Contents

SUBCHAPTER 900 - INVESTIGATIONS

901 - INVESTIGATIONS GENERAL

This Chapter contains specific information on many types of investigations and each section provides additional guidance for you on how to investigate particular issues, special reporting requirements and where additional assistance can be obtained. Recall work, a special type of investigation, is covered in Chapter 8. There is an on-line training course in Investigations which covers many types of investigations and provides additional information.

An investigation is an information gathering activity you conduct for many different reasons. The purpose of any investigation is to determine and document facts concerning a particular issue so the Agency can make informed and sound decisions. Investigation is a general term and can apply to a very general activity or a specific type of information gathering process. Some specific types of investigations include a complaint investigation, a disaster investigation, a health fraud investigation and a product tampering investigation. Investigations can be distinguished from inspections because usually you will not need to issue an FDA 482, you will be working somewhere other than a manufacturing plant, you may be visiting retail establishments, consumers, or other government agencies. On rare occasions, you may be conducting an investigation without advising individuals you are a FDA employee. Keep in mind that investigations can not all be categorized and there will be times when you do issue an FDA 482, such as when you are at a manufacturing site or doing work similar to an inspection. Experience gained on the job will help you determine the proper course of action for these special situations.

Reporting an investigation is almost always done using a memorandum. The format is not as defined in sections as an inspection report. A good rule of thumb to follow is to first summarize what you did, why or give the reason for the investigation 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 many situations. For long narratives, using headings will make it easier for the reader to follow your reporting. Some types of investigations have forms that need to be completed in addition to the narrative. Your report will be in English, see IOM 100.

SUBCHAPTER 902 - Complaints

902 - COMPLAINTS - GENERAL

A complaint is notification that a product in commercial distribution may be in violation of the laws and regulations administered by FDA.

Complaints are received from various sources, including consumers, other government agencies, Congress on behalf of their constituents, trade associations, etc. Complaints should be promptly acknowledged in written format, by telephone or visit. See Field Management Directive FMD-119.

Consumers contacting field offices with complaints of injury or illness should receive a prompt, courteous response and assurance their complaints will receive appropriate consideration. An immediate follow-up may be warranted when there is an indication of a serious illness or injury.

Obtain sufficient information to enable evaluation of the complaint, determination of appropriate follow-up, and, if possible, enough facts to permit further FDA evaluation and response without subsequent contact with the complainant. If a complaint cannot be resolved immediately, determine if the complainant expects further contact. If so, report the best time to reach the complainant. For complaints involving special nutritional products, i.e., infant formula, medical foods and dietary supplements, complete the FACTS Adverse Event Questionnaire, See Exhibit 900-D. See IOM 925.02 for additional instructions regarding special nutritional complaints.

The FDA Office of Crisis Management /Emergency Operations Center ( OCM /EOC) HFA-615, (301) 443-1240 must be notified immediately of all significant injury, illness and suspected tampering complaints. OCM/EOC must also be notified of all complaints regarding infant formula/baby food.

Significant injury/illness includes, but is not limited to, any life threatening event; seizures; severe respiratory distress syndrome including broncho-constriction or bronchospasm; acute asthmatic attacks, anaphylactic or hypotensive episodes; unconsciousness or coma, or any event requiring medical treatment. Also to be included are behavioral or mood disorders of sufficient intensity to alter the daily activities of the consumer. These complaints require immediate and thorough follow-up, unless specifically directed otherwise by OCM/EOC. OCM/EOC is also to be kept advised of the status of all such follow-up investigations. Information about complaints nationwide is available in FACTS and from OCM/EOC and may be helpful in determining appropriate follow-up.

Complaints concerning products which do not present a hazard to health may be investigated by the home district during the next planned inspection of the responsible firm.

If the complaint concerns a matter not under FDA jurisdiction, or one which would more properly be handled by another agency, refer the complainant to the appropriate organization whenever possible.

902.01 - Complaint Categories

Complaints can be divided into two categories:

Injury/Illness Complaints - A complaint indicating a serious injury, illness, hospitalization, or death requires immediate reaction. It will, in all likelihood, require immediate investigation, including the accumulation of epidemiological data and prompt liaison with other appropriate federal, state and local agencies.

A complaint that clearly indicates an illness resulting from consuming a FDA regulated product, and manifested by symptoms such as nausea, fever, or diarrhea, should receive prompt follow-up by FDA or cooperating officials.

Conversely, some illnesses are considered psychological in nature, e.g., a consumer finds a foreign object in a product and becomes ill because it is revolting. For purposes of conducting follow-up and reporting to headquarters, these should be handled as non-injury/illness complaints and do not need to be reported to the OCM/EOC.

Non-Injury/Illness Complaints - These do not require immediate follow-up at the consumer level. Follow-up may include examining the parent lot, referral to another FDA district, 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 OCM/EOC unless product tampering is suspected or the product is a baby food or infant formula.

902.02 - Infant Formula and Baby Food

There is a continued sensitivity to all reported incidents involving infant formula or baby food. All complaints involving either infant formula or baby food are to be thoroughly investigated on a high-priority basis. This will include follow-up at the doctor or hospital (if an injury/illness is involved), with the collection and analysis of appropriate samples. Complaints involving baby food that is regulated by USDA should be referred to USDA for appropriate follow-up. See IOM 910.03 and 311.02.

There are two exceptions for collecting samples as part of the follow-up to infant formula/baby food complaints:

1. Complaints involving outdated product in the marketplace, with no associated injury or illness. These do require investigation to assure all outdated product has been removed from the identified retail and/or wholesale source.
2. Complaints involving an illness associated with normal appearing product, but follow-up investigation discloses a physician's diagnosis that the event does not appear to be product related, or that the event was an allergic response to a properly labeled product.

Also see the following:

1. IOM 925.02 - Dietary Supplements
2. IOM 910 - Foodborne Outbreaks

902.04 - Complaints Involving Alcoholic Beverages

OCM

902.05 - Emergency Operations Center Guidance

The FDA Office of Crisis Management/Emergency Operations Center (OCM/EOC) HFA-615, (301) 443-1240 must be notified immediately of all serious injury/illness and tampering complaints. The OCM/EOC is also to be kept advised of the status of all such follow-up investigations. Information about complaints nationwide is available in FACTS and from the OCM/EOC and may be helpful in determining appropriate follow-up.

As unique situations arise, EOC provides guidance concerning the type of follow-up to be made. This guidance should be kept on file by the district consumer complaint coordinator.

902.06 - Interviews

The key to thorough consumer complaint investigation is complete interviews with the complainant and/or others knowledgeable about the incident (other family members, health professionals, law enforcement officials, etc.). In addition, in preparation for any consumer complaint interviews, you should take your personal safety into consideration. Refer to IOM 510.01 for more information .

The basic information to be obtained is in the FACTS Consumer Complaint Report which replaces the 2516 and the Consumer Complaint Follow-Up Report which replaces the 2516a. See IOM Exhibit 900-A and 900-B. It is important to accurately determine the sequence of events leading up to the complaint. This includes a 72-hour food history (for food related illness); whether the complainant used the product before (cosmetic or drug products); condition of the product when purchased or consumed (tampering complaints, mold in foods, possible mishandling, product abuse in the home, etc.); and storage of the products (if filth is the subject of the complaint).

There are additional considerations with injury/illness complaints. The prior medical history of the complainant may provide indications regarding allergies, drug side effects or drug-food/drug-drug interactions which may be responsible for the illness or injury. Medical verification should be sought in these situations. Food illnesses are frequently associated with the most recent food consumed, food that didn't appear or smell right, or a food consumed only by the ill person. Additional interviews may be required to identify other suspect foods, especially if the food implicated is not a likely vehicle for illness. Familiarity with items previously associated with illness or injuries is helpful in pursuing the investigation; such as pet turtles or occupational sources for Salmonella; incompatibility of soft contact lenses with lens solution or other eye products not specifically approved for use with them; production of acetic acid by aspirin as it decomposes; and the bitter or burning taste of calcium chloride-contaminated frozen ice cream novelties. Consider that individuals differ in sensitivity to bacterial levels or toxins, and not everyone using or consuming a contaminated product will show symptoms.

Additional information to be obtained for adverse events involving foods, dietary supplements, botanicals and cosmetics is contained in the FACTS Adverse Event Questionnaire and the Cosmetic Questionnaire, IOM Exhibits 900-D and 900-E.

The complainant may request a copy of your investigative report or sample results. Inform the complainant that they can receive the results of any sample collected from them, in accordance with the Freedom of Information Act (FOIA), after the Agency has determined that there is no consideration of criminal prosecution or such consideration has occurred and the matter is closed. Also inform them there may be a slight charge for the investigatory report as required by the FOI Regulations. See IOM 134.

902.07 - Medical Records

In investigating complaints where a health professional was seen by the complainant, 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 as a potential cause of the illness or injury to the health professional. 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 527.06.

If collection of medical records is necessary, use the FDA 461, Authorization for Medical Records Disclosure, signed by the patient or someone authorized to act for the patient. See IOM Exhibit 900-C. The FDA 461 is not required to obtain records from the Department of Defense (DOD) medical facilities. Identify yourself to the Commanding Officer of the facility or representative and request authorization to examine and copy records. DOD Directive 6040.2, Release of Information from Medical Records, authorizes release of medical information to government agencies.

NOTE: Many states require statements concerning other subjects besides those covered on the FDA 461. If the hospital does not accept the FDA version of the Authorization for Medical Records Disclosure, obtain and complete one of their forms for use at their facility.

Collect all medical records pertinent to the investigation.

902.08 - Sample Collection

Sample collection authority, definitions and procedures are discussed in detail in IOM Chapter 4.

A thorough investigation will provide information to form a hypothesis as to the cause of the illness or injury and will assist in determining what sample(s) to collect. Adequate samples should be collected immediately, while they are available. Do not overlook sampling any product which may be remotely implicated in the incident. Consult with your servicing laboratory for guidance on specific sample sizes. See IOM 925.02 for guidance on sampling dietary supplements.

In addition to the consumer portion, intact containers of products of the same lot should be collected from the retail and wholesale levels. These samples provide more useful information regarding the product in consumer channels, and may prove useful in any future legal action. Refer to IOM 425.01 for information concerning collection of consumer portions.

902.09 - Recording Complaints/Follow-ups