Inspections, Compliance, Enforcement, and Criminal Investigations

SUBCHAPTER 8.2 - COMPLAINTS

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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. Enter complaints into the FACTS Consumer Complaint System. 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. Unless a visit to the complainant is assigned, any and all information should be obtained during a telephone call with the consumer. Do not rely on the consumer to freely offer all pertinent information. Use critical thinking skills and ask pertinent questions to aid in identifying the problem and where it may have occurred. Record infor­mation on the consumer complaint form in FACTS.

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 8-1). See IOM 8.4.5.2.2 for additional instructions regarding special nutritional complaints.

The FDA Office of Crisis Management/Office of Emer­gency Operations (OCM/OEO) HFA-615, 301-796-8240 must be notified immediately of all significant injury, illness and suspected tampering complaints. OCM/OEO 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/OEO. OCM/OEO 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/OEO 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.

 8.2.1 - COMPLAINT CATEGORIES

Complaints can be divided into two categories.

 8.2.1.1 - Injury/Illness Complaints

A complaint indicating a serious injury, illness, hospitalization, or death requires immediate reaction. It will, in all likelihood, require immediate investigation. It may include 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, vomiting, 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/OEO.

 8.2.1.2 - 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/OEO unless product tampering is suspected or the product is a baby food or infant formula.

 8.2.2 - 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 8.3.1.3 and IOM 3.2.1.2.

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 ensure 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 8.4.5.2- Dietary Supplements
  2. IOM 8.3.1- Foodborne Outbreaks

 8.2.3 - COMPLAINTS INVOLVING ALCOHOLIC BEVERAGES

All tampering complaints involving alcoholic beverages should be entered as a consumer complaint in FACTS. OCM/OEO and OCI should be notified immediately. For all other complaints involving alcoholic beverages, please see IOM 3.2.8.1 for guidance.

 8.2.4 - OFFICE OF EMERGENCY OPERATIONS GUIDANCE

The FDA Office of Crisis Management/Office of Emergency Operations (OCM/OEO) HFA-615, 301-796-8240 must be notified immediately of all serious injury/illness and suspected tampering complaints. The OCM/OEO 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/OEO and may be helpful in determining appropriate follow-up.

There may be an occasion where OCM/OEO formally requests the district to forward a copy of a patient’s medical records to the appropriate Center for review by a medical officer. In order to protect patient privacy information, the medical records should only be forwarded to the appropriate medical officer. The OEO Emergency Coordinator assigned to the investigation/incident will provide the contact information (name of the medical officer, Center, address, and telephone number). On the day the package has been mailed or shipped to the Center medical officer, an email should be sent to the OEO emergency coordinator for documentation purposes.

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

 8.2.5 - INTERVIEWS

The key to a 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 5.2.1.2 for more information.

 8.2.5.1 - Basic Information to Obtain

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 Exhibits 8-2 and 8-3. 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. Enter this description in the Brand Name and Product Name sections of the FACTS complaint form.

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 has 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).

 8.2.5.2 - Injury/Illness Complaints

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.

 8.2.5.3 - Additional Information to Obtain

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 8-1 and 8-4. This information should be entered into FACTS by the District receiving the complaint prior to forwarding the complaint to the home district of the manufacturer.

 8.2.5.4 - Complainant Access to Report/Results

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 1.4.4.

 8.2.6 - 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 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 5.3.8.6.

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 8-5. It may be necessary to use multiple forms if medical records are at different locations. Have at least three FDA 461 forms available for patient signature. If you encounter 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.

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. 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 that a FDA 461 be submitted, use this form to obtain the records.Highlighted to denote updated text 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.
See IOM 5.10.5

 8.2.7 - SAMPLE COLLECTION

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

Prior to initiating sampling collection, you may consider contacting the home district of the manufacturing plant. They may be aware of an existing issue related to the product and problem.

A thorough investigation will provide information to form a hypothesis as to the cause of the illness, injury, or product problem 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 8.4.5.2 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 4.3.5.1 for information concerning collection of consumer portions.

 8.2.8 - RECORDING COMPLAINTS/FOLLOW-UPS

The FACTS Consumer Complaint Report and Follow-Up Report are used for recording and investigating all complaints (except drug reactions - see IOM 8.4.2.1), unless previously reported through one of FDA's other post-marketing surveillance systems. See IOM Exhibits 8-2 and 8-3.

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Page Last Updated: 12/18/2014
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