Inspections, Compliance, Enforcement, and Criminal Investigations

SUBCHAPTER 8.4 - INVESTIGATION - INJURY & ADVERSE REACTION

Table of contents

 8.4.1 - INVESTIGATIONS

The purpose for investigating injury and adverse reactions to drugs, devices, biologics, foods, dietary supplements, tobacco products, and cosmetics is to determine the cause of, and to prevent additional injury or adverse reaction to the consuming public.

Injury and adverse reaction complainants 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 investigating injuries or adverse reactions, do not make comments or enter into 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. Divulging infor­mation before the reports are confirmed or denied is inap­propriate, and not to be done.

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.

Personnel routinely receiving complaints should be par­ticularly sensitive to those involving recently approved drugs, devices and biologics. Clinical trials may not have identified all possible adverse reactions, and FDA's ap­proving Center may want to reconsider current labeling, modify directions for use, establish registries for monitor­ing distribution, or withdraw approval based on the most recent information.

 8.4.1.1 - Procedures

When investigating all injuries and adverse reactions:

  1. Complete a FACTS Consumer Complaint Report and FACTS Follow-up Report (replaces the FDA 2516 and 2516a) to record and investigate all complaints, unless previously reported through one of FDA's other post marketing surveillance systems such as MedWatch. For special nutritionals, complete the FACTS Adverse Event Questionnaire. For cosmetics, complete the Cosmetics Adverse Event Report. See IOM Exhibits 8-1, 8-2, 8-3, 8-4.
  2. Provide complete details on the product involved, including brand name and identity statement with all qualifiers appearing on the label and code marks. In device cases, obtain a wiring diagram or furnish a complete description. Take photographs, if appropriate.
  3. Identify the source of the offending article.
  4. Provide details of how the product was used, including frequency, in what amounts, other on-going treatments, any known previous adverse reactions or pre-existing allergies and whether applied by the user or someone else. Determine if label directions were followed. Obtain copies of all labeling/inserts. Also, be alert for medical research or literary reviews the reporting party may have conducted or relied upon, and collect copies of such research or reviews. The device community has various publications of frequency of types of adverse events investigated and findings.
  5. Obtain a 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.
    1. Include any hospital or physician's records available, and identify pre-existing conditions which may have a bearing on the injury or adverse reaction.
    2. Obtain photographs of the victim's injuries, if significant. See IOM 8.2.6 for the procedures used to obtain medical records.
  6. 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.
  7. Ask the consumer if an attempt to report the adverse reaction to the product manufacturer has been made, and the nature of the manufacturer's response, if known.
  8. Any other consumer complaints, injuries or alleged adverse reactions reported to the manufacturer concerning the product.
  9. If necessary, obtain distribution information of the implicated lot(s) from the manufacturer.

 8.4.2 - DRUGS - INJURY OR REACTIONS

Drug injuries or reactions, either human or veterinary, result from the use of products which may:

  1. Vary markedly from declared potency.
  2. Contain deleterious substances.
  3. Be mislabeled as to identity, warnings, or instructions.
  4. Have been mistaken for other drugs despite proper labeling.
  5. Have changed composition, or become contaminated after shipment.
  6. Be dangerous when used according to directions.
  7. Have not been used in accordance with label directions or directions from the prescriber.
  8. Have been improperly administered, or administered without the necessary precautions.
  9. Have been contaminated with objectionable microorganisms, soaps or cleaning solutions.
  10. Have been misidentified.
  11. Be labeled as sterile drugs, but are found to be non-sterile.
  12. Have adverse effects that were not identified prior to marketing.

 8.4.2.1 - Investigative Procedures

The following procedures should be followed for investigating suspected adverse drug reactions, including drug-induced birth defects:

  1. 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 8-5).  Reporting of drug adverse experiences is voluntary and you should encourage and assist complainants and health care providers to complete the  FDA 3500 form (see Exhibit 8-10) and submit to MedWatch.  Report your findings in FACTS Consumer Complaint Follow-up screens and in a memo of investigation.
  2. If you are investigating an adverse reaction at the manufacturer, conduct your investigation in an attempt to determine whether the adverse event was caused by a drug quality defect.  Determine if the manufacturer was aware of the complaint, has conducted an investigation and per IOM 5.5.7 Adverse Event Reporting has submitted the reportable event to FDA.  Your findings will be reported through FACTS Consumer Complaint Follow-up screens and a memo of investigation or Establishment Inspection Report.
  3. You may also be directed to conduct investigations at other establishments, such as pharmaciesEnd Changed Text 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.

 8.4.3 - DEVICES - INJURY

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.

 8.4.3.1 - Mechanical, Electrical or Electromechanical Devices

Injuries caused by mechanical, electrical or electromechanical devices may result from devices that:

  1. Do not conform to specifications due to:
    1. Mistreatment (e.g., damage in transit), or
    2. Failure to comply with good manufacturing practices.
  2. Malfunction because:
    1. Of incorrect installation,
    2. Have not been used in accordance with labeled instructions,
    3. Have been used/installed with accessories or parts which are not compatible,
    4. Have been used under conditions which interfere with their ability to function (e.g., electromagnetic interference (EMI), fluid seepage into electrical circuits, etc.),
    5. Have been damaged during use, or
    6. Random failures.
  3. Have not been adequately designed for intended use (e.g., unstable, poor structural integrity, sharp or pointed surfaces, electrical leakage, etc.).
  4. Do not contain adequate directions or warnings.
  5. Are intended to be sterile but are non-sterile.
  6. Fail or deteriorate for any reason.

 8.4.3.2 - Devices for Implant

Causes of injuries which may result from implanted devices include those listed in IOM 8.4.3.1. The term installation, as used above, does not include implantation. Injuries also may result because the materials used in the implant are not biocompatible, thereby causing an adverse tissue reaction and/or deterioration of the implant.

 8.4.3.3 - In Vitro Diagnostic Devices

Certain In Vitro Diagnostics (IVD) are instruments, such as gas chromatographs and automated blood analyzers, and much of the information under IOM 8.4.3.1 is applicable.

Injuries to patients from IVD products may, in many cases, 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:

  1. Process errors and mix-ups (e.g., varying fill in kit components, improper ingredient addition, etc.).
  2. Labeling does not contain adequate directions or warnings, or contains incorrect information.
  3. Labeling mix-ups.
  4. Contamination, making the product unusable or causing misdiagnosis.

User errors include:

  1. Failure to follow label directions
  2. Use of unclean or poorly calibrated laboratory equipment.
  3. Improper storage of reagents

 8.4.3.4 - Investigative Procedures

When investigating incidents implicating a medical device, you must first confirm whether or not the device was a contributing factor. An appropriate follow-up, such as inspection at the manufacturer, may be necessary.

Current agency policy defers regulation to the Department of Transportation (DOT) of automotive adaptive equipment which are medical devices. Consumer complaints or other reports concerning these devices should be referred to DOT.

Copies of EIRs, FACTS Consumer Complaint Report and Follow-Up Report, including documentation and related materials, for all device consumer complaints should be sent to HFZ-343.

Reports received through the Medical Device Reporting system are not considered to be consumer complaints and are tracked through a system maintained by CDRH. A FACTS Consumer Complaint Report should not be completed for any incident that CDRH has requested follow-up on via MDR, unless you originally were advised of the incident by a consumer and initiated a FACTS Consumer Complaint Report at that time. For additional information concerning MDR reports, see the applicable Compliance Program in the CPGM.

Interview the victim, physician(s), and any other individual(s) who witnessed or has knowledge of the incident. When conducting an investigation at a hospital, be sure to contact and inform the administrator of the purpose of the investigation.

 8.4.3.4.1 - DEVICES

Obtain the following information for devices:

  1. A complete description of the incident (sequence of events) and the injury, including:
    1. Type, model, serial number and manufacturer of the device.
    2. Details of the alleged incident, including: number of people involved; symptoms, onset time and 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; 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 8-5, 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 bio-engineering department personnel may be indicated.
  6. Who has access to the device, and 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.

 8.4.3.4.2 - IN VITRO DIAGNOSTICS

For In Vitro Diagnostics, determine:

  1. What are the results of the test used for? (Screening, therapeutic drug monitoring, epidemiological information, monitoring the course of disease, susceptibility testing, etc.)
  2. The clinical value or worth of the test (is it diagnostic, does it only aid in diagnosis).

The report of the investigation and related documentation is extremely important and must be promptly submitted. The report will be used by CDRH Medical and Scientific Review Staff in their health hazard evaluation.

 8.4.3.4.3 - DIALYSIS INJURY OR DEATHS

For Dialysis Injury or Deaths, in addition to the general device investigative procedures,

  1. Obtain the following information:
    1. Determine time of incident (i.e., at beginning of procedure, or after several hours of operation).
    2. Actions taken by staff, the number of patients normally treated, medications given, etc.
    3. Whether reuse of the dialyzer is practiced (manual or automated).
    4. Contact and interview maintenance personnel, where appropriate. Verify there is a maintenance schedule.
    5. Verify whether checks on alarm systems were performed prior to each start up and at any other critical stages in the operation, and how often. Determine the last time temperature and/or other alarm systems were calibrated.
  2. Verify when the dialysis facility filed a User Facility Report (UFR) in compliance with the Safe Medical Devices Act of 1990.
  3. Describe the type of water treatment devices used to make the dialysate. Verify who services and maintains the water treatment system, including off-site regeneration systems. Determine when these services were performed and recorded (name and times), in relationship to the incident. Report, for off-site regeneration systems, whether the resin bed regeneration was "medical use only" or mixed with other uses.
  4. Where a dialysis center practices reuse of dialyzers, determine the type of disinfectant method used (manual or automated), type of disinfectant used (i.e., formaldehyde, renalin, glutaraldehyde, etc.) and review the service and maintenance records for proper procedure including names, dates and time.

 8.4.4 - BIOLOGICS - INJURY, REACTION OR FATALITY

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:

  1. Vary from declared potency.
  2. Have been contaminated during manufacturing, shipment, or after shipment.
  3. Be mislabeled.
  4. Not have been given according to directions.
  5. Not have been stored under proper conditions.
  6. Have been provided to the wrong person.
  7. Contain substances innocuous to most people, but which the recipient is unable to tolerate (anti-Kidd, anti-Duffy), or contains substances not usually present in such a product which stimulate an adverse response in the recipient (HLA antibodies).

 8.4.4.1 - 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.

The Vaccine Adverse Event Reporting System (VAERS) is administered under a joint FDA/CDC contract. The system utilizes a preaddressed and postage paid form (Form VAERS-1) for reporting adverse events which occur subsequent to vaccine administration. See IOM Exhibit 8-11.

 8.4.4.2 - Investigation/Reporting

When a biologics reaction/injury complaint is received by the district office (DO), a preliminary investigation should be conducted. CBER should be consulted before initiating any follow-up which extends beyond the complainant, and in some cases even before the complainant interview.

All complaints initially received by the District Office must be recorded on the FACTS Consumer Complaint Report. When interviewing the complainant about a biologics complaint/injury, obtain:

  1. Complete description of the complaint/injury.
  2. Onset and duration of the reaction/injury.
  3. Name of product administered, include date and time of administration.
  4. Manufacturer and lot number of product, 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 Center and the OCM/OEO contact. Immediately, CBER offices will advise whether reactions are expected or unexpected, and the level of investigation, including sample collection and analysis, necessary. Further follow-up is unnecessary until it has been determined the reaction/injury is not unexpected, or has not already been reported through other channels.

Vaccine Products - If the complaint involves an adverse reaction of any kind, then a Form VAERS-1 (IOM Exhibit 8-11) should be sent to the complainant. The form should be completed by the complainant's physician, if at all possible, or by the complainant, if the physician will not cooperate. The completed VAERS Reporting Form should be mailed directly 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.

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.

Biological Products - If the complaint is an adverse reaction to a product, an FDA 3500, MedWatch Form (See IOM Exhibit 8-10) 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.

If the complaint does not involve an adverse reaction, obtain information necessary to permit the Center or home district to 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 the complaint is a fatality where blood or a blood component is implicated, notify CBER, Office of Compliance and Biologics Quality, as soon as possible (21 CFR 606.170). This is required of the collecting facility, in the event of a donor reaction, and by the facility which performed the compatibility tests, in the event of a transfusion reaction. An investigation of the incident shall be conducted by either HCFA or FDA, based on the type of facility involved, for example, transfusion service, blood bank, plasma center or hospital.

 8.4.5 - FOODS, DIETARY SUPPLEMENTS AND COSMETICS - INJURY OR REACTION

CFSAN regulates a wide variety of products including foods, seafood, wine beverages less than 7% alcohol (in­cluding wine coolers), bottled water, food additives, infant formulas, dietary supplements, and cosmetics. Each of these products is used differently and regulated under a different part of the Act and thus has slightly different in­vestigational requirements. Background and common causes for adverse events are provided for selected prod­ucts below.

Monitoring of complaints on CFSAN products is performed by the CAERS Staff. CFSAN investigations are generally limited to serious adverse events. Therefore, for serious adverse events (previously defined above in IOM 8.2.1.1) follow the specific investigation requirements below, in addition to the general investigation requirements above.

NOTE: Contact the CFSAN Adverse Events Reporting System (CAERS) Staff, HFS-845, 240-402-2405, Fax: 301-436-2452, or email CAERS@fda.hhs.gov, for all questions pertaining to field follow-up requests or medical guidance on investigations of adverse reac­tions associated with CFSAN monitored products. CAERS will coordinate with the office experts.

 8.4.5.1 - Cosmetics

It is important that FDA conducts appropriate investiga­tions and follow-up on adverse events attributed to cos­metic products.

Confusion regarding a product’s legal status as a cos­metic, a drug or a combination drug/cosmetic may impede investigational use of complaint system information. 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 http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074201.htm.  Questions may also be directed to the Office of Cosmetics and Colors at (240) 402-1130.
Injuries or adverse reactions may arise from cosmetics which:

  1. Are inherently dangerous or which may prove harmful or injurious to a consumer;
  2. 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;
  3. Have undergone formulation changes, or been chemi­cally or microbiologically contaminated while in the pos­session of the manufacturer, dealer, distributor, or end user;
  4. 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;
  5. Have been misused.

 8.4.5.2 - Dietary Supplements

The Dietary Supplement Health and Education Act of 1994 (See DSHEA) defined the term "dietary supplement" to mean a product taken by mouth that contains one or more dietary ingredients (i.e., vitamins, minerals, herbs or other botanicals, amino acids, and dietary substances, as well as a concentrate, metabolite, constituent, extract, or combination of any of the dietary ingredients). The intended use of a dietary supplement is to increase the total dietary substance or to supplement the diet. Under DSHEA, a dietary supplement is a food which must be labeled as a "dietary supplement" and cannot be represented for use as a conventional food or the sole item of a meal or diet.

DSHEA also removes dietary ingredients from coverage under the food additive provisions of the FD&C Act. Rather, DSHEA places the burden on the Agency to prove a dietary supplement or dietary ingredient is adulterated before the product can be removed from the marketplace.

Therefore, a crucial source of information on potentially unsafe products is the Agency's consumer complaint system. It is extremely important that FDA conduct appropriate investigations and follow-up on adverse events attributed to dietary supplement products.

The instruction and guidance provided in IOM 8.4.5.2.1/2 must be followed when conducting follow-up on complaints involving adverse reactions to special nutritional products.

 8.4.5.2.1 - CAUSES

Injuries or other adverse reactions may be associated with the use of products which:

  1. Vary markedly from the declared potency or concentration.
  2. Contain deleterious substances accidentally included in their manufacture.
  3. Have changed composition or become contaminated after shipment.
  4. Are mislabeled as to identity, warnings or instructions for use.
  5. Have not been used according to label instructions or the directions of the manufacturer or prescriber.
  6. Are dangerous when used according to directions.

 8.4.5.2.2 - PROCEDURES

When investigating adverse events attributed to special nutritional products, direct attention to, and document:

  1. Complete details on the product involved, including code marks.
  2. The source of the offending article.
  3. Details of how the product was used, including fre­quency, in what amounts, concomitant treatments, and whether administered by the user or someone else. Determine if label directions were followed. Obtain copies of all labeling/inserts.
  4. 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 8.2.6 for the procedures used to obtain medical re­cords.
  5. Names of other persons involved, such as medical per­sonnel, lawyers, insurance agents, etc. Obtain their views on the injury. The views of attending physician are important because they may vary markedly from those of the patient.
  6. A complete description of the incident (sequence of events) and the injury.

Complete the FACTS Adverse Event Questionnaire (See IOM Exhibit 8-1) either during the initial consumer contact (e.g., telephone report of complaint), or soon thereafter. The Adverse Event Questionnaire contains additional informa­tion which must be obtained and forwarded to CFSAN. Information already contained in the FACTS Consumer Complaint Report need not be duplicated on the question­naire.

NOTE: Contact the CFSAN Adverse Events Reporting System (CAERS) Staff, HFS-845, 240-402-2405, Fax: 301-436-2452, or email CAERS@fda.hhs.gov, for ques­tions pertaining to field follow-up requests related to foods, seafood, food additives, dietary supplements, infant formulas and medical foods. CAERS personnel will coordinate field guidance related to these prod­ucts with CFSAN's experts.

Questions on compliance or other regulatory matters should be directed to the Office of Compliance, Division of Enforcement, HFS-605, 240-402-2417.

 8.4.5.3 - 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 (IOM Exhibit 8-4).

If the suspect product is not a Cosmetic, interview the in­jured person and/or the reporter of the event and complete the Adverse Event Questionnaire (IOM Exhibit 8-1).

If suspect product is an Infant Formula or Baby Food, immediately in­form OCM/OEO at 301-796-8240 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 to USDA for appropriate follow-up. See IOM 8.3.1.3 and 3.2.1.2.

Obtain Medical Records Release forms (FDA-461) from the injured person or guardian.

If the adverse event is a death, the following medical re­cords should be considered for collection:

  1. Admission History and Physical or Emergency Room/Clinic record of the event if the patient was not admitted
  2. Discharge Summary
  3. Autopsy Report
  4. Death Certificate

Samples - If you believe a suspect product should be sampled, discuss with your Supervisor. See IOM 8.2.7 for guidance.

For all events, a memo of investigation will be completed. Send a complete copy, including copies of all labels and labeling, Medical Records Release (FDA 461) and medi­cal records collected to the CAERS Staff. 

 8.4.5.4 - Undeclared Allergen/Allergic Reactions

We often receive complaints involving allergic reactions to food products containing suspected undeclared allergens.  It is important to obtain specific information unique to these complaints.  Suspected undeclared allergen complaints should receive high priority.  Undeclared allergens in food products often result in recalls.

The following should be addressed with the consumer and recorded in the “Complaint Description” section of the FACTS consumer complaint report:

  1. List all foods the person is allergic to.
  2. List all foods consumed within approximately the hour prior to reaction.
  3. Indicate how much was consumed of the suspect food(s).
  4. Record the on-set time of the reaction.
  5. List all symptoms experienced in the order they occurred.
  6. Indicate treatment given.
  7. Record the ingredient statement from product packaging on the complaint form (“Remarks”-page 1).  (Look for hidden allergens within the ingredient statement.)
  8. Indicate if the label includes a “may contain” statement and record the statement.
  9. Indicate whether the consumer has a documented food allergy.  (It may be necessary to collect the medical records as the investigation of the complaint progresses.)

Inspectional follow up at the manufacturing plant may be warranted to determine if suspect allergenic ingredient is added to the product; or if the possibility of cross-contact exists.

The Food Allergen Labeling and Consumer Protection Act (FALCPA) became effective 1/1/2006.  See the FDA Website for additional background information related to it.

 8.4.6 - VETERINARY PRODUCTS - COMPLAINTS/ADVERSE REACTIONS

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 the Center for Veterinary Medicine. The District should advise the complainant to complete a 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 http://www.fda.gov/cvm/adetoc.htm.

For 3 day Field Alert Reports (FAR), the drug manufacturer should notify and submit the FAR to their respective District office within 3 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 the Center for Veterinary Medicine. Veterinarians, animal owners and firms may report pet food problems to consumer complaint coordinators at their FDA District Office or OCM/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 http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm182403.htm.

If you become aware of human illnesses associated with CVM regulated products, contact the appropriate Emergency Response Coordinator in your District and/or Regional Office immediately who will then contact the CORE Signals Team at CORESignalsTeam@fda.hhs.gov.Highlighted to denote updated text

 8.4.7 - SAMPLE COLLECTION

Collect a sample of the product which caused the injury and an official sample from the same lot. Collect the same and other lot codes, if available. Check with your supervisor if you have any doubt as to the appropriateness of collecting a particular sample.

See IOM 4.5.5.3 for routing of injury and complaint samples to the laboratory.

 8.4.7.1 - Device Samples

Obtain Center concurrence prior to collecting any device samples.

 8.4.7.2 - Biological Samples

Do not collect samples of the suspect product until an evaluation of the preliminary information on the injury/reaction has been made by CBER (Licensed products) or the Home District (Unlicensed Products, Plasma and Blood Products).

 8.4.7.3 - Cosmetic Samples

Products such as depilatories, 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.

 8.4.7.4 - Microbiological Contamination

Collect samples associated with consumer complaints in which microbiological contamination is suspected.

 8.4.7.5 - Allergen Samples

Sample if the allergen is visible (i.e., nuts) and is not declared on label (and if deemed necessary by District manage­ment). In all other cases, collect a sample only after consultation with 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.

8.4.7.6 - Tobacco Products Samples

When collecting tobacco product samples as a result of a product complaint or adverse report investigation, see IOM 4.5.5.3.8, for sample collection guidance and contact CTP’s Office of Compliance and Enforcement.

 8.4.8 - REPORTING

Prompt reporting is essential. You may save the lives of others with prompt reporting. See IOM 1.1 English language requirement.

 8.4.8.1 - Reporting Forms

Field personnel should report all consumer complaints in FACTS. In addition, for adverse reactions or injury associ­ated with drugs, medical devices, cosmetics, tobacco products, and biologics (except vaccines), provide complainants with the MedWatch web address (www.fda.gov/medwatch) or the FDA 3500 MedWatch form (IOM Exhibit 8-10). Prior to sending a MedWatch form to the complainant, enter the FDA FACTS consumer complaint number in the box below the Triage Unit Se­quence # in the upper right corner of form FDA 3500.

For complaints with veterinary products including animal drugs, medicated feeds, and medical devices for animals, provide complainants with an FDA 1932a "Veterinary Drug Adverse Experience, Lack of Effectiveness or Product Defect Report".

For adverse reactions to vaccine products, provide com­plainants with form VAERS-1 (IOM 8.4.4.2, IOM Exhibit 8-11). 

 8.4.8.2 - Routing Reports

A copy of the FACTS consumer complaint report and your narrative report(s), including any copies of medical or injury reports obtained should be submitted by your district to the appropriate office.  Fax transmission may be used.

 8.4.8.2.1 - 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

 8.4.8.2.2 - MEDICAL DEVICE AND RADIOLOGICAL PRODUCTS

Submit medical device and radiological product complaints and injuries to:

Food and Drug Administration
Center for Devices and Radiological Health
Division of Surveillance Systems (HFZ-530)
WO66 10903 New Hampshire Avenue
Silver Spring, MD 20993

 8.4.8.2.3 - FOODS AND COSMETICS

If the online MedWatch form is not used for reporting adverse events, send both adverse events and product problems for CFSAN regulated products including cosmetics, infant formulas, dietary supplements and all other foods to:

Food and Drug Administration
Center for Food Safety and Applied Nutrition
CAERS Staff (HFS-845)
Attn: CAERS Monitor
5100 Paint Branch Pkwy
College Park, MD 20740

 8.4.8.2.4 - 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

 8.4.8.2.5 - LICENSED BIOLOGICAL PRODUCTS

For licensed biological products (includes vaccines), ex­cept for source plasma and blood products, the receiving district will complete the FACTS consumer complaint re­port and fax a copy to HFM-650 at 301-827-6748, select HFM-650 in the referrals box and then electronically for­ward to the home district. The home district will select "Surveillance for Next EI" as the final disposition and close the complaint. CBER will issue an assignment if follow-up is needed.

 8.4.8.2.6 - UNLICENSED BIOLOGICAL PRODUCTS

For unlicensed biological product, plasma, blood and blood products, the receiving district will complete and electronically forward the FACTS consumer complaint to the home district and send a hard copy to HFM-650. The home district will determine if any follow-up is needed and issue an appropriate assignment. Advice is available from HFM-650 at 301-827-6220.

 8.4.8.2.7 - BIOLOGICS INJURY/ADVERSE REACTION REPORTS

Submit biologics injury and adverse reaction narrative reports to:

Food and Drug Administration
Center for Biologic Evaluation and Research
Office of Compliance
1401 Rockville Pike, Suite 400S
Rockville, MD 20852

NOTE: In addition, check the "Notify EO/EMOPS?" box in FACTS for all injury and adverse reaction complaints. For serious injury/illness reports, please notify the OCM/OEO immediately at 301-796-8240.

8.4.8.2.8 – TOBACCO PRODUCTS INJURY/ADVERSE REACTION REPORTS

If the online MedWatch form is not used for reporting adverse events, send the hardcopy MedWatch form to:

The FDA Safety Information and Adverse Event Reporting Program
Food & Drug Administration
5600 Fishers Lane
Rockville, MD 20852

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