PURPOSE

To provide ORA personnel with general guidance in defining and categorizing, evaluating and disposing, program monitoring and data reporting of consumer product complaints.

BACKGROUND

The Consumer Complaint system collects information on the condition of FDA regulated products on the market which consumers are dissatisfied with. This information can be compiled and evaluated to highlight current problems and long term trends. It can be used as background data in the development of Center programs.

The current revision reflects changes in the headquarters office phone numbers, sources of complaints, district responsibilities, complaint form distribution, and consumer education.

COMPLAINT DEFINITION

A consumer complaint is notification that a product in commercial distribution:

1. May be in violation of the laws or regulations administered by the FDA.
2. May have caused an illness, injury, or death.
3. Is alleged to have caused problems not covered by the above.

SOURCES OF COMPLAINTS

Complaints may be received from consumers, other government agencies, trade sources, or health care professionals. Complaints received through the following sources will not be duplicated by treating them as consumer complaints in the ORA Consumer Complaint System:

1. Adverse Veterinary Drug Reaction System (CVM)
2. Voluntary Cosmetic Product Experience Reports (21 CFR 730)
3. Vaccine Adverse Experience Reporting System
4. FDA Medical Products Reporting System (MEDWATCH)

MEDWATCH is for health professionals to report product problems and adverse events associated with drugs, biological products (other than vaccines), medical devices, dietary supplements, infant formulas, medical foods, and food additives.

Complaints received directly from consumers on these products should be reported in the ORA Consumer Complaint System. Appropriate forms shall be completed as directed in Chapter 9 of the IOM.

HEADQUARTERS RESPONSIBILITIES

ORA/ORO/DEEO Epidemiological Investigations Branch (EIB) (HFC-161) is responsible for the overall management of the Consumer Complaint System. EIB will serve as liaison between field coordinators, the Centers and ORA and will aid in the resolution of system problems encountered by district personnel. Questions and comments should be referred to HFC-161 at 301-443-1240 or 301-443-4667.

DISTRICT RESPONSIBILITIES

Each district office should assign the oversight of the Consumer Complaint System to management personnel (including Compliance Officers) within its staff. The responsibility may be permanently assigned to an individual or rotated among individuals, whichever is most efficient for the office.

The receiving office should establish a written Standard Operating Procedure (SOP) for the handling of complaints including such items as logging, distribution, filing, sample analysis, consumer notification of analytical results, and PODS coding. If appropriate, district subunits may need to prepare a coordinated SOP in concert with the district plan. A copy of the SOP and each amendment are to be provided to HFC-161 upon completion.

DEEO/EIB (HFC-161) should be advised of the name, position, and phone number of the district monitor.

Districts should maintain a log book containing the keys to manufacturers codes. The complaint coordinators should update keys to the codes of their district manufacturers. Copies of these updates should be forwarded to HFC-161 will provide copies to all of the districts.

CANADIAN PRODUCT COMPLAINTS

Consumer complaints involving products of Canadian origin should be investigated by FDA as indicated by their nature or seriousness and appropriate action taken. After investigation or evaluation, the complaint should be forwarded to EIB, HFC-161 for referral to Canadian authorities. Similarly, Canadian authorities will forward U.S. product complaints to HFC-161 for referral to FDA districts.

CATEGORIES OF CONSUMER COMPLAINT

The degree of response which the Food and Drug Administration will make in following up a consumer complaint will be based on the seriousness of the problem.

Complaints are divided into two categories:

1. Injury/Illness Associated Consumer Complaints

   These complaints concern injury or illness that is thought to have occurred as a direct result of using a product or a product defect that appears to have the potential to cause illness or injury if used.

   1. The FDA response to consumer complaints which are acutely life-threatening or cause serious adverse health consequences should be immediate. Most cases will require epidemiological data gathering and evaluation. Situations such as botulism alerts, extensive food poisoning outbreaks, life threatening drug reactions or device defects would fall into this category. The response may be either the immediate dispatching of an investigative team or assuring that some other public health/regulatory/investigative agency (CDC, State, Local, or Federal) is on the scene and liaison has been established.
   2. A prompt follow-up, normally within 1-2 days of receipt, should be initiated when the information received indicates a less serious illness or injury situation, real or potential, with rapid recovery. This complaint usually concerns the use or consumption of a product, or a portion thereof, with subsequent adverse physiological effect such as gastrointestinal symptoms, dermal or ocular injuries associated with cosmetics, and device failures. Suspect drug induced birth defect complaints will be followed up in this category. Adverse drug reactions known to be specific to a given drug will have limited follow-up under this category. These complaints are in contrast to those apparent psychological illnesses (e.g., a consumer finds a foreign object in a product and becomes ill because of its repulsiveness). Such psychosomatic illness complaints will be placed in category 2.

      NOTE: Any follow-up on cosmetic complaints must follow current program guidance. Infant formula complaints will be followed up in this category-except for outdated product which falls under category 2.

2. Non-Injury/Illness Consumer Complaints

   These complaints do not require immediate or prompt follow-up but may be investigated, referred, deferred to a pending EIR, or closed without further investigation at management's discretion (e.g., insects or foreign object in package or canned product, FPLA violations). See note above about infant formulas.

EVALUATION AND DISPOSITION

All consumer complaints must be evaluated and then resolved in one of the following ways:

1. Immediate Follow-up - This disposition will be used to cover category 1 follow-ups and where appropriate and indicated, category 2 follow-ups.
2. Follow-up next EI - This disposition covers category 2 complaints. It may be used for those instances where follow-up is either assigned for coverage at management's discretion per workload requirements, or assigned for coverage at the next inspection.
3. Closed Without Further Investigation - For category 1 and category 2 complaints, an explanation for this disposition must be provided in the remarks section.
4. Referred to Other Federal Agency.
5. Referred to State/Local Agency.
6. Referred to Other FDA District - Action to be taken on 1 and 2 above may be any of the following.
   1. Contact/visit complainant or source of product.
   2. Collect sample(s) - Complainant and/or other source.
   3. Inspect responsible firm.
   4. Combination of a., b., or c.

Category 1 and significant category 2 complaints should be investigated by the complainant's district to determine possibilities of compliance action against a parent lot and/or documentation of violative products through sample collection and analysis. Analysis of consumer complaint samples should be performed by the collecting district as spelled out in the RPM, or within the Region, and not sent to the home district for analysis. Exceptions may be made if the particular expertise is not available within the collecting district or region and/or prior arrangements with the home district or other laboratories are made. It is also the analyzing districts responsibility to advise the consumer of the results of the examination (See RPM, Chapter 7-50). Although the FDA 2516 and FDA 2516a should be forwarded to the home district only after complainant district investigation, notification of the home district about the problem will often be indicated prior to completion of investigation or sample analysis.

FORMS FDA 2516 AND 2516a DISTRIBUTION

Complete instructions for the distribution of copies of FDA 2516 and 2516a are found in IOM Exhibit 900 B.

A copy of all injury/illness complaints must be sent to EIB (HFC-161) and the appropriate headquarters Centers.

NOTE: The FDA 2516a is not to be distributed until after an evaluation and final disposition have been made.

CONSUMER COMPLAINT DATA REPORTING

All consumer complaints must be entered into the ORA Consumer Complaint System utilizing forms FDA 2516 and 2516a, as necessary.

Personnel time spent in following up complaints must be recorded into the complaint system and PODs by appropriate PAC and Product Codes. See PODs Manual for addition information. Special PAC codes for complaints or problems of sufficient significance to require specific tracking are issued as needed by Program evaluation Branch, HFC-42. The Program Assignment Code (PAC used on the original complaint is to be used to record all time expended on complaint follow-up activities that necessarily divert resources from planned Compliance Program coverage and which are the sole reasons for performing the operation.

DATA EVALUATION AND PROGRAM PLANNING

The Centers each have ability to use the data for program planning. HFC-161 does review the data on complaint by product on a national basis. HFC-161 can provide in formation on national data, upon request. Districts are able to obtain this information for their own district. Instructions for accessing the data by district offices are provided to the district DPUs.

CONSUMER EDUCATION

In line with the continuing Consumer Education programs, Public Affairs Specialists (PAS) should include information on how a consumer may complain to the Agency, in their presentations to groups and in materials distributed. The districts are encouraged to provide their PAS's with access to national and local complaint data for their possible use in programs. National data may be requested form HFC-161 obtained through the regional VAXs.