plan 

is warranted. Refer to IOM 5.2.1.2 - Personal Safety, and IOM 5.2.1.4 Situational Plan, for more 

information.

8.1.5.9.5 - Release of Information

During any investigation related to counterfeiting or tampering, no information should be 

released without management approval. If there are inquiries about the investigation, contact 

your supervisor.

8.1.5.9.6 - Investigation

The purpose of these investigations is to determine if counterfeiting/tampering has occurred; 

the seriousness of the problem; the quantity of affected products on the market; the source of 

the counterfeiting/tampering; and quick removal from consumers or commerce of any 

contaminated product. OCI will seek to identify and initiate criminal prosecution of those 

persons responsible for criminal activity associated with counterfeiting/tampering/threat 

incidents.

FDA will investigate reports of counterfeiting/tampering associated with FDA-regulated 

products. Priority will be given to reports of death, illness, injury, or a potential health hazard. 

Adhere to existing procedures and instructions as outlined in the IOM and RPM when 

conducting counterfeiting/tampering investigations, inspections, sample collections, special 

investigations, and related activities including interviews, record examination, direct 

observation, affidavits, etc.

8.1.5.9.7 - General Procedures

Counterfeiting/Tampering incidents historically have occurred in unpredictable forms and 

products. Standard operating procedures (SOPS), in most cases, will suffice for these 
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investigations. As events take place, specific instructions for some investigations may be 

provided by OCI headquarters and/or your division office. Expeditious resolution is important, 

especially when a health hazard may be involved.

Attempt to answer the following questions as rapidly as possible:

• Has counterfeiting/tampering occurred, or can the condition of the product be 

explained by other means?

• Is death, injury, or illness associated with the report and, if so, does it appear to be 

caused by the product counterfeiting/tampering? 

• Does the incident appear to be isolated or wide-spread?

• Is it likely other, similarly affected FDA-regulated products remain in distribution, and if 

so, what is the extent and magnitude of distribution?

• If the incident involves more than a single container, could counterfeiting/tampering

have occurred at the production facility or in the distribution chain rather than at retail? 

• Can specific persons or points in the distribution chain be identified as possibly causing 

the problem?

Be sure to coordinate your efforts with OCI SAIC/IOD HQS OPS and OEM/OEO. 

In many counterfeiting cases, ORA investigators and OCI agents conduct joint 

inspections/investigations at the distributors. It is the purpose of the ORA investigators to 

document receipt and distribution of counterfeit products and to discuss voluntary recall of 

those products. OCI agents will at the same time conduct their investigation into the knowledge 

and source of the counterfeit products. It is not your purpose to accompany the OCI agent 

during his/her investigation.

8.1.5.9.8 - Sampling

8.1.5.9.8.1 - Tampering Cases

Whenever a sample is collected for suspected tampering, you must collect an authentic 

sample of the same product. It should be from the same lot and code, if at all possible. The 

sample size for the authentic portion is at least six in-tact units. Follow normal sampling 

techniques; however, recognize that there may be forensic evidence available such as 

fingerprints and hair that can be lost if the sample is not handled properly.

The Forensic Chemistry Center should be contacted prior to sampling. They can give specific 

directions regarding sampling in each situation, especially related to the preservation of 

forensic evidence like fingerprints.

Samples should be packed to avoid movement of the product container within the

bag. Individual dosage units from previously opened containers can be protected 

by removing them from their container utilizing spoons or forceps. Secure them in 

separate containers so they do not rub or smear possible evidence. Further 

guidance can be found in the FBI "HANDBOOK OF FORENSIC SERVICES" 

(https://www.fbi.gov/file-repository/handbook-of-forensic-services-pdf.pdf/view). As a 
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precaution, rubber gloves may be worn inside of cotton gloves as protection against toxic or 

caustic substances.

Ship samples with extreme care to ensure their integrity. Thoroughly describe your sample 

and its characteristics on the collection report (C/R) to facilitate analysis. Include any 

descriptive terms used by individuals associated with the complaint. If special instructions to 

preserve fingerprints or for further handling are indicated, they should be noted on the C/R. 

If speed is imperative, consider hand delivery to the lab.

8.1.5.9.8.2 - Counterfeiting Cases

If sampling is indicated during an investigation of counterfeiting, follow the directions from 

OCI or the Forensic Chemistry Center regarding collection, packaging, and shipment of the 

sample. Authentic samples should only be collected when requested by OCI in consultation 

with FCC.

8.1.5.9.9 - Complainants

Some complaints about “foreign objects” may be tampering complaints. The complainant may 

state they found something in a product. You should be aware that any complaint investigation 

of foreign objects may become a tampering investigation.

Consumers are likely unaware of the provisions of the Federal Anti-Tampering Act (FATA). A 

general discussion of the FATA, its provisions for investigation, filing of false reports, and 

counterfeiting/tampering can be useful and informative to those individuals. Consumers are 

often unaware that merely filing a false report is a serious crime and once aware may rescind 

previous statements. In general, this would close an investigation, but you should discuss this 

with your supervisor.

Prior to concluding your interview of the complainant, obtain a signed affidavit attesting to the 

circumstances of the complaint, as directed by IOM 4.4.5. Include a statement in the affidavit 

similar to the following, "I have been informed of the provisions of the Federal Anti-Tampering

Act and also that the providing of false information to the federal government is illegal." It is 

permissible to pre-type this statement at the bottom of an affidavit, FDA 463a, and photocopy it 

before use if you have a large number of counterfeiting/tampering complaints to investigate.

8.1.5.9.10 - Continuance of Investigation

Some investigations may continue after the interview and sample collection from the consumer. 

If you are directed to continue the investigation at the retail, distribution, or manufacturing 

sites, obtain specific guidance from your management or OCI before proceeding. You may be 

conducting an inspection at a firm simultaneously with an OCI investigation. You should not 

disclose to the firm officials anything about an OCI investigation. 

8.1.5.9.11 - Refusals

All refusals encountered during counterfeiting/tampering investigations should be documented 

using existing procedures. Refusals of requests should be documented in detail. Assure the firm 
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is aware of the non-routine nature of the request. If a search warrant or other court order is 

necessary, OCI will lead or direct this part of the investigation. Report all refusals to the local OCI 

field office.

8.1.6 - General Investigative Techniques – What do I do during an 

investigation?

8.1.6.1 - Interviews 

An interview is a one-on-one structured conversation to obtain accurate, reliable information. To 

gain the most facts and information, be prepared and conduct the interview methodically with a set 

purpose. 

8.1.6.1.1 - Preparation

Interviews may be conducted in various agreed upon meeting places. Choose a non-threating 

place for the interview, such as a conference room or private office free from distractions or 

interruptions. Silence your phone to avoid incoming calls. If possible, conduct the interview away 

from the person’s normal area of business. If interviewing a consumer at their home, try to 

interview them in an area of their home that has the least distractions. If possible, conduct the 

interview sitting directly across from the interviewee.

Begin by researching your topic. Set a specific purpose and objectives for what you want to learn 

during the interview. 

8.1.6.1.2 - The Interview

• Set the tone. In most cases, you may tell the interviewee what they can expect. Start out 

with generic or easy-to-answer questions to establish a baseline and to put the subject at 

ease. 

• Avoid asking leading questions. Ask open-ended questions that encourage the interviewee 

to talk and provide a full answer rather than a “yes” or “no” (e.g., Tell me about..., How did 

you..., Why was this..., etc.) Avoid combining more than one idea into the same question. 

Frame the question to generate an answer one fact at a time. Avoid questions that are 

accusatory or that trigger a defensive response. ‘Yes’ and ‘no’ questions may be used at the 

end of the interview to affirm facts. 

• Keep an open mind. 

• Do not express your opinions, thoughts, and your own conclusions about the situation or 

what the interviewee says. You are trying to learn information and facts from the 

interviewee so avoid being too familiar with the topic in your responses. Set aside any 

potential biases while conducting the interview.

• Take detailed notes or have another CSO present to take notes. This is extremely helpful 

since you are focused on the objectivity of the interview. If taking notes makes the 

interviewee uncomfortable or hinders the interview, you may take notes immediately after 

the interview and identify the time between the interview and your notetaking and explain 

the circumstances for not taking contemporaneous notes during the interview. Only use 

quotes (“...”) if you are certain they are exact. It is a good practice to read a quote back to 

the interviewee to confirm its accuracy. 
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• Pay attention to the subject’s verbal and non-verbal communication. 

• Ask for clarification and more detail if responses are not clear to you during the interview. 

Repeat answers back to the subject to ensure you heard the information correctly. Ask if 

documents exist and to support any part of the interviewee’s story. Collect any available 

relevant documents. 

• Follow-up questions may help establish additional facts. If your questions are avoided or 

the answers seem evasive, try rephrasing the question and ask it again. You may also 

change topics and return to an issue later. 

• Allow the interviewee enough time to answer your questions and avoid interrupting them. 

Sometimes silence can be a tool to prompt further explanation or reaction. Before 

concluding the interview, ask the subject if there is anything else they would like to provide 

or discuss. Ensure that the interviewee has your contact information in case they recall any 

more material information later. 

• Interviews and discussions with complainants where tampering is suspected or alleged,

should include a discussion of the Federal Anti-Tampering Act (Exhibit 8-14). This discussion 

needs to be documented in the investigation report/memo. See IOM 4.4.3.3

8.1.6.1.3 - Safety

Developing a Situational Safety Plan may also be required. Refer to IOM 5.3.5.4.2 

In preparation for any consumer complaint interviews, you should take your personal 

safety into consideration. Refer to IOM 5.2.1.2 for more information.

8.1.6.1.4 - Basic Information to Obtain

Obtain an accurate and complete description of the product, e.g., brand name, product name, 

flavor or variety, how packaged, storage conditions required (i.e., refrigerated or shelf stable) etc. 

Refer to Consumer Complaint Procedure (SOP-000544) Section 6.1.1 C.

It is important to accurately determine the sequence of events leading up to the complaint.

You cannot rely on consumers responding to follow-up calls or providing additional information 

later.

8.1.6.2 - Medical Records

In investigating complaints where the complainant was seen by a health professional, contact the 

health professional concerning the nature of the alleged illness/injury, and the relationship to the 

product. You may occasionally find the complainant has not mentioned the product to the health 

professional as a potential cause of the illness or injury. Use judgment as to the usefulness of 

collecting medical records. Examples of medical records to collect include: Admission History and 

Physical; Emergency Room/Clinic Record of the event if patient not admitted; Discharge Summary; 

Autopsy Report; and Death Certificate. See also IOM 5.3.8.6. 

If collection of medical records is necessary, use the letter template found in Exhibit 8-2. It may be 

necessary to use multiple letters if medical records are at different locations. If you encounter 
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resistance from the medical professionals in providing records, you may refer them to 45 CFR 

164.512(b) which explains the exemptions allowing FDA access to the medical records.

FDA is exempt from the HIPAA Privacy Rule as a public health authority. If a situation arises in which 

information sharing is impeded by the belief that FDA lacks authority to receive this information, 

you may share the language below during disease outbreak investigations or consumer complaint

follow-up. References are provided for further information. 

“The Health Insurance Portability and Accountability Act (HIPAA), Standards for Privacy of 

Individually Identifiable Health Information; Final Rule (Privacy Rule) permits disclosure of privacy 

information without a written patient authorization for specific public health purposes. Specifically, 

the Privacy Rule permits covered entities to disclose this type of information to ‘a public health 

authority that is authorized by law to collect or receive such information for the purpose of 

preventing or controlling disease, injury or disability, including...the conduct of...public health 

investigations’

1

. Per the Privacy Rule, ‘public health authority means an agency or authority of the 

United States...including the employees or agents of such public agency...that is responsible for public 

health matters as part of its official mandate’

2

. FDA, as a public health authority responsible for 

ensuring the public health and safety with regards to FDA-regulated products, meets this definition. 

Our authority to receive information related to FDA-regulated products comes from the Federal 

Food, Drug and Cosmetic Act (FD&C Act), the Public Health Service Act, and regulations issued under 

those authorities. 

“The Privacy Rule permits covered entities to disclose protected health information (including 

personal privacy information) directly to the FDA for certain public health activities and purposes, 

provided that the disclosure is limited to the minimum amount necessary. During FDA follow-up to 

reports of illnesses potentially associated with FDA-regulated products, access to personal privacy 

information including names and contact information is necessary in order to ensure timely followup and, potentially, removal of implicated products from commerce. FDA is also responsible for 

safeguarding personal privacy information released to us according to the Freedom of Information 

Act and the Privacy Act3 and our information disclosure regulations4

, and is obligated to comply with 

all applicable protections, procedures and legal requirements against the unauthorized disclosure of 

this information. 

“Consequently, personal privacy information including case names and contact information should 

be shared by state and local health departments with FDA authorities during an investigation of 

potentially adulterated FDA-regulated products, including illness outbreaks potentially associated 

1 45 CFR 164.512, from the Privacy Rule, available at https://www.law.cornell.edu/cfr/text/45/164.512

2 45 CFR 164.501, also from the Privacy Rule, available at https://www.law.cornell.edu/cfr/text/45/164.501

3 5 USC 552, 5 USC 552a, from The Privacy Act of 1974 5 USC 552a (as amended), available at

https://www.law.cornell.edu/uscode/text/5/552 and https://www.law.cornell.edu/uscode/text/5/552a

4 21 CFR Parts 20 and 21, from FDA information disclosure regulations 21 CFR Parts 20 and 21, available at 

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=20
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with FDA-regulated foods. Prompt information sharing speeds the agency’s investigation and can 

prevent additional illnesses and/or deaths due to an adulterated FDA-regulated product.”

If the investigation is related to an outbreak/illness and the Office of Emergency Operations or 

Coordinated Outbreak Response and Evaluation is coordinating the incident and a medical officer 

has been assigned to the investigation it is preferred that the CSO, with supervisory concurrence 

communicates with the medical officer about the documents to collect prior to the collection. In the 

absence of a medical officer being assigned or available, the CSO in collaboration with the 

supervisor, should collect medical records most relevant to the incident. Once collected, the Office 

of Emergency Operations or CORE if involved, or the supervisor in consultation with their 

management should identify a medical officer to review the records.

The records containing personal identifiable information (PII) and medical information need to be 

protected. All medical information sent to the medical officer electronically needs to be encrypted.

Hardcopy records shipped to the medical officer need to include shipment tracking information and 

request signature upon receipt. The medical records should be addressed to the attention of the 

specific medical officer who will be conducting the review. 

Any hard copy medical records in the possession of the CSO after sending to the medical officer or 

returned by the medical officer, should be placed in a sealed envelope, identified to contain PII and 

medical information and filed with the investigation memo.

When collecting medical records from a Department of Defense (DoD) medical facility, identify 

yourself to the commanding officer of the facility or representative and request authorization to 

examine and copy records. Please note that DoD Directive 6040.2, Release of Information from 

Medical Records authorizing release of medical information to government agencies, has been 

rescinded by DoD; if the representative of the facility requests a letter authorizing release, use the 

same letter as above. 

If the hospital does not accept the FDA letter for Authorization for Medical Records Disclosure, 

obtain and complete the one the facility provides.

Collect all medical records pertinent to the investigation. See IOM 5.11.5. 

References are available at: https://www.law.cornell.edu/cfr/text/45/164.512 and 

https://www.cdc.gov/mmwr/preview/mmwrhtml/m2e411a3.htm. 

8.1.6.3 - Sample Collection

Chapter 4 covers general sample collection methods and authority. In general, collection of samples 

during an investigation will be directed by the assignment or in discussion with your supervisor. 

Opened containers of product are rarely sampled. 

Prior to initiating sample collection, you may consider contacting the home division of the 

manufacturing plant. They may be aware of an existing issue related to the product and problem. 

Samples should be collected immediately, while they are available. 
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When a consumer portion is collected, intact containers of products of the same lot should be 

collected from the retail and wholesale levels if available. When collecting samples at retail or 

wholesale, ask if the firm is aware of any other complaints concerning the product. Refer to IOM

4.3.4.1 for additional information concerning collection of consumer portions. Maintain the 

confidentiality of the complainant. If the distributor inquires about holding or recalling the product, 

refer them to your supervisor. 

 

8.1.6.4 - Internet Investigations

The internet can provide useful information when conducting many types of investigations, 

including obtaining basic background information. Often you can use your government issued 

computer or cell phone for basic firm information (e.g., hours of operation, key personnel, location, 

directions, etc.). In these cases, you are using the internet as a tool to assist as you determine where 

and how to collect information and conduct your investigation.

When conducting specific internet investigations and documenting evidence online, refer to 

Introduction to Internet Investigations

(http://inside.fda.gov:9003/ORA/Offices/OEIO/Enforcement/ucm560967.htm). 

Note: This website is on the FDA Intranet and not accessible outside of the FDA Network. 

8.1.7 - Locations for Investigations – Where could you conduct an 

investigation?

Some examples of locations for investigations include:

Retail establishments. 

A consumer’s residence. 

Other government agencies. 

Location agreed upon with a complainant. 

Hospitals/physicians’ offices. 

Online. 

Depending on the circumstances involved, an investigation can be performed at almost any location. 

8.1.8 - Internal and External Organizations Involved - Who else will I 

encounter during an investigation? Why are they involved?

The agency works cooperatively with many outside organizations, primarily other federal government 

agencies and state, local, tribal and territorial (SLTT) authorities. Internally, you may work with 

individuals from ORA headquarters, OCI, other programmatic divisions or center employees. Some of 

these organizations become involved due to contractual obligation, statutory obligation, request for 

expertise, or memorandum of understanding (MOU). Chapter 3 of the IOM provides information about 

major organizations that FDA interacts with, both federal and state.
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8.1.8.1 - Interagency Referral

One of FDA's functions is to assist SLTT and other federal agencies in conducting investigations, 

collecting samples, and conducting plant inspections. If you find information during the course of an 

investigation that may be relevant to another federal agency, a referral request can be made by 

filling out an online form https:/www.accessdata.fda.gov/scripts/IRF/. 

Primary regulatory authority may belong to FDA or another agency. It is important to be aware of 

which organization has primary regulatory authority during an investigation. 

For Grade A Milk products, raw molluscan shellfish, and retail food operations, within ORA, the 

Office of State Cooperative Programs (OSCP) has lead responsibility. For these cooperative 

programs, the state has primary authority for investigations. FDA often accompanies and assists 

states during investigations through the Office of State Cooperative Programs. If your investigation 

involves Grade A Milk or Milk Products, raw molluscan shellfish, or retail food operations, contact 

the Office of State Cooperative Programs before investigating. 

8.1.8.2 - Intra-agency/Cross-Program

Outside of ORA, you may be involved other components of FDA. FDA staff work closely with one 

another to ensure the safety, efficacy, and security of FDA-regulated products. FDA 

functions are organized into the following:

• The Office of Foods and Veterinary Medicine (OFVM) provides oversight of FDA’s food and 

feed programs as well as leads the implementation of the FDA Food Safety Modernization 

Act of 2011 (FSMA). OFVM includes the Center for Veterinary Medicine (CVM) and the 

Center for Food Safety and Applied Nutrition (CFSAN) which includes the Coordinated 

Outbreak Response and Evaluation (CORE) Network.

• The Office of Medical Products and Tobacco (OMPT) provides high-level coordination and 

leadership across the centers for drugs, biologics, medical devices, and tobacco products. 

This office also oversees special medical programs.

• The Office of Global Operations (OGO) is focused on globalization and import safety of 

food and drug production and supply. OGO provides direction and support to ORA and the 

Office of International Programs (OIP).

8.1.9 - General Investigation Reporting - How do I report my investigation? 

How do I get credit for the time I spent on it?

Reporting an investigation is almost always done using a memorandum (see Exhibit 8-3) and captured as 

an operation in eNSpect (explained in more detail below). The format of the investigation memo is not 

as defined in sections as an establishment inspection report (EIR). As a general guideline you can first 

summarize why or give the reason for the investigation, what was covered, and briefly state the 

findings. After this, you can go into detail about how you conducted the investigation and what you 

found. Reporting the course of your investigation and your findings chronologically works in most 

situations. For long narratives, using headings will make it easier for the reader to follow your reporting. 
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Some types of investigations have forms that need to be completed in addition to the narrative within 

the memo. For example, FDA Form 3623, the Farm Investigation Questionnaire (FIQ), must be 

completed for all farm investigations.

For import specific investigations see IOM 6.1.3.8.

8.1.9.1 - Entering investigation operations in eNSpect 

eNSpect is used to capture information about the assignment, the establishment, and the 

investigation. Investigation operations are reported in eNSpect as either a Domestic Investigation 

(OP13) or Foreign Investigation (OP15). General information on how to complete these operations 

in eNSpect field client are provided below. (For complete instructions, refer to the eNSpect 

Resources Site for the current eNSpect User Guide and eNSpect training.) The “Investigation” tab 

in eNSpect includes the “Details,” “Time & Coverage,” and “Endorsement” pages. 

The “Endorsement” page has three sections: Endorsement, Attachments, and Supervisor Feedback. 

Attachments, such as the investigation memo, are uploaded to support your findings under the 

“Attachments” section of the endorsement page. All three sub-sections must be completed, and 

each has a maximum of 4000 characters per text box. The narrative entered in these sub-sections 

will depend on several factors (e.g., program/division, type of investigation, assignment). If the 

character limit prevents you from describing all relevant facts, an investigation memo should be 

prepared and uploaded under the “Attachments” section. If the space is adequate to report your 

investigation, you may not need to prepare a memo. For example, reporting OEI improvement 

activities and firms determined to be out of business (OOB) are two situations where a memo 

usually is not necessary. However, this can also depend on your program and/or division 

procedures. Programs of divisions may require a memo for all investigations. Consult with your 

supervisor if you are unsure whether a memo is required for the investigation.

Your supervisor or other designated individual will review and endorse the investigation report

(OP13 or OP15) in eNSpect. An inspection (OP11 and OP12) can be converted to an investigation 

(OP15 and OP13, respectively) in eNSpect when you were unable to complete the inspection (often 

referred to as a “washout”). Obtain supervisory concurrence before converting an inspection to an 

investigation due to a washout. For example, your supervisor may want you to hold onto an 

inspection assignment and inspect a seasonal firm later in the year rather than converting the 

inspection to an investigation as a washout. 

Reasons to convert an inspection to a washout include the following: Out of Business (OOB); Not 

Official Establishment Inventory (NOE); Inactive (INA); Seasonal (SEA); Operational but not an FDA 

obligation (OPR); Pre-Production (PRE-PROD), and Firm does not meet assignment criteria (OPR). 

The information reported in your investigation, especially the reason for the investigation, may be 

helpful to future investigators. If the investigation finds further action is recommended, do not 

convert the associated inspection assignment to a “washout” in eNSpect. Report the operation 

using an ad-hoc eNSpect investigation (OP13 or OP15). Do not return the associated inspection 

operation (OP12 or OP11) to FACTS for conversion to an investigation. An example of a further 

action would be a request for Import Alert because of an inspection refusal in a foreign country.
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8.1.9.2 - Investigation memo: format, content, endorsement, and routing

Exhibit 8-15 demonstrates the general format of a memorandum of investigation (investigation 

memo), which includes the originating division/office; responsible firm; FDA Establishment

Inventory (FEI); to/from; date; and subject. When writing an investigation memo, consider the 

following:

• Document all pertinent information (e.g., who, what, when, where, why). At a minimum, 

the investigation memo should contain the following information: the reason for the 

investigation; background and history, if any; findings; and recommendations.

• Provide details of how you conducted the investigation and describe pertinent data, 

references, attachments, etc.

• Headings may be used if it contributes to presenting your report in a clear, logical, and 

concise manner.

• Routing for the memorandum should be included. Consult with your supervisor if unsure 

of the correct routing information to include. 

8.1.9.3 - Reporting complaints/follow-ups

Refer to SOP-000544, Consumer Complaint Procedure, in the Quality Management Information 

System (QMiS) for detailed instructions on the screening, evaluation, monitoring and investigation 

of consumer complaints of FDA-regulated products received by and/or submitted to ORA personnel.

If you conduct an inspection to follow-up on a complaint, any findings related to the complaint

should be documented in the Establishment Inspection Report or in one of the following ways for an 

OP13/OP15, if not involving confidential informants, whistleblowers, etc.,

If you conduct an inspection as above, but it involves a confidential informant or whistleblower,

follow directions for reporting provided in Consumer Complaint section related to Confidential 

Informant or Whistleblower.

Information contained in the investigation memo or sub-sections of the “Endorsement” section of 

eNSpect, should at a minimum include a general discussion of the complaints that were covered and 

the complaint number(s). The complaint numbers should be recorded in the endorsement of the 

OP13/OP15. In addition, consumer complaints are linked to these operations in eNSpect by entering 

the consumer complaint ID under the “Details” page in eNSpect.

The time spent on the consumer complaint follow-up should be reported in the eNSpect assignment 

(OP13 or OP15) under the appropriate complaint Program/Assignment Code (PAC) for any 

complaints covered during the investigation. Refer to the PAC Master List for the appropriate PAC.

If a sample is collected during a domestic consumer complaint follow-up investigation, the sample 

number is linked to the OP13 in eNSpect by entering the sample number under the “Details” page in 

eNSpect. In addition, an OP31 (Sample Collection) with a collection report containing all relevant 

information will be completed. If the primary response to the complaint is collection of a sample 

and no further investigation, no assignment (OP13 or Op12) is generally created for completion in 

eNSpect. In this case all relevant documents would be included with the OP31 collection report. If 

unsure of what operation to enter in eNSpect and/or FACTS, consult with your supervisor. 
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8.1.9.4 - Reporting information obtained from a confidential informant

During an investigation, inspection, or other operation, you may acquire information from a 

confidential informant. See IOM 5.2.9 for information on how to interview confidential informants 

and document information obtained from them. Information received from a confidential informant 

during an investigation should be captured in an investigation memo as an attachment to the 

OP13/OP15. See IOM 5.2.9.2 for suggestions on how to protect the identity of the confidential 

informant when writing your investigation memo. Information contained within an OP13/OP15 is 

outside the scope of FMD-145 (Release of the Establishment Inspection Report (EIR) and should be 

reviewed by FOIA personnel for appropriate action before release.

If during an inspection you interview a confidential informant or whistleblower, do not include any 

identifiable information in the EIR and prepare a separate memo of investigation to cover this part 

of the inspection. Enter as an OP 13 or OP 15. See 5.2.9.2.

8.1.9.5 - Reporting investigations conducted during disaster response

There is no prescribed format for narrative reporting of disaster operations. Consult with your 

supervisor as to your division's preference. If operations were conducted as an investigation, you 

will likely write an investigation memo to document the activities. The memo should briefly describe 

the onset of the disaster, its magnitude, and your activities. Include cooperation with officials, 

planning operations, and the logical sequence of your activities.

Your memo must contain exhibits consisting of photographs, diagrams, records, references to 

samples, and any other items necessary for proper presentation of the operation. Refer to RPM 

Chapter 8 “Emergency Procedures,” for guidance on reporting natural disasters and civil disorders. 

List amounts of materials or products destroyed and the method of destruction. Prepare charts and 

lists as necessary to provide documentation of all affected lots destroyed, reconditioned, or 

released. Include kinds and amounts of materials segregated, released, reconditioned, and 

destroyed and method of reconditioning and/or destruction. 

In situations where an ICS structure has been implemented, operations are reported through the 

IMT and use of ICS forms, situation reports, after-action reports, or other documents as appropriate 

to the operation. The IMT will direct you on reporting your time spent working on the operation. 

If a sample of an FDA-regulated product is collected as part of the disaster response under ICS, an 

OP31 (Sample Collection) with a collection report containing all relevant information will usually be 

completed. In this case, your time spent conducting the sample collection would be reported in 

FACTS as part of the OP31 and using the PAC appropriate for the assignment.
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8.2 - Human and Animal Food Investigations

8.2.1 - Coordination

The initial step in coordination of a human and animal food investigation is notification of the potential 

incident. Notification to FDA may be received from SLTT officials via the district ERC or divisional staff; 

consumer complaints or adverse event reporting portals; or from federal entities such as the Centers for 

Disease Control and Prevention (CDC) alerting the FDA of illness clusters. Regardless of the source, once 

a potential incident is identified, the district ERC (DERC) is the primary point of contact (POC) for 

coordination of the response at the field level. (See Communications SOP for ERCs)

If agency-level central coordination is needed, CORE or CVM will most often provide management of the 

incident based on whether human or animal foods are suspected. However, there are instances when 

food incidents may be coordinated by OEM or a CFSAN office based on the specific commodity and 

scope of incident. (See Exhibit 4 for the “Table Depicting Incident Coordination Body by Type of Incident.)

8.2.2 - Foodborne Illness Outbreak Investigations

8.2.2.1 - Cooperation with Other Agencies 

One of FDA's functions is to assist SLTT and other federal agencies in conducting investigations, 

collecting samples, and conducting firm inspections if warranted.

In addition to state and local health departments, the following federal agencies may also become 

involved in investigating foodborne disease outbreaks:

• Centers for Disease Control and Prevention (CDC)

• U.S. Department of Agriculture (USDA)

• Environmental Protection Agency (EPA)

CDC becomes involved in foodborne outbreaks when people in more than one state are sick with 

the same germ from contaminated food. Their role involves coordinating the epidemiologic 

investigation, including identifying illnesses. CDC works directly with CORE to provide 

epidemiological information to help identify a possible food vehicle and focus the scope of FDA’s 

investigation. During an outbreak, CORE and CDC coordinate with internal and external partners 

(including international governments) to help determine the outbreak source and prevent future 

illness.

USDA is responsible for investigating outbreaks involving meat and poultry products under their 

jurisdiction. Whenever a complaint is received involving any meat-containing product, including 

such items as soups, combination infant foods, frozen dinners, etc., evaluate the need to contact 

USDA. Most products containing red meat or poultry are regulated by USDA. The exceptions 

include:

• products containing meat from game animals, such as venison, rabbits, etc.

• meat-flavored instant noodles

• "pork and beans" (which contains only a small amount of pork fat and is regulated by FDA)

• Closed face sandwiches
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USDA-regulated products display on their labels a round "shield" with the USDA Establishment 

Number. Alternatively, the establishment number may be identified in the lot number. Red meat 

products under USDA jurisdiction will often contain the abbreviation "EST" followed by a one to 

four-digit number; poultry products under USDA jurisdiction will contain the letter "P" followed by 

a number. 

IOM 3.2.1 and 3.2.4.3 provide information for reporting suspected outbreaks to USDA and CDC. In 

addition, FDA and CDC have an agreement that FDA will be immediately advised whenever CDC 

ships botulism antitoxin anywhere in the United States or its possessions.

Whenever a water source is suspected as a likely origin of the agent of an illness outbreak, the EPA 

should be notified. For example, when investigating a foodborne outbreak on a vessel passenger 

conveyance, you may find the water used in food preparation to be from a land-based source or 

from an on-board water treatment plant. Both of these sources would fall under EPA jurisdiction. 

See IOM 3.2.11.

When two or more people get the same illness from the same contaminated food or drink, the 

event is called a foodborne illness outbreak. For more information related to foodborne illnesses, 

please refer to https://www.fda.gov/food/recalls-outbreaks-emergencies/outbreaks-foodborneillness

8.2.2.2 - Outbreaks on Foreign Flag Vessels

If a suspect outbreak involving a foreign flag vessel or a U.S. flag vessel with an international 

itinerary comes to your attention, report it to your supervisor and the district ERC immediately. The 

district ERC will provide the information to OEM/OEO. The CDC assumes primary jurisdiction for 

foreign flag (non-U.S. registry) and U.S. flag vessels with international itineraries entering the U.S. 

and traveling in U.S. waters. See IOM 3.2.4.3.

8.2.2.3 - Outbreaks Involving Interstate Conveyances

Reports of illness attributed to travel on an interstate conveyance (plane, bus, train, or vessel) are a 

shared responsibility of FDA, CDC, USDA, EPA, and potentially others. When a report of illness is 

received, notify the district ERC in your division/district. The ERC will contact the CORE Signals Team 

at CORESignalsTeam@fda.hhs.gov. Please include the CFSAN Office of Food Safety Interstate Travel 

on any email correspondence (Joseph.morin@fda.hhs.gov ). In addition, you are encouraged to 

share the report with state and local public health officials. The following activities are to be 

coordinated with local/state public health officials: Interviews with the ill passenger(s), family 

members (well and ill), caregivers, and/or health professional (as appropriate) should be sufficiently 

probative to hypothesize if the food, water, or an environmental transmission is related to the 

illness. Transmission of illnesses, particularly viral diseases, by ill employees and contaminated 

environmental surfaces can result in illness carryover between successive trips and should be 

considered. Factors such as symptoms, time of onset of symptoms, food history for the 72 hours 

prior to onset of the first symptom, any clinical laboratory results, and other potential exposures 

should be documented. The carrier should also be contacted to determine if other reports of illness 

have been received (passengers and employees). Obtain any illness logs from the carrier. The 
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information developed should be evaluated to determine if further follow-up is necessary. On those 

carriers where a reservation system is used, obtain the names and phone numbers of passengers, 

and a passenger manifest, if available. If a reservation system is used, then a passenger manifest 

should also be available. A manifest will provide passenger seating, which will help identify 

additional cases based on proximity or in the event of an etiological agent like Norovirus, the 

passengers who occupy the seat on the next flight could also be at risk of infection. It may be 

necessary for the state/local health authorities, CDC or FDA to contact other passengers to 

determine if they became ill.

If additional cases are uncovered during these contacts, immediately notify the appropriate ERC in 

your division who will then contact the CORE Signals Team at CORESignalsTeam@fda.hhs.gov and 

the state and local public health authorities in all of the affected states. FDA will work cooperatively 

with these authorities and request their assistance in conducting an epidemiological investigation 

and collecting patient specimens. Note: If at any time the local/state public health officials are 

unable to assist with an investigation, have the district ERC notify CORE Signals Team at 

CORESignalsTeam@fda.hhs.gov who will contact the CDC and request assistance with the 

epidemiological investigation.

8.2.2.4 - Outbreak Management

CORE coordinates FDA’s efforts to prevent, detect, investigate, respond to, evaluate and apply 

lessons learned from foodborne outbreaks and public health incidents. Along with ORA, CFSAN

subject matter experts (SME), and others in FDA, CORE manages the strategy and implementation of 

outbreak response activities and evaluates environmental, epidemiologic, and laboratory data to 

inform assignments and direction of outbreak investigations related to foods, cosmetics, and dietary 

supplements. ORA’s primary role in the outbreak investigation is to perform activities related to 

tracing food from source to destination; food and environmental sample collection and analysis; and 

facility investigations.

If you become aware of a foodborne outbreak, contact the appropriate district ERC immediately 

who will then contact the CORE Signals Team at CORESignalsTeam@fda.hhs.gov. 

8.2.2.5 - Conducting Foodborne Illness Follow-up 

A priority for all foodborne illness investigations is to establish the basis for implementing control 

measures to stop transmission and prevent additional illnesses.

CDC is the federal agency with primary responsibility for investigating large, multi-state foodborne 

illness outbreaks. FDA plays a role in outbreak response generally by collecting samples, obtaining 

traceback information, and conducting food establishment inspections. CDC guidance for 

investigating foodborne illness is available at Investigating Outbreaks

(https://www.cdc.gov/foodsafety/outbreaks/investigating-outbreaks/index.html). SLTT generally 

conducts small, local foodborne illness outbreaks using generally the same process. In FDA, CORE 

guides investigations into the cause of foodborne illness outbreaks after notification from CDC that 

an outbreak is ongoing. 
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A resource for conducting epidemiological investigations is the Council to Improve Foodborne 

Outbreak Response (CIPHOR). Its website (https://cifor.us/) has many resources available to aid 

during an epidemiological investigation.

If you receive a report of a foodborne illness or an outbreak provide details to your district ERC and 

determine the extent of investigation you need to conduct. If you are required to respond to a 

foodborne illness outbreak use the following as guidance.

8.2.2.5.1 - Preparation

Divisions should maintain enough supplies of equipment used for sampling during a foodborne 

illness investigation. Assure all sterile supplies are within expiry. It is important that swabbing 

materials be monitored and utilized in a first in, first out manner to prevent the expiry of 

supplies. 

8.2.2.5.2 - Interviews

Reports of foodborne illness can come from many sources, such as:

• Laboratories

• Hospital-based laboratories

• Clinical laboratories

• National or regional commercial referral laboratories

• Local or state health department laboratories

• CDC laboratories

• Health care institutions

• Hospitals (e.g., hospitalized patients reported by infection control practitioners)

• Emergency departments

• Long-term–care facilities or nursing homes

• Physicians

• Schools and childcare centers

• Food establishments (e.g., restaurants) 

• State health departments 

Regardless of the source of the report, the diagnosis must be verified by a thorough case history 

and, if possible, by examination of appropriate food samples and clinical specimens. 

8.2.2.5.2.1 - Conducting Interviews

Normally, conducting foodborne illness interviews is not a role CSOs will perform since food 

history/symptoms are typically gathered by CDC and/or SLTT partners. Follow the guidelines 

upon contacting the affected person in the General Interview section (Section 8.1.6.1) of 

this chapter and the following:

• Identify yourself and explain the purpose of the visit or call.

• Ensure confidentiality.

• Conduct interviews in a private location.

• Be non-judgmental.

• Show empathy and attempt to build rapport with the interviewee.
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• Exhibit genuine concern for persons affected and be sincere and respectful 

when requesting personal and confidential information.

• Set your level of communication based on the person being interviewed.

• Be tactful. People are sometimes sensitive to questions about age, gender, 

special dietary habits, ethnic group, excreta disposal, and housing conditions. 

Phrase questions thoughtfully.

• While keeping the interview as conversational and as natural as possible, 

communicate a sense of urgency and emphasize the positive contribution 

already made by the interviewee toward the control and prevention of 

foodborne illness.

• Use open-ended questions. 

• Phrase your questions so the interviewee(s) will describe their illness and the 

foods and events which they feel are associated.

• Accurately record what interviewees say.

• Gently redirect, as needed.

• Probe if answers are vague, particularly about time of symptom onset. 

• Asking references may help their memory, for example, “What did you do prior 

to eating lunch?”

• Work with epidemiology staff to provide language interpretation, if needed.

• Thank interviewee at closing and explain how the information will be used.

8.2.2.5.2.2 - Information to Gather

Targeted, effective and pertinent information gathering is critical in a foodborne illness 

outbreak investigation. Per the CDC: Health officials use three types of data to generate 

hypotheses about the likely source of an outbreak: epidemiologic, traceback, and food and 

environmental testing. Investigators begin by trying to pinpoint how the pathogen spread. 

They review details such as:

• The specific pathogen causing illness

• Where sick people live

• How old they are, their sex, and race/ethnicity

• Did they have contact with a sick person

When a contaminated food is suspected, investigators must consider many different foods 

that may be causing the illness. Interviews help to establish a list of foods people ate before 

getting sick and collect information on other exposures such as restaurants where the ill 

person ate and stores where they bought food. This list is used to help investigators 

determine what food or ingredients the sick individuals may have in common. 

Consult with management, ERCs, CFSAN, SMEs, state liaisons, state partners, FDA, CORE, 

and others involved in the outbreak, as necessary, to determine what information is needed 

from the interviewee(s). Interview topics can include:

• Interviewee information

• Clinical information

• A standard list of food items
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• Each meal a person ate before becoming ill and all meals and snacks eaten 

seventy-two hours before onset of illness. The food, even the meal, which 

precipitated the illness, might not be obvious and the type of illness will 

sometimes provide clues:

− If the first and predominant symptoms are nausea and vomiting, 

concentrate questions on foods eaten recently.

− If the first and predominant symptoms are diarrhea and abdominal 

cramps, foods eaten six to twenty hours before onset of illness are

suspect.

− If diarrhea, chills and fever predominate, foods eaten twelve to 

seventy-two hours before onset of illness are suspect.

− More unusual illnesses often present different clinical patterns. For 

instance, some illnesses such as Typhoid Fever and Hepatitis A, have 

incubation periods greater than 72 hours.

• Food allergies, special diets, vitamins, and supplements

• Sources of food at home/outside of the home

• Animal contact and pets

• Specific food categories

• Food shopping habits

• Travel

• Restaurant dining

• Attendance at events where food was served

Although some may not have been ill, use this detailed interview approach with each 

individual identified in the initial complaint or alert, until there is sufficient information to 

determine the scope and source of the foodborne illness outbreak.

8.2.2.5.3 - Medical Records

Physicians' and hospitals' records can be useful in verifying reported signs, symptoms and other 

clinical data and can sometimes rule out the possibility of foodborne illness. See General Section 

on Medical Records (Section 8.1.6.2).

8.2.2.5.4 - Sampling Procedures

CAUTION: Never taste any of the food products. Handle all samples with caution to 

prevent accidental exposure to and/or ingestion of even minute amounts of the 

contaminated or suspect product.

8.2.2.5.4.1 - Sample Collection

During investigations of foodborne illnesses, cooperate with other public health officials in 

collecting samples of items that may be associated with the outbreak.

Use interview information and a menu or data from an attack-rate table to determine which 

of the foods from the implicated meal are most suspect and collect samples of the suspect 

foods. Check storage areas for items that may have been overlooked. Check garbage for 

discarded foods or containers. Suspect foods often are discarded by an operator if he thinks 

someone may have become ill as a result of eating in his establishment. Because one of the 

primary tasks of the investigator is to prevent further illness, take appropriate action to 
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prevent distribution or serving of any suspect food. If no foods remain from the suspect 

meal or lot, try to collect samples of items prepared in a similar manner, but subsequently 

to the suspect lot. Collect ingredients or raw items used in the suspect food. Determine 

supplier, distribution, and code information on ingredients and packaged foods to aid any 

investigation of the same lot in distribution channels. 

Collect samples aseptically. If foods are to be examined for organophosphate pesticides or 

heavy metals, do not use plastic containers. Use glass jars with foil-lined lids because 

substances from the plastic can leach into the food and interfere with analysis.

The following are examples of articles normally collected:

• Remaining portions of all suspect foods.

• Parent stocks of suspect foods.

• Insecticides, rodenticides, or other poisons which may be involved.

• Suspect food containers such as cans, bottles, etc.

• Utensils or materials used in the preparation and storage of the suspect food.

• Table scrapings and food residues from equipment such as slicing machines, 

cutting boards, etc.

NOTE: Clinical specimens such as vomitus, stools, swabs of nasal and throat passages, or 

open sores or lesions of food workers are collected by local, state, or CDC health officials or 

private physicians. Do not collect these samples.

8.2.2.5.4.2 - Sample Size

In general, follow the IOM SAMPLE SCHEDULE in Charts 1, 2, and 3 (IOM, Chapter 4). Where 

only small amounts of items remain, such as partial meals/leftovers, empty containers with 

adhering particles, etc., collect all or as much as possible by scraping from utensils, 

equipment, or containers. It may also be necessary to collect the empty containers. 

8.2.2.5.4.3 - Sample Handling

Record the temperature of the room, refrigerator, or warmer in which the food was stored, 

and the temperature of the food that remains after a sample is collected.

Inform the laboratory of the type and number of samples. Discuss methods to preserve and 

transport samples, time of arrival, and the person who will receive the shipment.

Follow guidance in Chapter 4 for collecting, handling, and shipping samples. See IOM 

4.7.5.6.

If the suspect food is a commercial product, examine the original package or container for 

coding information to identify the place and time of processing. Your division may notify all

agencies responsible for regulating the products alleged or suspected to have caused the 

illness. Collect additional packages bearing the same code number for analyses for 

microorganisms, toxins, seam defects, vacuum, leaks, or other conditions. Be as specific as 

possible in requesting the type of analysis.
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8.2.2.5.5 - Establishment Investigation

After a foodborne illness outbreak is reported and an investigation is initiated, the initial impact 

of the incident can create confusion at the facility and could result in conflicting information if 

too many entities become involved.

The responsibility for investigating foodborne illness outbreaks rests on a core team of people 

who each contribute different knowledge and skills. For FDA-initiated investigations/inspections, 

one FDA investigator should be designated as the inspection team leader. The team leader will 

set and enforce priorities, coordinate all activities associated with the investigation, serve as the 

point of contact about the investigation, communicate with other organizations involved in the 

investigation and communicate the recommended course of action determined by team to ORA

management. A supervisor and/or ERC should be the coordinator for overall division activities 

and the division contact for headquarters personnel. All communications from FDA field or other 

offices to the firm's management should be channeled through the supervisor/ERC. The lead 

investigator should be responsible for all phases of the physical inspection of the facilities and 

briefing the supervisor about team progress. See IOM 5.1.2.5.2.

Upon arrival at the establishment where the suspect food was processed or prepared, identify 

yourself to the person in charge and state the purpose of your visit. Emphasize the purpose of 

the investigation is to determine what contributed to the outbreak, so preventive measures can

be taken. Attempt to create a spirit of cooperation. Consider the position, feelings, and concerns 

of the manager and facility staff; defensive reactions are common.

Many factors could have contributed to contamination before foods came under the control of 

the manager. Assure the manager that these possibilities will be investigated. Inform the 

manager of the activities proposed and benefits gained for educating their workers. 

When investigating the root cause of the contamination obtain the following documents: 

inspection reports (state and/or federal), detailed epidemiological data and traceback 

investigation reports to try to pinpoint locations of interest, environmental monitoring records, 

verification records of the identity, safety, strength, purity, efficacy, and accuracy of raw 

materials and packing materials used, and any analysis of resource availability, (e.g., 

documenting sufficient manpower and prescribed raw materials, packaging materials utilized, 

substitutions made, etc.), and historical data on weather events, e.g., flooding, for foods 

produced in the open outdoor environment. 

Perform the following activities: 

1). conduct personnel interviews to determine their qualifications, knowledge, experience, and 

training; 

2). review related logbooks, records, processes, laboratory data; 

3). document observations made with photos and videos whenever possible; 

4). visit the facilities or farms, where causes of the event occurred (where possible). 
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5) Describe the processes, equipment and facilities. 

6) Evaluate the following: the suitability of equipment, facilities, and utility systems; the 

calibration and preventative maintenance of the equipment and instruments used; the 

adequacy and the implementation of the relevant standard operating procedures (SOP) utilized 

by the food business operator; and the Good Manufacturing Practices (GMPs), preventive 

controls and food safety standards, as applicable, utilized in the area where the product 

concerned was produced, processed, packed and/or held. 

Include all relevant information in the investigation memo or EIR as appropriate.

Review of distribution records and examination of warehouse stock are two important aspects 

of a foodborne illness follow-up inspection. Field examination should include an inventory by 

code of all stock on hand. When conducting field examinations, follow instructions in IOM 

Sample Schedule Chart 2 (IOM, Chapter 4).

8.2.2.5.5.1- Food Handlers Interviews

If a food is already suspect, interview separately all persons who were directly involved in 

processing, preparing, or storing of the food and others who could have observed 

preparation and storage. Ask questions in a sequence that discloses the flow of food from 

the time it was received until it was served or distributed. Especially inquire about foods 

that were prepared several hours or days before being served with the suspect meal and 

about foods that have specific temperature requirements. Ask similar questions, suitably 

modified, of the managers or workers who were involved in producing, transporting, 

processing, preparing, or storing food at other levels of the food chain, as well as individuals 

who prepared the food at home.

Food workers who fear criticism or punitive action because of their possible role in the 

outbreak do not always accurately describe the food handling as it actually happened. Their 

descriptions should be plausible, account for possible sources of contamination, and 

indicate possibilities of survival and potential for growth of pathogens. If the description 

does not contain all the information desired, rephrase the questions and continue the 

inquiry. Seek confirmation of one person's story by talking to others who have knowledge of 

the food operation, or by watching the food preparation or processing practices. Be alert for 

inconsistencies among the accounts, as told by different individuals.

8.2.2.5.6 - Possible Contamination Source

It is important to understand the pathogen and the factors that contribute to the contamination 

that resulted in the foodborne illness. Some pathogens, such as Norovirus, are associated with 

human fecal contamination, while other pathogens, may be more commonly associated with a 

particular food source (e.g., raw meat and E. coli O157:H7). 

CDC has identified the most common causes of foodborne illness:

• Food from unsafe source.
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• Poor personal hygiene.

• Improper food holding temperatures.

• Improper cooking temperatures

• Contaminated equipment of cross-contamination of raw with ready-to-eat foods

You may want to familiarize yourself with Factors that Contribute to Outbreaks of Foodborne 

Illness (https://www.cdc.gov/nceh/ehs/nears/factors-contribute-to-outbreaks.htm ) before 

beginning a foodborne illness investigation. 

Exhibit 8-5 (https://cifor.us/uploads/resources/CIFOR-OUE-Agent-List_FINAL.pdf) provides 

details about possible food associations with different illness symptoms, latency and factors that 

contribute to outbreaks. Although the table lists possible clinical specimens to collect, you 

should not collect clinical samples. A SLTT health department may be able to assist and collect 

those samples for analysis at a state laboratory. 

8.2.2.5.7 – Conducting Traceback Investigations

Traceback investigations are important epidemiological tools that are used to determine the 

source of food implicated in foodborne outbreaks. Traceback investigations may prevent further 

sale and distribution of contaminated food. Commonly, SLTT agencies conduct the initial 

epidemiological investigation of foodborne outbreaks and identify suspect product(s) requiring 

tracebacks. 

CORE issues traceback assignments to the appropriate division(s) and coordinate inter-division 

assignments for traceback investigations. The assignment will generally provide all the guidance 

needed to conduct the traceback investigation. 

Other resources available include:

• the FDA Guide to Traceback of Fresh Fruits and Vegetables Implicated in Foodborne 

Outbreaks, dated April, 2001 

• the Office of Training Education and Development (OTED) training: ER220: Traceback 

Investigations. 

8.2.2.6 - Reporting

8.2.2.6.1 - Reporting Epidemiological Investigations 

Follow the reporting guidance in this chapter to report epidemiological investigations. Promptly 

submit a complete narrative of the investigation, including references to exhibits, samples, 

medical records, and laboratory reports. There is no prescribed reporting format, but it should 

be in a logical order. With the inclusion of investigative memos in eNSpect EIR, eNSpect can be 

utilized to prepare these memos. See the eNSpect EIR Quick Reference Guide for detailed 

information. See also IOM 8.10.

Submit copies of any written reports and documents for all injury or illness complaints involving 

all CFSAN products (see section 8.2 and 8.4.5) using encrypted email, secure fax transmission, or 

mailing. 
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If using mail, use this address:

Food and Drug Administration

CFSAN/OSAS

CAERS Staff (HFS-700)

5001 Campus Drive

College Park, MD 20740

Attn: CAERS Monitor

Illness/injury complaints involving special nutritional products (refer to IOM 8.2.3.2) must be 

accompanied by a completed FACTS Adverse Event Questionnaire when forwarded to CFSAN. 

If additional follow-up on any complaint involving a CFSAN product is necessary, the Division of 

Field Program Planning and Evaluation (HFS-635) will issue an assignment.

8.2.2.6.2 - Reporting Food Adverse Events 

Prompt reporting is essential. You may save the lives of others with prompt reporting. If 

consumers contact you to report adverse events including injury, illness, or death related to a 

human or animal food, dietary supplement, or cosmetic, they should be directed to report 

through the following online reporting systems. If they do not want to report through those 

systems, you may report for them. 

8.2.2.6.2.1 - Food and Cosmetics

Details on reporting adverse events related to human food can be found at the CFSAN

Adverse Event Reporting System (CAERS) website 

(https://www.fda.gov/food/compliance-enforcement-food/cfsan-adverse-eventreporting-system-caers).

8.2.2.6.2.2 - Dietary Supplements

Details on reporting adverse events related to dietary supplements can be found at the 

How to Report a Problem with Dietary Supplements website 

(https://www.fda.gov/food/dietary-supplements/how-report-problem-dietarysupplements).

8.2.2.6.2.3 - Cosmetics

Details on reporting adverse events can be found at the How to Report a Cosmetic 

Related Complaint website (https://www.fda.gov/cosmetics/cosmetics-complianceenforcement/how-report-cosmetic-related-complaint).

8.2.2.6.2.4 - Veterinary Products

Details on reporting adverse events and complaints for animal food and animal medical 

products can be found at the CVM Report a Problem website 

(https://www.fda.gov/animal-veterinary/safety-health/report-problem).
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8.2.2.6.2.5 - Reports of Criminal Activity

If a consumer calls to report criminal activity, they should be directed to the Report 

Suspected Criminal Activity website 

(https://www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm).

8.2.3 - Injury, Illness, Death 

Injury and adverse reaction complaints should receive a prompt, courteous response, and assurance 

their complaints will receive appropriate consideration. An immediate follow-up should be made when 

there is an indication of a serious injury or adverse reaction.

When you are investigating injuries or adverse reactions, do not make comments or enter discussions 

with firms as to the involvement of particular products, unless specifically instructed to do so. Many 

adverse reactions come to FDA from consumers or health care professionals through the voluntary 

reporting branch of the MedWatch system. These reports are to be held confidential. 

Whenever the press has been informed about a complaint, follow instructions found in Section 1.6.1. 

When the responsible firm invites the news media to observe the inspectional process, follow 

instructions found in Section 5.1.4.3.

NOTE: CFSAN Adverse Events Reporting System (CAERS) Staff, HFS-845, 240-402-2405, Fax: 301-436-

2452, or email CAERS@fda.hhs.gov, can assist with questions pertaining to field follow-up related to 

foods, seafood, food additives, dietary supplements, infant formulas, and medical foods. CAERS 

personnel can assist in obtaining guidance from CFSAN's experts.

8.2.3.1 - Procedures 

When investigating all injuries and adverse reactions the consumer complaint coordinator will 

follow SOP-00045 Consumer Complaint Procedure. 

Once it is determined by program management that follow-up is deemed necessary, an assignment 

will be created and assigned to a CSO, who will then fill out the Follow-up Consumer Compliant 

Report in FACTS. 

The following should be addressed and confirmed during a follow up investigation with the 

complainant. 

• Details on the product involved, including brand name, product labeling, and any codes 

including lot, expiry, and/or use by codes.

• The source of the product. Where did the consumer obtain it? 

• Details of how the product was used, including frequency, in what amounts, any known 

previous adverse reactions or pre-existing allergies and whether anyone else used the 

product in the household. 

• If appropriate, determine if label directions were followed. 

• Copies of all labeling/inserts. 
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• Any research the complainant may have conducted or relied upon and collect copies or 

internet web addresses. 

• Complete description of the incident (sequence of events) and the nature of the injury

or adverse reaction, including date, time, location, and symptoms or description of 

injury.

o Any hospital or physician's records available and identify pre-existing conditions 

which may have a bearing on the injury or adverse reaction.

o Photographs of the victim's injuries, if significant. See Section on Medical Records.

• List names of other persons involved, such as beauty salon operators, medical 

personnel, lawyers, insurance agents. Obtain their views on the injury or adverse

reaction. The views of an attending physician are important because they may vary 

markedly from those of the patient.

• Determine if the consumer reported the adverse reaction to the manufacturer and the 

manufacturer's response.

• Any other consumer complaints, injuries or alleged adverse reactions reported to the 

manufacturer concerning the product.

• If necessary, obtain distribution information of the implicated lot(s) from the 

manufacturer.

8.2.3.2 - Specific Product Reporting (Food, Dietary Supplement, and Cosmetic 

– Injury or Reaction)

8.2.3.2.1 - Dietary Supplements 

It is extremely important that FDA conducts appropriate investigations and follow-up on adverse 

events attributed to dietary supplement products. DSHEA removed dietary supplement and 

ingredients from food additive regulations and therefore it is the agency’s burden to prove them 

unsafe. An important source of information concerning potentially unsafe dietary supplements 

and ingredients is consumer complaints. 

Injuries or other adverse reactions may be associated with the use of products which:

• Vary from the declared potency or concentration.

• Contain deleterious substances accidentally included in manufacturing.

• Have changed composition or become contaminated after shipment.

• Are mislabeled as to identity warnings or instructions for use.

• Have not been used according to label instructions or the directions of the manufacturer 

or prescriber.

• Are dangerous when used according to directions.

When investigating adverse events attributed to dietary supplements, direct attention to, and 

document:

• Details on the product involved, including lot codes and expiration dates.

• Source of the supplement. Where did the consumer obtain it?

• Details on the consumer’s use of the product including frequency, dose used, 

concomitant treatments, and whether administered by the user or someone else. 
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• Details on the directions of use provided with the product or otherwise (on the web or 

from a practitioner). Obtain copies of labeling and any additional information 

concerning use of the product by the consumer.

• Nature of the injury. Include any hospital or physician's records available and identify 

pre-existing conditions which may have a bearing on the injury. Obtain photographs of 

the victim's injuries, if significant. See IOM 8.1.6.2 for the procedures used to obtain 

medical records. 

• Names of other persons involved, such as medical personnel, lawyers, insurance agents, 

etc. Obtain their views on the injury. The views of the attending physician are important 

because they may vary markedly from those of the patient.

• Complete description of the incident (sequence of events) and the nature of the injury

or adverse reaction, including date, time, location and symptoms or description of 

injury.

• Any hospital or physician's records available and identify pre-existing conditions which 

may have a bearing on the injury or adverse reaction. 

Photographs of the victim's injuries, if significant. See Section on Medical Records

8.2.3.2.2 - Cosmetics 

For clarification of the distinction between cosmetics and drugs, refer to the document, “Is it a 

cosmetic, a drug or both? (or is it soap?)” located at https://www.fda.gov/cosmetics/cosmeticslaws-regulations/it-cosmetic-drug-or-both-or-it-soap

If you are unsure about a products status you may contact the Office of Cosmetics and Colors at 

(240) 402-1130.

8.2.3.2.2.1 - Causes 

Injuries or adverse reactions may arise from cosmetics which:

• Are inherently dangerous or which may prove harmful or injurious to a consumer. 

• Cause primary irritation of skin, eye, or mucous membranes (including the lungs 

and urinary tract) or which may be due to an individual sensitization reaction or 

allergic response, or due to ingestion. 

• Have undergone formulation changes or been chemically or microbiologically 

contaminated while in the possession of the manufacturer, dealer, distributor, or 

end user. 

• Are misbranded because they contain unlisted ingredients, lack instructions for 

safe use for certain high-risk products (e.g., depilatories, hair dyes), or lack any 

required warning statements. 

• Have been misused.

8.2.3.2.3 - Investigation Requirements for Serious Adverse Events of CFSAN Regulated 

Products 

If the suspect product is a cosmetic, interview the injured person and/or the reporter of the 

event and complete the FACTS Consumer Complaint Cosmetic Report. If the suspect product is 
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not a cosmetic, interview the injured person and/or the reporter of the event and complete the 

FACTS Adverse Event Questionnaire. 

If the suspect product is an infant formula or baby food, immediately inform OEM/OEO at 866-

300-4374 or Emergency.Operations@fda.hhs.gov and investigate on a high-priority basis due to 

the continued sensitivity to these incidents. This will include follow-up with the doctor or 

hospital, sample collection, and analysis of appropriate product. Refer complaints involving baby 

food regulated by USDA for appropriate follow-up. See IOM 8.1.8.1 and 3.2.1.2.

Obtain Medical Records as described in Section 8.1.6.2.

If the adverse event is a death, the following medical records should be considered for 

collection:

• Admission history and physical or emergency room/clinic record of the event if the 

patient was not admitted

• Discharge Summary

• Autopsy Report

• Death Certificate

If you believe a suspect product should be sampled, discuss with your supervisor.

For all events, a memo of investigation will be completed. Send a complete copy, including 

copies of all labels and labeling, Medical Records Letter [IOM Exhibit 8-4] and medical records 

collected to the CAERS Staff.

8.2.3.2.4- Undeclared Allergen/Allergic Reactions 

Suspected undeclared allergen complaints should receive high priority. Undeclared allergens in 

food products often result in recalls.

The following should be addressed and confirmed during a follow-up investigation with the 

complainant: 

• List all the complainant’s food allergies.

• List all foods consumed within approximately an hour prior to reaction.

• Amount of suspect food consumed.

• Time of on-set.

• Specific symptoms experienced and the order they occurred.

• Medical or other treatment received.

• The ingredient statement from product packaging.

• Any label statement related to a “may contain” statement and record the statement.

Inspectional follow up at the manufacturing plant may be warranted to determine if suspect 

allergen is added to the product; or if the possibility of cross-contact exists.
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8.2.3.3 - Veterinary Products-Complaints/Adverse Reactions 

If you become aware of human illnesses associated with CVM-regulated products, contact the 

appropriate ERC in your division and/or regional office immediately who will then contact the CORE 

Signals Team at CORESignalsTeam@fda.hhs.gov. 

Investigations of complaints of animal food, both medicated and non-medicated, should be 

investigated like other complaints. Discuss any investigation with your supervisor. The CVM Office of 

Compliance can be consulted concerning appropriate follow-up and sample collection related to 

complaints. 

8.2.3.4 - Sample Collection

When directed to collect a sample, collect the product which appears to have caused the injury and 

an official sample from both the same and other lot codes, if available. Check with your supervisor if 

you have any doubt as to the appropriateness of collecting a sample related to an investigation.

See IOM 4.7.5.4.1 for routing of injury and complaint samples to the laboratory.

8.2.3.4.1 - Cosmetic Samples

Many cosmetic products such as permanent hair dyes, home permanents, deodorants, hair 

straighteners, etc. are known to cause adverse reactions. Samples of these products should not 

be collected except in cases of alleged severe or unusual injury (e.g., multiple complaints). In 

cases of obvious allergic type reactions, samples should not be collected. For example, most 

cosmetic products which get into the eye will cause temporary eye irritation and, in such cases, 

a sample generally should not be collected.

8.2.3.4.2 - Microbiological Contamination

Collect samples associated with consumer complaints in which microbiological contamination is 

suspected.

8.2.3.4.3 - Allergen Samples

Collect a sample if the allergen is visible (i.e., nuts,) is not declared on the label, and if deemed 

necessary by division management. In all other cases, collect a sample only after consultation 

with OEM/OEO (e.g., national consumer complaint coordinator) and CFSAN. See IOM Sample 

Schedule Chart 13 for guidance on sample size. Note: the sample size may be modified 

depending on product availability.

8.2.4 - Special Events

Special Events (SEs) are organized, pre-planned mass gatherings of national or international importance 

that usually garner significant media coverage and are typically attended by dignitaries or public 

personalities. The venues for these events are frequently stadiums, arenas, convention centers, and 

hotels which contain retail food establishments that are under the jurisdiction of state and local 

agencies. SLTTs, United States Secret Service (USSS), or the event organizer may request FDA assistance. 

You may be requested to investigate food suppliers to the SE to verify compliance with regulations. This 

investigation, referred to as a Supply Chain Integrity Check (SCIC), may be performed onsite or through 
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an online record review. The SCIC entails a review of a firm’s inspectional and compliance history, 

including recalls, Reportable Food Registry (RFR) and whether the firm has been involved in a CORE 

investigation. (See IOM Chapter 3.2.5.2.9 for full details on SEs)

8.2.5 - Farm Investigations

A farm investigation of a raw agricultural commodity (RAC) may be conducted in response to traceback

information obtained during a foodborne illness outbreak investigation that implicates one or more 

farms, ranches, packing houses, or other such operations as being involved in handling the outbreak 

suspect RAC. Generally, CORE would request a domestic farm investigation through the district ERC for 

the responsible ORA Human and Animal Food (HAF) program division office. HAF program division 

offices may also initiate or be assigned by CFSAN or ORA/OHAFO to perform a farm investigation as 

needed to protect public health. The goals of a farm investigation are to gather information, to identify 

potential environmental sources of the outbreak agent, to identify routes of contamination from 

potential outbreak agent sources to the implicated RAC, to observe and document potential 

contributing factors to the outbreak such as practices, procedures, or conditions that may facilitate 

proliferation, spread, growth, survival, or contamination by the outbreak agent, and to support 

regulatory action, if appropriate.

8.2.5.1 - Approach

A team approach is utilized for a farm investigation (see IOM 5.1.2.5 Team Investigations). A lead 

CSO should be identified from the Produce Safety Network (PSN) or the responsible HAF division 

office that has attended both the FD226 Produce Inspections for Regulators Course, and the FD326 

Produce and Sprout Investigations for Regulators Course. A minimum of three team members 

should participate and ideally all members should have produce farm training and/or produce farm 

inspection experience. The appropriate state regulatory agency having jurisdiction over produce 

farms should be notified and invited to participate. Additional SMEs may be added to provide 

needed expertise such as wildlife, soils, agricultural water, or epidemiology. CORE, CFSAN Produce 

Safety Staff, and/or ORA HQ may assist with identifying appropriate SMEs and providing technical 

guidance during the investigation.

The implicated grower should be notified in advance of the investigation as he/she or a 

representative of the grower will need to be present to provide information to assist the 

investigation. Generally, an FDA 482 will be issued to the grower or packing house, if different. If the 

investigation expands to fields not owned by the grower, a new 482 must be issued to those 

growers. Please see IOM 5.1.3.5 Team Investigations for additional information.

CORE has implemented formalized outbreak incident operation processes. The CORE operation 

guides are available through the inside.FDA.gov website. 

 

8.2.5.2 - Sampling

A variety of environmental samples may be collected during a farm investigation, including 

environmental swabs and water from both the field and the packing house, and soil and wildlife scat 

samples from the growing environment. Do not collect human fecal matter unless specifically 

assigned or pre-approved to do so. In general, FDA laboratories are not prepared to receive human 

feces. 
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Instructions for collecting soil and water samples on farm investigations are found in IOM Ch. 4, in 

the Salmonella Sample Schedule Chart 1, and are also covered in FD326 (Produce and Sprout 

Investigations for Regulators Training Course). Additional sampling guidance can be found in SOP001052 (ORA Field Bulletin #30 – Food Program Area – Instructions for Environmental Sampling), 

and ORA Outbreak Response Field Guide #1 covering E. coli, Listeria, and Salmonella inspections and 

investigations at sprout operations. Specific sample collection instructions or methods may also be 

included in the CORE farm investigation assignment.

All environmental samples are investigational. Use the product code builder to identify the proper 

code for the type of environmental sample collected, including swabs, soil, water, and animal scat. 

Do not use the product code of the implicated produce for environmental samples. Produce samples 

collected from the field or prior to packing (i.e., not finished product) are labeled as investigational. 

Product that has completed processing on the packing line are labeled official product samples.

8.2.5.3 - Form 3623 Farm Investigation Questionnaire

FDA Form 3623, the Farm Investigation Questionnaire (FIQ), must be completed for all farm 

investigations, as covered in FD3263. Some portions may not be applicable, such as the use of 

biosolids. These questions may be marked as N/A. However, questions for practices that may be 

used but are not currently in use should be completed by use of interview techniques with the 

grower to the extent possible. The FIQ should be completed on-site to ensure all information is 

collected and submitted to CORE and/or the CFSAN Produce Safety Staff if requested and included in 

the Investigation Memo or EIR as an attachment. To avoid duplication, the FIQ may be used to 

provide information under the “Manufacturing Processes” section by either reference or cutting and 

pasting into that section. A short summary and flow diagram(s) describing the steps from planting 

through harvesting and/or packing should be included along with this.

8.2.5.4 - Reporting

Domestic outbreak work assignments will be designated in FACTS as either an operation 12 

inspection (OP12) or an operation 13 investigation (OP13). Foreign outbreak work assignments will 

be designated in FACTS as either an operation 11 inspection an operation 15 investigation. 

For FACTS operation 11 or 12 farm inspections see Chapter 5 for reporting; however, if an outbreak

is ongoing and the information is needed immediately, it may be necessary to prepare a separate 

memo to submit to CORE prior to completing the EIR. 

For FACTS operation 13 or 15 investigations, follow reporting guidance in this chapter. 

8.2.6 - Infant Formula and Baby Food

There is a continued sensitivity to all reported incidents involving infant formula and baby food. All 

complaints involving either infant formula or baby food are to be thoroughly investigated on a highpriority basis. This includes with the consumer, inspection of the manufacturer, and with the doctor or 

hospital if appropriate. Samples should be collected as part of the follow-up. Complaints involving baby 

food regulated by USDA should be referred to USDA for appropriate follow-up. See IOM 3.2.1.2. There 
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are two exceptions for collecting samples as part of the follow-up to infant formula/baby food 

complaints. Do not collect samples unless direct for: 

• Complaints involving outdated product in the marketplace with no associated injury or illness 

only require investigation to ensure all outdated product has been removed from the identified 

retail and/or wholesale source.

• Complaints involving an illness associated with normal appearing product when the follow-up 

investigation discloses that the event does not appear to be product related or was an allergic 

response to a properly labeled product per a physician's diagnosis.

8.2.7 - Tampering Involving Alcoholic Beverages

All tampering complaints involving alcoholic beverages should be entered as a consumer complaint in 

FACTS. OEM/OEO and OCI should be notified immediately. OEM/OEO can be notified by e-mail at 

emergency.operations@fda.hhs.gov and by phone 24 hours a day at 1 (866) 300-4374. 

For all other complaints involving alcoholic beverages, please see IOM 3.2.8.1 for guidance.
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8.3- Drug Investigations 

8.3.1 - Investigations Coordination

The following procedures should be followed for investigating suspected adverse drug reactions, 

including drug-induced birth defects:

• If you are interviewing the consumer, conduct the normal complaint investigation and 

gather all pertinent information regarding the product, patient, adverse event, etc. If the 

consumer received medical treatment, obtain a medical records release (Exhibit 8-2). 

Reporting of drug adverse experiences is voluntary and you should encourage and assist 

complainants and health care providers to complete the MedWatch form (FDA 3500) (see 

Exhibit 8-10) and submit to MedWatch. Report your findings in the FACTS Consumer 

Complaint follow-up screens and in a memo of investigation.

• If you are investigating an adverse reaction at the manufacturer, conduct your investigation 

to determine whether the adverse event was caused by a drug quality defect. Determine if 

the manufacturer was aware of the complaint, has investigated, and per IOM 5.5.7 Adverse 

Event Reporting has submitted the reportable event to FDA. For additional information 

regarding DQRS (MedWatch Reports) and NDA FARS (New Drug Application Field Alert 

Report) see the applicable compliance program in the Compliance Program Guidance 

Manual (CPGM). Determine if the manufacturer is aware of any similar reported events. 

Collect current labeling of the product to determine whether this was an expected or 

unexpected adverse event. Your findings will be reported through the FACTS Consumer 

Complaint follow-up screens and a memo of investigation or EIR.

• You may also be directed to conduct investigations at other establishments, such as 

pharmacies, doctors’ offices, or distributors. Conduct your normal complaint investigation 

determining each party’s role and involvement. If individuals interviewed are not required 

to report adverse drug reactions, encourage and assist them to complete and submit the 

FDA 3500 form to MedWatch.

In all cases of suspect drug-induced adverse reactions, the center will review the information on the FDA 

3500 form and will issue assignments to the field if additional information is needed.

8.3.2 - Illness/Injury

Drug injuries or reactions, either human or veterinary, result from the use of products which may:

• Vary markedly from declared potency.

• Contain deleterious substances.

• Be mislabeled as to identity, warnings, or instructions.

• Have been mistaken for other drugs despite proper labeling.

• Have changed composition or become contaminated after shipment.

• Be dangerous when used according to directions.

• Have not been used in accordance with label directions or directions from the prescriber.

• Have been improperly administered or administered without the necessary precautions.

• Have been contaminated with objectionable microorganisms, soaps, or cleaning

solutions.

• Have been misidentified.

• Be labeled as sterile drugs but are found to be non-sterile.
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• Have adverse effects that were not identified prior to marketing.

8.3.2.1 - Reporting

8.3.2.1.1 - Reporting Forms – Drugs

Submit drug complaints and injuries to:

MedWatch

The FDA Medical Products Reporting Program (HFD-410)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857

Fax Number: 301-827-7241

8.3.2.1.2 - Reporting Forms – Veterinary Products

Submit veterinary injuries or adverse reaction reports to:

Food and Drug Administration

Center for Veterinary Medicine

Division of Surveillance (HFV-210) 

7500 Standish Place

Rockville, MD 20857

In addition, follow specific reporting instructions as indicated per an assignment

8.3.3 - Complaints

The FDA Office of Emergency Management/Office of Emergency Operations (OEM/OEO) HFA-615, 301-

796-8240 must be notified immediately of all significant injury, illness, and suspected tampering

complaints. This may be accomplished via the checkbox indicated in the FACTS Consumer Complaint. 

• Injury/illness complaints 

o Any illness/injury related to infants should be considered significant. These complaints

are to be thoroughly investigated on a high-priority basis.

• Complaints and adverse reactions associated with veterinary products including animal drugs, 

medicated feeds, and medical devices for animals are handled through the FDA CVM Division of 

Veterinary Product Safety (HFV - 240). Veterinarians, animal owners, and drug manufacturers 

may report problems to their local FDA district offices or directly to CVM. The division should 

advise the complainant to complete an FDA 1932a, "Veterinary Drug Adverse Experience, Lack 

of Effectiveness or Product Defect Report" for drug adverse events associated with unapproved 

animal and approved human drugs and veterinary devices. For approved animal drugs, the 

complainant should be instructed to call the manufacturer directly to report the event. Detailed 

instructions and options for different case scenarios are available at 

https://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/default.htm. 

For 3-day Field Alert Reports (FAR), drug sponsors now have the option to electronically submit 3-Day 

field alert reports (FARs) directly to CVM. CVM will receive the electronic 3-Day FAR from the sponsors 

and will automatically generate and email a .pdf of the FAR with associated attachments to the 

appropriate district office. Some sponsors may still send the 3-day FAR through the traditional route to 

the district office. The district office should email the form and any other attachments to CVM. The 
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drug manufacturer should notify and submit the FAR to their respective district office within three days. 

The district offices will ask for additional information if necessary and submit the 3-day FAR to the 

Division of Veterinary Product Safety.

Complaints and adverse reactions associated with animal feeds including pet food products are handled 

through the Division of Compliance (HFV-230) at CVM. Veterinarians, animal owners, and firms may 

report pet food problems to consumer complaint coordinators at their FDA district office or OEM/OEO; 

the district will complete a FACTS Consumer Complaint Report. Pet food reports may also be made 

directly to CVM using FDA’s Safety Reporting Portal. Instructions for stakeholders to report problems 

associated with pet food products are available at 

https://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/default.htm. If you become 

aware of human illnesses associated with CVM-regulated products, contact the appropriate ERC in your 

division and/or regional office immediately who will then contact the CORE Signals Team at 

CORESignalsTeam@fda.hhs.gov. 
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8.4 - Device Investigations 

8.4.1 - Injury/Illness

When investigating incidents implicating medical devices, you must first confirm whether the device was 

a contributing factor. An appropriate follow-up, such as an inspection at the manufacturer may be 

necessary. The cause of medical device injuries may originate with the manufacturer, operator, user, or 

from other factors including, but not limited to, the transportation or installation of the device. 

Additionally, an illness may occur as a result of device specifications not being met, such as a device 

labeled as sterile not meeting sterility requirements.

Obtain the following information for medical devices: 

1. A complete description of the incident (sequence of events) and the injury/illness, including:

a. Type, model, serial number and manufacturer of the device, and copies of any labeling 

for the specific device(s) involved including instructions for use or operations manual(s). 

b. Details of the alleged incident, including: number of people involved; symptoms, onset 

time, duration, and outcome; date and time of occurrence; reports of other 

investigating agencies and their conclusions, (e.g., fire marshal or OSHA reports); similar 

incidents which may have resulted in injury/illness; and all operational SOPs, written or 

unwritten. 

2. Copies of medical records and/or laboratory records. Use an FDA 461, Authorization for 

Medical Records Disclosure, IOM Exhibit 8-2, signed by the patient or other authorized 

person, when obtaining these records. 

3. Official cause of death, death certificate, and/or autopsy report, if indicated. 

4. Determine if the device malfunctioned, and the cause. 

5. The condition of the device at the time of use. Review its maintenance history, including 

responsibility for maintenance (past and present), special service calls, repairs, whether 

component warning or safety systems were functional, maintenance records, changes or 

corrections accomplished just prior to or immediately after the incident, and who 

performed the activity. An interview with biomedical engineering department personnel 

may be indicated.

6. Who has access to the device? Determine if individuals using the device are familiar with its 

operation.

7. The results of any examination or inspection of the device by the hospital or other party to 

determine the cause of the incident. 

8. Whether there are other devices of the same model number or lot number on the premises.

8.4.1.1 - Types of device injuries or illnesses include:

8.4.1.1.1 - Mechanical, Electrical, or Electromechanical Devices

Injuries caused by mechanical, electrical, or electromechanical devices may result from devices 

that:

• Do not conform to specifications due to mistreatment (e.g., damage in transit), or

failure to comply with good manufacturing practices.

• Malfunction due to incorrect installation.

• Have not been used in accordance with labeled instructions.
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• Have been used/installed with incompatible accessories or parts which are not 

compatible.

• Have been used under conditions which interfere with their ability to function (e.g., 

electromagnetic interference (EMI), fluid seepage into electrical circuits, etc.).

• Have been damaged during use, or random failures.

• Have not been adequately designed for intended use (unstable, poor structural integrity, 

electrical leakage, reusable but unable to thoroughly clean, etc.).

• Do not contain adequate directions or warnings.

• Are intended to be sterile but are non-sterile.

• Fail or deteriorate for any reason.

8.4.1.1.2 - Devices for Implant

Causes of injuries which may result from implanted devices include those listed in IOM 8.4.1.1.1. 

An injury or illness may also result because the materials used in the implant are not

biocompatible, thereby causing an adverse tissue reaction and/or deterioration of the implant. 

It is important to obtain information relating to a medical professional’s interpretation of the 

relations 

8.4.1.1.3 - In-Vitro Diagnostic Devices

In Vitro Diagnostics (IVD) are instruments that can include, gas chromatographs and automated 

blood analyzers, and much of the information under IOM 8.4.1.1.1 is applicable.

Injuries to patients from IVD products may be considered indirect, because they are due to 

complications resulting from misdiagnosis or delays in patient treatment due to incorrect test 

results. Examples of IVD failures include false positives, false negatives, and erratic results. Poor 

performance or failure may be due to poor manufacturing practices or user error.

Manufacturing problems include:

• Process errors and mix-ups (varying fill in kit components, improper ingredient addition, 

etc.).

• Labeling does not contain adequate directions or warnings or contains incorrect 

information.

• Labeling mix-ups.

• Contamination making the product unusable or causing misdiagnosis.

• User error due to poor directions for use, operator’s manual, or inadequacies in labeling 

requirements.

• Use of unclean, not maintained, or improperly calibrated equipment.

• Improper storage or use of reagents.

For In Vitro Diagnostic devices determine:

1. How the results of the test are used; screening, therapeutic drug monitoring, 

epidemiological information, monitoring the course of a disease, etc.

2. The role in overall determination of patient clinical care.
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8.4.2 - Confidential Informants 

FDA may receive external complaints that request their identity to be kept confidential or anonymous. 

In this case, the complainant’s information should not be disclosed in the investigation memorandum or 

EIR. The complaint should be assessed to determine if it is a non-injury/illness complaint or an 

injury/illness complaint as this may impact the urgency of the response. An immediate follow-up may be 

warranted if there is illness, injury, or if directed by higher authority. All information should be obtained 

in the least intrusive, yet constructive, manner that allows the investigator to collect the evidence 

required to evaluate the validity of the complaint to determine if additional action is warranted.

8.4.3 - Complaints

FDA may receive information from various sources, such as a consumer, whistleblower, employee, other 

governmental agency, Congress, or competitor alleging a potential violation of the FD&C Act that must 

be followed up to confirm the information provided by the complainant. For medical devices, a 

complaint means any written, electronic, or oral communication that alleges deficiencies related to the 

identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is 

released for distribution. 

As with all investigation types, report your findings in a memorandum and include all pertinent 

information and any attachments collected as evidence to support the complaint. Using eNSpect, create 

an operation 13, domestic investigation, or operation 15, foreign investigation, and complete all 

required fields. Upload all labeled attachments and submit for endorsement by your supervisor. Ensure 

the endorsement section includes verbiage to share the information with the divisional consumer 

complaint coordinator for appropriate follow-up in FACTS and completion of any other required 

documents for domestic complaints. If foreign, ensure the center is notified of the investigation and 

receives a copy of the investigation memorandum and any attachments.

If the complaint is an adverse reaction to a device, advise the complainant to visit FDA.gov, specifically 

the MedWatch Online Voluntary Reporting Form (fda.gov) to complete an FDA 3500, Medwatch Form; 

https://www.accessdata.fda.gov/scripts/medwatch/index.cfm (See IOM Exhibit 8-7) and discuss the need 

to have physician complete the form for submission. If the physician will not cooperate by completing

the FDA-3500, request the complainant to do it. Note in the "Remarks" section of the FACTS Consumer

Complaints Report that the FDA 3500 was forwarded to the complainant. 

8.4.4 - Reporting

The Medical Device Reporting (MDR) regulation and the changes mandated by the Safe Medical Devices 

Act of 1990 (SMDA) is a mandatory information reporting system. It requires manufacturers, importers, 

and device user facilities to report to FDA certain adverse experiences caused or contributed to by their 

devices. 

This program is administered by the Center's MDR Policy Team in the Office of Regulatory Programs.
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The regulation requires a report be submitted to FDA whenever a manufacturer or an importer becomes 

aware of information that its device: 1. May have caused or contributed to a death or serious injury, or 

2. Has malfunctioned and this device or a similar device would be likely to cause or contribute to a death 

or serious injury, if the malfunction were to occur.

Under the Safe Medical Devices Act of 1990, user facilities must report device-related deaths to FDA and 

to the manufacturer, if known. User facilities must also report device-related serious illnesses and injuries 

to the manufacturer, or to FDA if the manufacturer is unknown. In addition, SMDA also requires user 

facilities to submit to FDA, on an annual basis, a summary of all reports submitted.

The CDRH Division of Industry and Consumer Education (DICE@fda.hhs.gov) and the MDR Team 

(MDRPolicy@fda.hhs.gov) in the Office of Regulatory Programs should be contacted for further guidance 

about the MDR regulation.

As of August 2018, the agency’s Voluntary Malfunction Summary Reporting program was implemented. 

It permits certain manufacturers an alternative method to submit MDRs for eligible product codes in 

summary form on a quarterly basis; see 83 FR 40973. 

8.4.5 – Medical Device Sampling 

Obtain CDRH and WEAC concurrence prior to collecting any medical device samples.
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8.5 - Biologics Investigations 

8.5.1 - Illness/Injury

Reactions or symptoms of illness may occur in association with the administration of vaccines and other 

biological products. The Center for Biologics Evaluation and Research (CBER) is interested in all 

unexpected clinical responses to a biological product, as well as any expected responses of unusual 

frequency or severity. In some cases, a reaction or illness could occur because the product may: 

• Vary from declared potency. 

• Have been contaminated during manufacturing, shipment, or after shipment. 

• Be mislabeled. 

• Not have been given according to directions. 

• Not have been stored under proper conditions. 

• Have been provided to the wrong person. 

• Contain substances innocuous to most people, but which the recipient is unable to tolerate 

(e.g., anti-Kidd, anti-Duffy), or contains substances not usually present in such a product which 

stimulate an adverse response in the recipient (e.g., HLA antibodies). 

8.5.1.1 - Reporting

8.5.1.1.1 - Investigation/Reporting

When a biologics reaction/injury complaint is received by a CSO or consumer complaint 

coordinator, they should forward the complaint to ORABIOBiolgicsInspectionsPOC@fda.hhs.gov. 

All complaints received by the ORA BIO Biologics Inspection POC will be reviewed and upon 

determination of initial follow-up status sent to the district consumer complaint coordinator to 

be recorded on the FACTS Consumer Complaint Report. When interviewing the complainant

about a biologics complaint /injury, obtain: 

• Complete description of the complaint/injury. 

• Onset and duration of the reaction/injury. 

• Name of product administered, include date and time of administration. 

• Manufacturer and lot number of product(s), if available. 

At this point, it is generally unnecessary to conduct interviews beyond the complainant, or 

obtain records, until a preliminary review has been conducted. It is important to rapidly 

communicate the basic information about the incident, implicated product, lot, license 

number, manufacturer, and presence of intact units to the ORA BIO Biologics POC email. 

Confidential complaints received during an inspection should be captured in a memorandum as 

an attachment to the EIR. The confidential informant information should not be referenced in 

the EIR. Any findings related to complaints not involving confidential informants should be 

documented in the narrative to the EIR. The complaint number for all complaints should be 

written in the EIR coversheet in eNSpect. Complaint follow-up assignments will be issued in 

eNSpect as determined by OBPO. 
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If a complaint related to a vaccine product involves an adverse reaction of any kind, then a 

Form VAERS-1 (IOM Exhibit 8-6) should be completed online by complainant or their physician. 

If they cannot complete the form online, the VAERS Reporting Form can be mailed to them and 

they can send it to the address on the form. When you send a VAERS form to a complainant, 

note this fact in the Remarks Section of the FACTS Consumer Complaint Report. 

The Vaccine Adverse Event Reporting System (VAERS) is administered under a joint FDA/CDC 

contract. For reporting adverse events which occur subsequent to vaccine administration, the 

system utilizes a fillable online form (Form FDA VAERS 2.0) or can be directly submitted at: 

https://vaers.hhs.gov/reportevent.html See IOM Exhibit 8-6. 

8.5.1.1.2 - Professional Reporting System for Vaccine Adverse Reactions 

The National Childhood Vaccine Injury Act of 1986, 42 USC 201, was passed to achieve optimal 

prevention of childhood infectious diseases through immunization. At the same time, it was 

intended to minimize the number and severity of adverse reactions to vaccines routinely 

administered to children. This law requires health care providers and vaccine manufacturers to 

report certain adverse events which occur following the administration of specific vaccines. The 

vaccines and reportable events are listed in the National Childhood Vaccine Injury Act Vaccine 

Injury Table. The Department of Health and Human Services (DHHS) has established a Vaccine 

Adverse Events Reporting System (VAERS) to accept all reports of suspected adverse events 

after the administration of any vaccine, in all age groups, including but not limited to those in 

the table.

If the complaint does not involve an adverse reaction, obtain the necessary information to allow 

the center to make an informed decision on follow-up at the manufacturer. 

If the complaint is an adverse reaction to a biologics device, drug, or HCT/P product, an FDA 

3500, MedWatch Form (See IOM Exhibit 8-7) must also be completed and forwarded to the 

complainant for completion by their physician. If the physician will not cooperate by completing 

the FDA-3500, request the complainant to do it. Assist the complainant in completing the FDA 

3500, if necessary. Note in the "Remarks" section of the FACTS Consumer Complaints Report

that the FDA 3500 was forwarded to the complainant. MedWatch forms can be found at 

https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safetyreporting. 

If the complaint does not involve an adverse reaction, obtain information necessary to permit 

OBPO make an informed decision on follow-up at the manufacturer. If a complainant desires 

further information, refer them to CBER, Office of Biostatistics and Epidemiology, Division of 

Epidemiology, at 301-827-3974. 

If a CSO finds that there is a complaint of a fatality where blood or a blood component is 

implicated and that was not already reported to CBER, the CSO should notify their supervisor. 

The supervisor will then follow-up with OBPO management and CBER. Reporting a fatality is 

required of the collecting facility, in the event of a donor reaction, and by the facility which 
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performed the compatibility tests, in the event of a transfusion reaction. An investigation of the 

incident shall be conducted by either Healthcare Finance Administration (HCFA) Centers for 

Medicare and Medicaid Services (CMS) or FDA, based on the type of facility involved, for 

example, transfusion service, blood bank, plasma center or hospital. OBPO CSOs may be 

assigned to investigate a fatality through an assignment from CBER.

CSOs should follow OBPO’s procedure as a guide for conducting the investigation. The CSO 

should also refer to the eNSpect assignment for additional information regarding the 

investigation. If the hospital, medical examiner, or other entity either refuses to provide or 

requires a written request in order to provide the CSO with medical history records, a death

certificate, autopsy report, or other needed records, the CSO should complete and provide the 

firm with the Records Request Letter, that is referenced in OBPO’s procedure.

8.5.2 - Surveillance 

OBPO CSOs should review OSAR Firm 360 to determine if an existing complaint exists in preparation for 

conducting an inspection assignment. The CSO will review all firm information in OSAR Firm 360, 

including reviewing all complaints and address all complaints that do not have entries under follow-up 

disposition and follow-up disposition dates during the inspection assignment. CSO conducts the 

establishment inspection and investigates those issues identified in the complaint(s) and includes 

observations in the complaints and summary sections in the narrative of the EIR.

8.5.3 - Confidential Informants 

In addition to this section, please refer to the general section on Confidential Informants (Section 

8.1.7.2.3). Complaints can originate from public sources, including establishment employees at firm’s 

we inspect, donors, donor family members, and industry. Confidential complaints can also come 

through CBER and through other agencies. If the complaint is from a confidential informant, the 

complaint is NOT documented in the EIR. Confidential Informant complaints are documented in an 

Investigation Memo and saved as an attachment to the EIR. Findings are considered in the initial 

classification of the inspection.

8.5.4 - Complaints

8.5.4.1 - BIOLOGICAL PRODUCTS

OBPO CSOs should follow the OBPO procedure on oversight of consumer complaints. If any ORA 

office receives a complaint on a biological product, regardless of licensure status, the receiving office 

will notify OBPO at ORABIOBiologicsInspection@fda.hhs.gov. OBPO will provide direction on how to 

proceed, and next steps, including instructions on any FACTS entries. For additional information or 

inquiries, send an email to the inspection POC address above or contact either of the OBPO division 

directors. OBPO staff receiving a complaint from external or internal sources should send the 

complaint to ORABIOBiologicsInspection@fda.hhs.gov. Confidential complaints received during an 

inspection should be captured in a memorandum as an attachment to the EIR. The confidential 

informant information should not be referenced in the EIR. 
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Any findings related to complaints not involving confidential informants should be documented in 

the narrative to the EIR. The complaint number for all complaints should be written in the EIR 

coversheet in eNSpect. Complaint follow-up assignments will be issued in eNSpect as determined by 

OBPO.

8.5.4.2 -Biological Samples

Do not collect samples of a suspect product without first consulting with the supervisor. An 

evaluation of the preliminary information on the injury/reaction by CBER (for licensed products) 

and/or the home district division (for unlicensed products, plasma and blood products) may be 

necessary to determine if a sample should be collected.

8.5.4.3 - BIOLOGICS INJURY/ADVERSE REACTION REPORTS 

Submit biologics injury and adverse reaction narrative reports using encrypted email or mailing. If 

mailing, use this address: 

Food and Drug Administration 

White Oak Bldg71 

10903 New Hampshire Avenue 

Silver Spring, MD 20993-0002 

NOTE: In addition, check the “Notify EO/EOMPS?” box in FACTS for all injury and adverse reaction

complaints. For serious injury/illness reports, please notify the OEM/OEO immediately at 1 (866)

300-4374 and emergency.operations@fda.hhs.gov. 
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8.6 - Bioresearch Monitoring Investigations 

8.6.1 - Illness/Injury

8.6.1.1 - Reporting

Submit drug complaints and injuries to:

MedWatch

The FDA Medical Products Reporting Program (HFD-410)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857

Fax Number: 1-800--322-0178

8.6.2 - Surveillance

For Cause assignments issued to OBIMO may require interviewing of subjects to verify their 

participation in the clinical trial. These activities would be conducted with supervisor approval. An OP13 

(or OP15 for foreign) will be created in eNSpect, for the purpose of subject interviewing, with 

information correlating the OP12 (or OP11) For Cause assignment. An investigational memo will be 

uploaded as an “Attachment” as per Section 8.1.9 General Investigation Reporting. Additionally, the 

investigational memo will be included in the EIR as an “Attachment.”

8.6.3 - Complaints

Complaints are received via assignment memo from the respective center. The memo will have specifics 

about the complaint and any special instructions. Reporting of complaints are the same as an inspection 

via an EIR unless otherwise instructed (see section regarding For Cause/Fact Finding/Information 

Gathering above). See IOM 5.10.2 – BIMO Assignments as complaint information will be included in the 

overarching assignment memo.
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8.7 - Tobacco Investigations 

8.7.1 - Investigations Coordination

Tobacco Products Samples: When collecting tobacco product samples as a result of a product complaint

or adverse report investigation, see IOM 4-24, for sample collection guidance and contact CTP’s Office of 

Compliance and Enforcement. (extract from IOM 8.4.7.6)

8.7.2 - Complaints

Anyone who encounters a problem with a tobacco product, such as a safety issue or undesired health 

problem, may report it online via the FDA Safety Reporting Portal (SRP) at www.safetyreporting.hhs.gov. 

Anyone may report a health problem and /or product defect involving a tobacco product using the FDA 

Safety Report Portal. www.safetyreporting.hhs.gov. 

Potential tobacco product violations include (but are not limited to):

• Sales to minors.

• Flavored cigarette sales.

• Illegal marketing and advertising – The Tobacco Control Act gives the FDA the ability to regulate 

certain marketing and advertising activities by the tobacco industry, including

describing tobacco products as “light,” “mild,” or “low” – or claiming a product is safer or less 

harmful without an FDA order.

• Distributing t-shirts or other promotional or novelty items with brand names of cigarette or 

smokeless tobacco products. 

• Sponsoring events using the brand name of a tobacco product.

• Distribution of free samples of tobacco products except in limited circumstances. 

• Placement of cigarette or smokeless tobacco product vending machines in prohibited areas (or 

providing access to self-service or direct access of tobacco products in prohibited areas). 

• Sale of cigarettes in packages of less than 20. 

If you see what you believe to be a violation of the Tobacco Control Act or other related regulations, you 

can:

• Submit online (https://www.accessdata.fda.gov/scripts/ptvr/index.cfm)

• Call the Tobacco Call Center using CTP's toll-free number: 1.877.CTP.1373

• Send an email: CTPCompliance@FDA.hhs.gov

• Print and mail:

Paper form (Form FDA 3779, Potential Tobacco Product Violations Report) 

(https://www.accessdata.fda.gov/scripts/ptvr/index.cfm) to: 

Potential Tobacco Products Violation Report

Food and Drug Administration

Center for Tobacco Products

Office of Compliance and Enforcement

Document Control Center

Building 71, Room G335
CHAPTER 8 INVESTIGATIONS OPERATIONS MANUAL 2023

8-64

10903 New Hampshire Avenue

Silver Spring, MD 20993
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 8-1

8-65

EXHIBITS

8-1 FEDERAL ANTI-TAMPERING ACT FULL LANGUAGE 
EXHIBIT 8-2 INVESTIGATIONS OPERATIONS MANUAL 2023 

8-66

8-2 LETTER TO HEALTHCARE PROVIDER FOR MEDICAL RECORDS

To access the word document, click here. Note: Link to the Letter to Healthcare Provider for Medical 

Records is only available to ORA users on the FDA intranet. The link is

http://qmis.fda.gov:80/mc/main/index.cfm?event=showFile&ID=OMIJZHPT3ZE7FJRCSJ&static=false&mc

uid=ANONYMOUS&mcsid=FPSFER5OBBABVCT55K. Users who need a copy of the template outside FDA 

should use the Freedom of Information Process described in Section 8.1.3 to get a copy of the template. 
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 8-3 

8-67

8-3 INVESTIGATION MEMO 

To access the word document, click here. Note: Link to the Investigation Memo is only available to 

ORA users on the FDA intranet. The link is

http://qmis.fda.gov:80/mc/main/index.cfm?event=showFile&ID=C7ZQFEQOANEQ5JXMLX&static=false&

mcuid=ANONYMOUS&mcsid=AQZ6DL5KXFHKBPWISH. Users who need a copy of the SOP outside FDA 

should use the Freedom of Information Process described in Section 8.1.3 to get a copy of the SOP.

 
EXHIBIT 8-4 INVESTIGATIONS OPERATIONS MANUAL 2023 

8-68

8-4 TABLE OF INCIDENT COORDINATION

Incident Type Coordinating Body Points of Contact (POCs)

Clusters and outbreaks of 2+ 

human illnesses

CFSAN / CORE

(Coordinated Outbreak

Response and Evaluation 

Network)

CORE Signals Team, 

CORESignalsTeam@fda.hhs.gov

Single human illness (this 

includes single case 

retrospective incidents but 

also individual consumer 

complaints) 

CFSAN / OC 

(Office of Compliance) 

CFSANOCSRT@fda.hhs.gov

Clusters and outbreaks of 

human illness due to pet 

food/feed products

CVM

(Center for Veterinary 

Medicine)

David.Rotstein@fda.hhs.gov, 

Mark.Glover@fda.hhs.gov 

Allergen issues (any and all) CFSAN / OC

(Office of Compliance)

Stefano.luccioli@fda.hhs.gov

Seafood toxin incidents*

(All toxins; All domestic and 

international waters)

CFSAN / OFS / DSS

(Division of Shellfish Safety 

and DSST, Division of Seafood 

Science and Technology)

Ronald.Benner@fda.hhs.gov

Jonathan.Deeds@fda.hhs.gov

Karen.Swajian@fda.hhs.gov

Molluscan shellfish outbreaks

(single and multiple human 

illnesses) 

CFSAN / OFS / DSS

(Division of Shellfish Safety 

and DSST, Division of Seafood 

Science and Technology)

Melissa.Farrell@fda.hhs.gov (goes 

by Lizzie; OFS / DSS)

Melissa.Abbott@fda.hhs.gov (OFS / 

DSS)

Jessica.Jones@fda.hhs.gov (OFS / 

DSST)

Processed shellfish outbreaks

(e.g., non-molluscan shellfish 

(crustaceans such as lobster, 

crab, crab meat, crawfish, 

shrimp, and processed 

molluscan shellfish))

CFSAN / CORE

(Coordinated Outbreak

Response and Evaluation 

Network)

CORE Signals Team, 

CORESignalsTeam@fda.hhs.gov

Kratom-related / CBD / 

psychoactive substance 

incidents

OC / OO / OSEM / OEM / OEO

(Office of Emergency 

Operations)

FDA Emergency Operations list: 

emergency.operations@fda.hhs.gov

Hepatitis A positive samples

(and subsequent coordination 

with CDC for PEP); no known 

associated HAV illnesses

FDA Liaison to CDC FDA Liaison to CDC

(Susan.Lance@fda.hhs.gov) 
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 8-4 

8-69

Infant illnesses* (Salmonella,

Cronobacter, infant botulism 

with rule-out investigations for 

infant formula or related 

infant products such as gripe 

water or medicated foods)

CFSAN / OC 

(Office of Compliance) - 

Powdered Infant Formula (PIF)

CFSAN / ONFL

(Office of Nutrition and Food 

Labeling)

NCCC

National Consumer Complaint

Coordinator

OC contact for PIF is 

Marjorie.Davis@fda.hhs.gov 

ONFL contact for infant formula are 

Andrea.Lotze@fda.hhs.gov and 

Carrie.Assar.@fda.hhs.gov 

NCCC in OEO is 

Joan.Trankle@fda.hhs.gov 

Disasters (Natural and 

Manmade)

OC / OO / OSEM / OEM / OEO

(Office of Emergency 

Operations) 

FDA Emergency Operations list: 

emergency.operations@fda.hhs.gov

Food Defense incidents 

(Intentional Contamination)

OC / OO / OSEM / OEM / OEO

(Office of Emergency 

Operations)

And

CFSAN / OAO

(Office of Analytics and

Outreach)

CFSAN/OAO/Food Defense and 

Emergency Coordination Staff 

contact is 

Leeanne.jackson@fda.hhs.gov 
EXHIBIT 8-5 INVESTIGATIONS OPERATIONS MANUAL 2023 

8-70

8-5 CIFOR OUE Agent List 

AgentName Median Incubation

Period (Range)1

PrimarySignsand

Symptoms

Primary

Specimen(s)

KEI§-Special

group(s)

KEI-Geographic

Considerations

KEI-Notable

Exposures

BACTERIAL

Arcobacter butzleri 32 hrs (6-83 hrs)2 D (persistent and watery),

abdominal cramps, N, V

Stool in Cary-Blair,

raw stool

Bacillus anthracis Usually ≤1 week (Up

to 60

days)

Severe abdominal pain, N, V,

fever, D (may be bloody),

ascites, sepsis, meningitis

Blood, stool in CaryBlair, raw stoolRecenttravel to

endemicareas,

tropical orsubtemperate

regions

Undercooked meat 

or hides of

herbivores

Bacillus cereus, diarrheal

toxin

10-16 hours (6-24

hours)

Abdominal cramps, D

(watery), N

Stool in Cary-Blair,

raw stool

Time and/or

temperatureabused foods

Bacillus cereus, pre-formed

toxin

30 min- 6 hours Sudden onset ofsevere N, V,

D

Stool in Cary Blair Time and/or

temperatureabused foods

Brucella spp. 3-4 weeks (1 week to

severalmonths)

Flu-like symptoms including 

fever, chills,sweating, HA, 

joint pain, weakness; may

cause recurrent fevers and 

chronic joint pain/fatigue;

may cause diarrhea and

bloody stoolsin acute phase

Blood,serum Animal

handlers,

especially farm

workers and

veterinarians

Ingestion of raw

milk and dairy

products

Campylobacterspp. 2-5 days (1-10 days) D (may be bloody),

abdominal cramps, Fever, 

possible N & V, GuillainBarreSyndrome3

Stool in Cary Blair,

raw stool

Undercooked or raw

meat or poultry; 

raw milk/ milkproducts

Clostridium botulinum,

foodborne£

12-72 hours (6 hours10

days)

V, D, blurred vision, diplopia,

dysphagia, "bilateral"

descending muscle 

weakness, cranial nerve

palsies (e.g., blurred vision,

diplopia, dysphagia)

Raw stool,

vomitus or

serum

(specimens

collected priorto

anti- toxin

administration)

Improperly

processed and

canned foodsin

airtight

containers/packagin

g

Clostridium botulinum,

infantile£

3- 30 days Lethargy, weakness, poor 

feeding, constipation,

hypotonia, poor head

control, poor gag reflex and

sucking reflex

Raw stool,serum Infants Honey; home 

canned vegetables,

fruits; corn syrup

Clostridium perfringens 8-16 hours (6-24

hours)

D (watery), abdominal 

cramps, N;

feverisrare

Stool in CaryBlair, raw stool

Time and / or

temperature

abused foods

Cronobactersakazakii

Lessthan 28 days

Bacteremia,meningitis,

necrotizing enterocolitis

Blood, stool in

Cary- Blair, raw

stool

Premature

infants

Infantformula

Coxiella burnetii (Acute Q

fever)

2-3 weeks (3-39 days) Fever, HA, fatigue, malaise,

cough, anorexia, N, V, D,

abdominal pain, pneumonia

Blood with EDTA/

serum,tissue

Pregnant

women,

immunosuppr

essed, and

patients with a

pre-existing

heart valve

defects

Consumption of raw

cow or goat milk; 

contact with cows

or goats

Enterohemorrhagic E. coli

(EHEC) (including Shiga-toxin

producing E. coli (STEC) and

Verotoxin producing E. coli

(VTEC))

3-4 days (1-10 days) D (often bloody), abdominal

cramps, V, hemolyticuremic syndrome (HUS)

Stool in CaryBlair, raw stool

Young children Consumption of raw

milk; contact with 

cattle/ruminants; 

undercooked

ground beef; leafy

greens

Enterotoxigenic E. coli

(ETEC)

24-72 hours (10

hours- 6

days)

D (profuse watery),

abdominal cramps, V 

Stool in CaryBlair, raw stool

Foreign travel

especially to

Contaminated water

and food sources
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 8-5 

8-71

developing

countries

Enteroinvasive E. coli (EIEC) As short as 10-18 hrs D (watery), fever, abdominal

cramps, dysentery (in rare

cases)- scant stools w/

evidence of blood, mucous

or leukocytes in stool

Stool in CaryBlair, raw stool

Foreign travel

especially to

developing

countries

Enteropathogenic E. coli

(EPEC)

As short as 9-12 hrs D (watery with mucous),

fever, V 

Stool in CaryBlair, raw stool

Children < 2

years of age

Enteroaggregative E. coli

(EAEC)

Estimated at 20-48 

hrs

Chronic or acute D (watery),

V 

Stool in CaryBlair, raw stool

Diffuse-Adherence E. coli

(DAEC)

D Stool in CaryBlair, raw stoolYoung children

Leptospira interrogans 5-14 days (2-30 days) Anicteric disease (no liver

involvement)- Abrupt onset

of fever, HA, abdominal

pain, N, V, severe myalgia,

malaise, conjuctival

petechiae and/or

hemorrhage Icteric disease

(liverinvolvement)-

Jaundice, upperright

quadrant pain, N, V, 

decreased urine output,

edema, hemorrhage,

vascular collapse,severe

alteredmental status(AMS)

Blood, CSF,Urine Farmers,

veterinarians,

slaughterhous

eand sewer

workers

Water activities

(swimming,

kayaking)

Listeriamonocytogenes 1 day- 3 weeks (3-70 

days)

Invasive diseaseSevere HA, N, V,stiff

neck, confusion, and 

other neurological

symptoms consistent

with meningitis,sepsis,

bacteremia, premature

birth orstillbirth

Gastrointestinal diseaseFever,D, myalgia

Blood, CSF, Stool

in Cary-Blair

Pregnant

women€, 

immunosuppr

essed¥, 

elderly¥

Raw milk/dairy; soft

cheeses; deli or RTE

meats, raw produce

Mycobacteriumbovis Undetermined Gastrointe

stinal

diseaseAbdominal

pain, D

Lung disease- Fever, weight

loss, nightsweats, cough

Stool in CaryBlair, sputum

Foreign born,

immigrants,

immunocompr

omised, dairy

workers

Raw milk/milk 

products; contact 

with cattle, bison, 

elk and deer

Salmonella spp. (non-typhi) 12-36 hours (6- 72 

hours)

D (can be bloody) fever,

abdominal pain, N, V 

Stool in CaryBlair, raw stool

Salmonella Typhi/

Paratyphi

Typhi- 7-14 days (3-

60+

days)

Paratyphi- 1-10 days

Fever, HA, malaise, chills,

myalgia, weight loss,

constipation or D,

bacteremia,rash, cough

Stool in CaryBlair, raw stoolRecenttravel to

endemic areas;

Africa,

Southeast Asia

Contaminated water

and food sources

Shigella spp. 24-72 hours (1-7 

days)

D (stools can have blood and

mucus), abdominal cramps,

fever, V, tenesmus

Stool in CaryBlair, raw stool

Young children Usually person to

person,

water or raw milk

Staphylococcus aureus

(preformedtoxin)

1-6 hrs (30 minutes8hrs)

SevereN, V, abdominal

cramps, prostration, D, drop

in blood pressure

Stool in CaryBlair, raw stool

Foods handled with

bare hands

especially those

without further

cooking or 

inadequate

heating/

refrigeration,time

and / or

temperature abused

foods
EXHIBIT 8-5 INVESTIGATIONS OPERATIONS MANUAL 2023

8-72

Streptococcus, Group A 1-5 days Sore throat (pharyngitis,

tonsillitis), fever,malaise,

rash, cellulitis

Throatswab Milk/ raw milk, 

eggs, raw

produce

Vibrio parahaemolyticus 12-24 hours (2-96 

hours)

D (watery), N, V, abdominal

cramps, HA, fever, chills; 

Wound infections are

possible

Stool in CaryBlair, blood,

wound culture

Immunocompr

omised, preexisting liver

conditions

Coastal, 

brackish

waters,

estuaries

Raw or 

undercooked

seafood (oysters,

clams,squid,

mackerel, tuna, 

sardines, crab,

shrimp)

Vibriovulnificus 24-72 hours (1-7 

days)

V,D, abdominal pain, wound

infections, bacteremia,

shock

Stool in CaryBlair, blood,

wound culture

Immunocompr

omised, preexisting liver

conditions

Coastal, 

brackish

waters,

estuaries

Raw or undercooked seafood

(oysters, clams,

squid, mackerel,

tuna, sardines,

crab,shrimp),

contaminated

water, open wounds.

Vibrio cholerae, toxigenic 24-72 hours (few

hours to

5 days)

D (profuse watery),

abdominal

cramps, N, V, dehydration,

shock

Stool in CaryBlair, rectalswab

Immunocompr

omised, esp.

pre-existing

liver

conditions

Coastal, 

brackish waters,

estuaries esp.

Pacific

Northwest

Seafood, raw or 

under-cooked

oysters,

contaminated water

Recenttravel to

endemic areas

Yersinia enterocolitica 3- 7 days (1-14 days) Fever, abdominal pain, D, V Stool in Cary-Blair,

raw stool; blood

Children and

elderly more

susceptible

Undercooked pork

products, raw milk

Yersinia pseudotuberculosis 3- 7 days (1-14 days) Fever, abdominal pain, D, V,

(can have scarlatiniform

rash)

Stool in Cary-Blair,

raw stool; blood

Males

FUNGAL

Cryptococcus 2 to 14 months (C.

gattii)

D, abdominal cramps CSF, serum Immunocompr

omised

Pacific

Northwest,

Australia,Africa

Inhalation

PARASITIC

Angiostrongylus cantonensis

or A. costaricensis

1-3 weeks (1 day- 6 

weekscantonensis); weeks1

year(costaricensis)

Severe HA, N, V,stiff neck, 

and other neurological

symptoms consistent with

meningitis(A. canontensis);

Abdominal pain, fever, N, V

(A. costaricensis)

CSF, blood,serum Texas, Pacific

Basin, SE Asia

(A.

cantonensis);

Latin

America,

Caribbean (A.

costaricencis)

Raw/undercooked

snails, slugs; 

chopped vegetables

contaminated with

infected snails or

slugs

Cryptosporidium 7 days (1-14 days) D (severe watery; may be 

recurrent),

abdominal cramps, N, fever

Stool (2-3

samples

collected over

several days)

Recreational water,

drinking water,

unpasteurized milk,

contact with cattle,

children in daycare

settings(fecal-oral

transmission)

Cyclospora cayetanensis 7 days (1-14 days) D (watery), weight loss,

anorexia, abdominal 

cramps, N, V and fatigue;

feverrare

Stool, intestinal

fluid,

tissue biopsy

More common 

in tropical and 

subtropical

countries, but

occursin

other areas due

tocontaminated

imported

produce

Fresh fruit and

vegetables (e.g.

berries, basil, snow

peas, lettuce),

contaminatedwater

Entamoeba histolytica 1-4 weeks (from a few

days

to several months or

years)

Fever, chills, lower

abdominal pain, D, bloody

D (amoebic dysentery), liver

(or other organ) abscess

Stool (2-3

samples over

several days),

blood if

Invasive

amoebiasis

more common

in young

adults, liver

Tropical

countries with

poorsanitation

(South and

Central

Human reservoir,

fecally

contaminated food

or water; person-topersonless common
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 8-5

8-73

disseminated abscessmore

common in

males,

dysentery rare

before age 5

America, Africa,

and Asia)

Giardia lamblia 1-3 weeks (3 days- 3

weeks)

D, abdominal cramps,

greasy stools, gas

Stool (2-3

samples

collected over

several days)

Drinking water,

recreational water,

children in daycare

settings(fecal-oral

transmission); 

occasional food

contamination

Toxoplasma gondii 7 days (4-23 days) Cervical lymphadenopathy,

flu-like illness; if 

immunocompromised,

central nervoussystem

(CNS) disease,myocarditis,

or pneumonitis can occur

Serum Raw beef

Trichinella spiralis GI symptoms- 1-2 

days;

5 days- 8 weeks for

other

symptoms

Muscle soreness

accompanied by fever

and edema of eyelids

are characteristic;

eosinophilia, N, V,

chills, D, abdominal cramps,

fatigue

and weakness possible

Serum; biopsy of

tissue

Consumption ofraw

or undercooked

meat (particularly 

bear, pork, wild

feline, fox, dog, wolf,

moose, horse,seal

or walrus)

VIRAL

Adenovirus 1-10 days D (prolonged), N, V,HA,

fever, malaise, abdominal 

pain; Types 40 and 41 can 

cause GI outbreaks

Stool in CaryBlair, raw stool,

serum, nasopharyngeal

swab,

Children

Astrovirus 1-4 days D (watery), N, V, fever,

malaise, abdominal pain,

HA, anorexia

Stool in CaryBlair, raw stool,

serum

Children and

immunocompr

omised

Child care facilities,

long-term care

facilities

Hepatitis A 28 days (15-50 days) Jaundice, dark urine, 

fatigue, anorexia, N, D,

fever, HA, abdominal pain,

weight loss

Stool in CaryBlair, raw stool,

Serum

Men who have

sex with men,

injection drug

users,

international

adoptees

Foreign travel Water

contaminated

with infectious

human waste;

raw, undercooked

mollusks

harvested from

contaminated

waters

Hepatitis E 26-42 days (15- 64 

days)

Jaundice, dark urine, D, 

fever, abdominal pain,

arthralgia, rash,

hepatomegaly, altered

consciousness

Stool in CaryBlair, raw stool,

Serum

Foreign travel,

especiallyAsia,

Middle East,

Africa and 

Central 

America; 

exposure to pigs

Contaminated

drinking water;

oysters,

mussels and

other shellfish;

pork, pig liver;

and raw/rare

deer and boar

Norovirus 12-48 hours (10- 50 

hours)

N, V,D, abdominal cramps,

fever (low grade), HA,

myalgia, malaise

Stool in CaryBlair, raw stoolInstitutionalize

d populations

Parvovirus(Human

Bocavirus, HBoV 2-4)

Unknown- emerging

pathogen

D, V, fever, abdominal pain,

coryza, cough

Stool in CaryBlair, raw stool,

serum, CSF

Children

Rotavirus 1-3 days D (watery), V, fever(low

grade), abdominal pain

Stool in CaryBlair, raw stoolChildren

Saffold virus(SAFV) Unknown-emerging

pathogen

D, V, respiratory symptoms

(children); if invasive, then

Stool in CaryBlair, raw stool,Children
EXHIBIT 8-5 INVESTIGATIONS OPERATIONS MANUAL 2023

8-74

meningitis, encephalitis,

myelitis, myocarditis,

enanthema, exanthema,

septicemia

naso- pharyngeal

swab, CSF

Sapovirus 12-48 hours N, V, D, abdominal pain,

fever, HA, myalgia

Stool in CaryBlair, raw stoolInfants, young

children and

institutionalize

d populations

(esp. longterm care

facilities)

OTHER

Brainerd D agent Unknown D (Profuse, watery,

prolonged 2-36 months)

Stool in CaryBlair, raw stool

Toxins

Azaspiracid Poisoning (AZP) 12-24 hours N, V,D, abdominal cramps Shellfish,toxin

detection

Europe Mussels,

oysters

Carchatoxin < 1-6 hours N, V,D, and paresthesias Food Madagascar Shark,

particularly 

the liver

Ciguatera toxin GI symptoms- 1-6 

hours (few minutes48 hours) Neurologic

symptoms- few

minutes- 48 hours

N, V,D, abdominal cramps,

sweating,HA, muscle aches,

paresthesia of lips, tongue,

face or extremities and

temperature sensation

reversal(hot/cold sensation

flip)

Fish for

purification/

extraction and

mouse bioassay

Tropicalareas Predatory fish

like barracuda,

grouper,sea

bass,snapper,

mullet

Scombroid Fewminutes- 3 hours Rash, D, flushing, sweating,

HA, V, burning/tingling

sensation in mouth,

swelling in mouth,

abdominal pain and

metallic taste

Fish, histamine

testing

Fish such as

tuna and

mackerel;

(bacterial

action in)

Swiss cheese

Tetrodotoxin < 30 minutes Paresthesia of lips,

tongue, face or

extremities often

following

numbness; floating

sensation,

V,D, abdominal pain,

ascending paralysis,

respiratory failure

Pufferfish, toxin

testing

Pufferfish

consumption

Mushroom toxin (shortacting)Fewminutes- 2 hours V,D, confusion, vision

problems, salivation,

diaphoresis, hallucinations

Mushrooms,

toxin detection

Mushroom

consumption

Mushroom toxin (longacting)4-24 hours D, abdominal cramps, liver

and

kidney failure

Mushrooms,

toxin detection

Mushroom

consumption

Shellfish toxin (diarrheic) 30 minutes- 2 hours N, V, D, abdominal pain,

chills, HA, fever

Shellfish,toxin

detection

Mussels,

oysters,

scallops from

Gulf of Mexico,

FL

Shellfish toxin (neurotoxic) Fewminutes- 3 hours Tingling and numbness of

lips, tongue and throat;

muscle aches, dizziness and

reversal of hot/cold

sensation, D, V

Shellfish,toxin

detection

Mussels,

oysters,

scallops from

Gulf of Mexico,

FL

Shellfish toxin (amnesic) < 24 - 48 hours V,D, abdominal pain and

neurologic symptoms of

confusion, memory loss,

disorientation,seizure or

coma

Shellfish,toxin

detection

Mussels,

oysters,

scallops
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 8-5

8-75

Shellfish toxin (paralytic

poisoning)

30 minutes- 3 hours 

(15

minutes- 10 hours)

N, V,D, paresthesia of

mouth and lips, weakness,

dysphasia, dysphoria,

respiratory paralysis

Shellfish or water,

toxin detection

Scallops,mussels,

clams,

cockles

Chemicals

Antimony <1 hour (5 mins- 8 

hours)

V,D, abdominal pain,

metallic taste

Food or beverage Metalliccontainer

Arsenic Few hours N, V,D, pins and needles

sensation, colic

Urine analysis

Cadmium <1 hour (5 mins- 8 

hours)

N, V, D, myalgia, increased

salivation, abdominal pain; 

often a metallic taste

Food Seafood, oysters,

clams, lobsters,

grains and peanuts

Chlorinatedhydrocarbon

insecticides(aldrin,

chlordane, DDT, endrin,

lindane,toxaphene)

30 minutes- 6 hours N, V, paresthesia, dizziness,

muscular weakness,

anorexia, weightloss,

confusion

Blood, urine,stools,

gastric washings

Storing insecticides

in same areas as 

foods; mistaking

pesticidesfor

powdered foods

Copper <1 hour (5 mins- 8 

hours)

N, V (blue or green), D; 

often a

metallic taste

Food or beverage Metalliccontainers

Mercury <1 week N, V, D, numbness, skin 

rash, eye irritation, 

weakness of legs, spastic

paralysis, impaired vision,

blindness, coma

Blood, hair Fish; grains treated

with

mercury containing

fungicides

Monosodiumglutamate

(MSG)

Few minutes to 1 

hour

Tingling, flushing, dizziness,

HA, N, burning sensation in 

back of neck, forearms;

feeling of tightness in chest

N/A Foodsseasoned

with MSG

Nicotinic acid/Niacin Few minutes to 1 

hour

Flushing,sensation of

warmth, itching, abdominal

pain, puffiness of face and 

knees

N/A Meats or other

foods with sodium

nicotinate as color

preservative; high 

doses of dietary

supplements

Nitrite poisoning 1-2 hours N, V, cyanosis/blue skin, HA,

dizziness, weakness, fatigue,

loss of consciousness,

chocolate-brown colored

blood

Blood, food Cured meats and

spinach

Organophosphatesor

carbamatepesticides

(Diazinon, Malathion,

Parathion, TEPP; Carbaryl,

Sevin®, Lannate®,

Aprocarb®)

Few minutesto few 

hours

N, V, abdominal pain, HA,

nervousness, blurred vision,

twitching, convulsions

Blood, food Spraying foodsjust

before harvesting; 

storing insecticides

in same areas as

foods; mistaking 

pesticides for

powderedfoods

Sodiumfluoride Few minutesto 2

hours

Irritation of skin, eyes, and

respiratory tract,salty or

soapy taste in mouth,

numbness of mouth, V,D,

dilated pupils, spasms, 

pallor, shock, collapse

Vomitus, gastric

washes and food

Dry goods 

(powdered milk,

flour, baking

powder, cake mix),

insecticides and

rodenticides

Thallium Few hours V,D, hair loss, neurologic

manifestations(paresthesia,

respiratorydepression,

bronchospasms, cranial

nerve palsies)

Urine, hair Centersfor

Disease Control

and Prevention.

Thallium

Poisoning from

Eating

Contaminated

Cake-- Iraq, 2008. 

MMWR. 

September 19,
EXHIBIT 8-5 INVESTIGATIONS OPERATIONS MANUAL 2023

8-76

Notes:

1 Unless otherwise noted, the median incubation period and range were obtained from the following three sources: Heymann, D.L.

(Ed.)(2008). Control of Communicable Diseases Manual (19th ed.). Washington, DC: American Public Health Association; Centers for 

Disease Control and Prevention (CDC) (March 26, 2014) A-Z Index for Foodborne Illness. Retrieved from

http://www.cdc.gov/foodsafety/diseases/index.html.

2 Victoria Lappi, John R. Archer, Elizabeth Cebelinski, Fe Leano, John M. Besser, Rachel F. Klos, Carlota Medus, Kirk E. Smith, Collette

Fitzgerald, and Jeffrey P. Davis. Foodborne Pathogens and Disease. March 2013, 10(3): 250-255. doi:10.1089/fpd.2012.1307.

3 B.R. Jackson, J. Alomia Zegarra, H. Lopez-Gatell, J. Sejvar, F. Arzate, S. Waterman, A. Sanchez Nunez, B. Lopez, J. Weiss, R. Quintero Cruz, D. 

Y. Lopez Murrieta, R. Luna-Gierke, K. Heiman, A. R. Vieira, C. Fitzgerald, P. Kwan,

M. Zarate-Bermudez, D. Talkington, V. R. Hill and B. Mahon (2014). Binational outbreak of Guillain–Barré syndrome associated with 

Campylobacter jejuni infection, Mexico and USA, 2011 . Epidemiology and Infection, 142, pp 1089-1099. doi:10.1017/S0950268813001908.

§- Key epidemiological information

£- Clinical consultation and testing recommendations(including lab collection recommendations) can be obtained through

consultation with CDC.

€- Pregnant women may be more likely to present with mild, flu-like symptoms.

¥- Elderly or immunocompromised may be more likely to present with sepsis or meningitis.

N- nausea, D- diarrhea, V-vomiting, HA- headache

2008 / 57(37);1015-

1018.

Tin Few hours N, V, D; often a metallic

taste

Food Metalliccontainer

Triorthocresylphosphate 10 days (5-21 days) N, V, D, leg pain, ungainly

high stepping gait, food and

wrist drop

N/A Using compound to

extract foods or as 

cooking or salad oil

Zinc Few hours Stomach cramps, N, V, D, 

myalgias;

often a metallic taste

Blood,stool,saliva,

urine and food

Metalliccontainer
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 8-6

8-77

8-6 – VAERS Form 
EXHIBIT 8-6 INVESTIGATIONS OPERATIONS MANUAL 2023

8-78
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 8-6

8-79
EXHIBIT 8-6 INVESTIGATIONS OPERATIONS MANUAL 2023

8-80
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 8-7 

8-81

8-7 MedWatch Form
EXHIBIT 8-7 INVESTIGATIONS OPERATIONS MANUAL 2023

8-82
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 8-7

8-83
EXHIBIT 8-8 INVESTIGATIONS OPERATIONS MANUAL 2023

8-84

8-8 Potential Tobacco Product Violations Form 
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 8-8

8-85
EXHIBIT 8-8 INVESTIGATIONS OPERATIONS MANUAL 2023

8-86
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 8-9 

8-87

8-9 – Disaster Response Flow Diagram
EXHIBIT 8-9 INVESTIGATIONS OPERATIONS MANUAL 2023

8-88
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 8-9

8-89
EXHIBIT 8-9 INVESTIGATIONS OPERATIONS MANUAL 2023

8-90
INVESTIGATIONS OPERATIONS MANUAL 2023 EXHIBIT 8-9

8-91
INDEX INVESTIGATIONS OPERATIONS MANUAL 2023

8-92

INDEX 

A

Adverse................ .8-5, 8-31, 8-40, 8-41, 8-42, 8-43, 8-44, 8-

45, 8-49, 8-50, 8-51, 8-56, 8-58

Alcohol.......................................................................... 8-48

B

Baby Food .............................................. 8-7, 8-8, 8-44, 8-48

C

CBER................................................... 8-55, 8-56, 8-57, 8-58

CFSAN .....................8-27, 8-31, 8-32, 8-33, 8-35, 8-40, 8-41, 

8-44, 8-45, 8-46, 8-47, 8-64, 8-65

Complainant..................8-5, 8-8, 8-9, 8-21, 8-23, 8-25, 8-26, 

8-41, 8-42, 8-44, 8-51, 8-53, 8-54, 8-55, 8-56

Complaint............8-4, 8-5, 8-7, 8-8, 8-9, 8-18, 8-20, 8-21, 8-

23, 8-24, 8-25, 8-29, 8-31, 8-36, 8-40, 8-41, 8-42, 8-44, 

8-45, 8-48, 8-49, 8-50, 8-51, 8-53, 8-54, 8-55, 8-56, 8-

57, 8-58, 8-59, 8-60, 8-64, 8-65

Complaints..............8-7, 8-8, 8-45, 8-48, 8-50, 8-51, 8-54, 8-

56, 8-57, 8-59, 8-60

Cooperation....................................... 8-30, 8-31, 8-38, 8-50

Counterfeit......................... 8-4, 8-17, 8-18, 8-19, 8-20, 8-21

Criminal Activity..................................... 8-4, 8-6, 8-19, 8-41

CVM ................................. 8-27, 8-31, 8-41, 8-45, 8-51, 8-64

D

Death .................................8-5, 8-7, 8-18, 8-19, 8-20, 8-23, 8-

40, 8-41, 8-44, 8-52, 8-57

Detention............................................................. 8-14, 8-15

Disaster..............8-4, 8-9, 8-10, 8-11, 8-15, 8-16, 8-30, 8-83

E

Embargo...................................................... 8-14, 8-15, 8-16

F

Farm.......................................... 8-12, 8-27, 8-46, 8-47, 8-66

FATA..................................................................... 8-18, 8-21

I

Illness .........................8-5, 8-7, 8-8, 8-31, 8-33, 8-39, 8-40, 8-

41, 8-49, 8-52, 8-55, 8-59, 8-72

Infant Formula......................8-7, 8-8, 8-41, 8-44, 8-48, 8-65

Injury.................................... 8-5, 8-7, 8-8, 8-18, 8-19, 8-20, 8-

23, 8-24, 8-40, 8-41, 8-42, 8-43, 8-45, 8-48, 8-49, 8-50, 

8-51, 8-52, 8-53, 8-55, 8-56, 8-58, 8-59

Internet .......................................................8-25, 8-26, 8-42

Interview......................................8-19, 8-21, 8-22, 8-23, 8-29, 

8-32, 8-34, 8-35, 8-36, 8-38, 8-44, 8-47, 8-52, 8-55

M

Medical Records......................8-5, 8-23, 8-24, 8-25, 8-36, 8-

39, 8-42, 8-43, 8-44, 8-49, 8-52

O

OCI......................................8-4, 8-6, 8-14, 8-17, 8-18, 8-19, 8-

20, 8-21, 8-26, 8-48

Outbreak..................... ... 8-5, 8-24, 8-27, 8-31, 8-32, 8-33, 8-

34, 8-35, 8-36, 8-38, 8-39, 8-46, 8-47, 8-64, 8-69, 8-72

R

Reconditioning ............................................8-16, 8-17, 8-30

Relabeling...................................................................... 8-17

Report.......................................... .. 8-3, 8-4, 8-5, 8-6, 8-8, 8-9, 

8-11, 8-17, 8-18, 8-19, 8-20, 8-21, 8-23, 8-24, 8-27, 8-

28, 8-29, 8-30, 8-31, 8-32, 8-34, 8-39, 8-40, 8-41, 8-42, 

8-44, 8-47, 8-48, 8-49, 8-50, 8-51, 8-52, 8-54, 8-55, 8-

56, 8-57, 8-58, 8-59, 8-60

S

Sample............................ 8-3, 8-14, 8-16, 8-19, 8-20, 8-21, 8-

25, 8-26, 8-29, 8-30, 8-31, 8-33, 8-34, 8-36, 8-37, 8-38, 

8-39, 8-44, 8-45, 8-47, 8-48, 8-58, 8-60, 8-64, 8-68, 8-69

Surveillance ..........................................8-6, 8-50, 8-57, 8-59

T

Tamper...................... 8-4, 8-7, 8-8, 8-14, 8-17, 8-18, 8-19, 8-

20, 8-21, 8-23, 8-48, 8-50

Tobacco..............................................8-15, 8-27, 8-60, 8-80

W

Washout.................................................................8-6, 8-28