Inspections, Compliance, Enforcement, and Criminal Investigations
SUBCHAPTER 8.8 - COUNTERFEITING/TAMPERING
8.8 - COUNTERFEITING/TAMPERING
8.8.1 - REPORTING CONTACTS
126.96.36.199 - OCM / OEO RESPONSIBILITY
8.8.2 - COORDINATION WITH OTHER GOVERNMENT AGENCIES
8.8.3 - AUTHORITY & RESPONSIBILITY
8.8.4 - RELEASE OF INFORMATION
8.8.5 - INVESTIGATION
188.8.131.52 - General Procedures
184.108.40.206 - Interviews
220.127.116.11 - Sampling
18.104.22.168 - Complainants
22.214.171.124 - Retail Stores
126.96.36.199 - Manufacturer and Distribution System Follow-up
188.8.131.52.1 - MANUFACTURING SITES
184.108.40.206.2 - DISTRIBUTION FACILITIES
220.127.116.11.3 - SECURITY
8.8.6 - RECORD REQUESTS
8.8.7 - REFUSALS
8.8.8 - REPORTING
All reports of counterfeiting, tampering or tampering threats must be immediately reported to the Office of Criminal Investigations (OCI) Headquarters’ Office, SAIC-IOD (Special Agent in Charge- Investigative Operations Division) (301-276-9500) and the Office of Crisis Management (OCM)/Office of Emergency Operations (OEO), HFA-615, (301-796-8240).
If the complaint or report involves a USDA (United States Department of Agriculture) regulated product, the District office should report it directly to the USDA and notify OCI, SAIC-IOD and OCM/OEO immediately.
OCM/OEO is the focal point for communications; especially in those counterfeiting/tampering cases where regional/national coverage is necessary. Alert the OEO 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.
Federal - The Federal Bureau of Investigations (FBI) and the USDA share enforcement of the Federal Anti-Tampering Act (FATA) with FDA as described below:
- 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-IOD or the local OCI Field Office will coordinate all referrals to the FBI in accordance with agency policy.
- 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, SAIC-IOD and OCM/OEO immediately.
State and Local - 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 IOM 8.8.3. Assistance should be provided to cooperating officials as necessary or where requested.
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 8-14. 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 District Offices of their decision and the District Offices will determine the proper follow-up, which could include further investigation by the Districts or referral to local or state authorities. The District Offices 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 District management may also need to determine if a situational plan is warranted. Refer to IOM 18.104.22.168 – Personal Safety, and IOM 22.214.171.124 Situational Plan, for more information.
Information on matters under investigation by OCI should not be released without prior discussion and concurrence of the OCI Field Office.
Information regarding open regulatory investigations should not be released without prior discussion and concurrence of the OCM/OEO office.
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. Additional guidance on investigational authority under FATA can be found in IOM 8.8.3.
Counterfeiting/Tampering incidents historically have occurred in unpredictable forms and products. Standard operating procedures (SOPS), in most cases, will suffice for these investigations. As events take place, specific instructions for some investigations may be provided by OCI headquarters and/or your District 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 widespread?;
- Is it likely other, similarly affected FDA regulated products remain in distribution, and if so, what is the extent and magnitude of distribution?;
- If not isolated, could the product counterfeiting/tampering have occurred at the production facility or in the distribution chain?; and
- Can specific persons or points in the distribution chain be identified as possibly causing the problem?
When counterfeiting/tampering, threat or false reports are evident, or highly suspect, use the concepts listed below which are appropriate for the situation. Be sure to coordinate your efforts with OCI SAIC/IOD and OCM/OEO.
It is often advantageous to work in pairs during interviews with complainants. Conduct interviews in a location which reduces unnecessary interruptions or distractions. Establish rapport with the person or persons being interviewed to put them at ease. Listen to the person. Let them first tell the story in their own way. Listen carefully to each facet. Be genuine and at ease. After hearing the entire story, ask them for more information to fill in details. Ask for clarification of key points.
Obtaining details and requesting clarification of key points allows you to obtain an idea of the validity of the person's story through comparison of the accuracy of the details with previous information supplied.
Note-taking may put the person being interviewed on edge. If this appears to be the case, do not take notes until you request clarification of key points. For cases of counterfeiting/tampering, ask who was with the person, what happened in the store, any problems noted with the product at the store, and other questions which will provide you with more information on when, where, or why events took place, who was present, etc. If two investigators are involved in the interview, one should take notes while the other asks the questions.
During interviews, watch for changes in attitudes, body language, hesitation in speech, etc., as you observe and listen to the person being interviewed. Describe your observations of body language and personal characteristics in your report.
In most 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 by the wholesalers. OCI agents will at the same time conduct their investigation into the knowledge and source of the counterfeit products. It is NOT the purpose of the investigator to simply accompany the OCI agent during his/her investigation.
Tampering Cases: Follow these procedures:
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 6 intact units.
Collect any containers a suspect may have handled as they placed the tampered product on the shelf. Preparation of the sample and the shipping method should be carefully selected to insure the integrity and security of the samples. Coordinate with the OCI and the Forensic Chemistry Center (FCC) on correct sample packaging.
When handling product containers or other evidence associated with tampering, take care to avoid adding or smearing fingerprints by wearing cotton gloves, using tongs, forceps, or by picking the container up by opposing corners. Identify product containers carefully and in as small an area as possible. Do not open outer containers to identify inner containers or inserts.
When sampling or handling product, be alert for traces of evidence such as hair, dust, paint chips, glass fragments, etc. Secure such evidence in a separate container such as a glass vial, small manila envelope or plastic bag.
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 a spoon 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" (http://www.fbi.gov/about-us/lab/handbook-of-forensic-services-pdf) and was supplied to each district. As a precaution, rubber gloves may be worn inside of cotton gloves as protection against toxic or caustic substances.
Ship samples with extreme care to insure their integrity. Thoroughly describe your sample and its characteristics on the collection report (C/R) to facilitate the 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 and FDA-525. If speed is imperative consider hand delivery to the lab.
Counterfeiting Cases: Follow these procedures:
The District office may be asked to pick up suspect counterfeit products. Normal procedures for handling suspected products and the preservation of evidence should be followed as outlined in the tampering section for sampling above. In most counterfeiting cases, investigators do not usually collect an authentic sample of the same product. Authentic samples should only be collected when requested by OCI in consultation with FCC.
When visiting the complainant, use the standard consumer complaint procedures set forth in the IOM. Plan and think through the reasons for and goals for your visit before approaching the complainant. Listen carefully to the complainant. Review background of the complainant for history of complaints or lawsuits filed. Background checks are appropriate when district management has strong suspicions concerning the validity of the complaint or the potential for the complaint being used to defraud. It is often advantageous to work in pairs while interviewing complainants.
When collecting samples from the complainant, document them as official samples, including an affidavit describing the circumstances involved in the purchase and use of the product.
When investigating at a complainant's residence, obtain permission from the occupant to examine trash containers for discarded product labeling and/or containers which can be utilized to further investigations. Be alert to sources of contamination in the residence which are similar to the contaminants found in the product. Be sure to examine other containers of the same product in the residence with the owner's permission and sample them if suspect. Obtain permission to examine medicine cabinets if a drug dosage form is involved.
It is possible individuals you contact may not be aware of the provisions of the 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. Prior to concluding your interview of the complainant, obtain a signed affidavit attesting to the circumstances of the complaint, as directed by IOM 4.4.8. 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.
When investigating a counterfeiting/tampering report at a retail store or other source of product, the local police department can be of assistance and provide advice. Before instituting any activities at the scene, protect the area to preserve any evidence on the store shelves, floor or adjacent areas and products. Discuss with the firm's management, and/or the personnel doing the stocking of the shelves, how material is received and handled prior to being placed on shelves.
Document the area using photographs of the product shelves, surrounding area, and any shots which would provide information on the product, its location and store layout. Samples of materials in the area that may be applicable to the investigation are to be collected. Because suspects are thought to handle multiple product containers when placing a tampered product on a store shelf, a diagram of the container relationships to each other should be prepared and individual containers given subsample numbers.
Be observant of persons present in the store, as guilty parties are thought often to return to such location, especially when the agency or news media are present. Be alert to statements of store personnel about activities they have observed. Obtain descriptions of the actions, dress and physical characteristics of persons the employees have noted exhibiting unusual/notable behavior in the store. Ascertain if the firm has a closed circuit TV monitoring system and if they maintain tapes, if so, these may be a source of leads. Obtain information about employees terminated in past year, employee problems, or shoplifters who may wish to cause problems in the store.
The key to a successful investigation or inspection is to clearly define the objectives of the operation and to examine each facet of the establishment in light of the objective(s). Aspects of the production/distribution system to inspect for leads may include, but not be limited to the following:
Document the following:
- Age of facility, and date when production of the first batch of the product under investigation was initiated;
- List of other facilities which produce the product under investigation;
- For drugs, list by strength, size of container, name, dosage form, and number of packages per shipping case, all products manufactured or processed at the facility. If products handled are repackaged at this facility, give the name and address and method of receipt from the product source;
- Obtain the names, titles, addresses, office and residence telephone numbers of representatives of the company, including that of the Chief Executive Officer (CEO), who are specified as contacts for various aspects of the event under investigation. State whether these representatives are members of an established management team to deal with such events, or have they been identified for the particular instance at hand;
- Contract packagers, if any, should be described by name, location and products handled;
- For the suspect lot, document the lot number, the size of the lot, size and type of containers in which it was packaged, its history of production and distribution beginning with the date of weighing of the raw material, and the dates and description of steps in processing;
- Describe any locations within the facility where an employee could have access to the contaminant being investigated;
- Describe the characteristics of the suspected contaminant within the facility, its container type, its brand and generic name, its lot number, size of container, whether the container is full, or partially full and the approximate amount remaining;
- Describe security for the suspected contaminant including limitations of access, where it is stored, and responsibility for controlling access to the material.
- Describe what legitimate use, if any, the facility has for the suspected contaminant in each of the locations found;
- Determine how often the material is used and whether or not a log of its use is maintained;
- If a log is maintained, obtain a copy showing its use and discuss with plant management the legitimacy of each such use;
- Determine whether the firm verifies use and use rates and has a method of determining explanations for any discrepancies noted;
- Have samples of the suspect contaminant been obtained by the FDA or other agencies, and if so, what are the results of analysis?;
- Does the firm test for the contaminant under investigation?;
- What method is utilized for such testing, and at what frequency?;
- List the facility's sources of raw materials for the suspect lot/product;
- Evaluate the raw material storage conditions to determine the potential for manipulation of materials;
- Describe the lot numbering system, any plant identification numbers, and expiration dates placed on retail products and cases;
- If any product for export is processed at this plant, describe any differences from domestic products;
- If the product under investigation has tamper resistant packaging (TRP), determine the type of system utilized, and if the system utilized has been evaluated to determine if breaching is possible. If breaching is possible, describe. Describe lot numbers or code numbers placed on TRP and security measures taken for TRP materials on hand and those sent to contract packagers. Determine whether TRP materials are accountable;
- If the plant process includes collection of samples for examination on the production line or by laboratory facilities, discuss where the samples are maintained, who has access to them, and their disposition;
- Report dates and description of each step in processing, including identification of storage locations between steps. Obtain estimates of flow rates and volume of materials in hoppers and drums at key stages. Determine distances between production areas or between processing equipment at critical points. This information can be useful for statistical evaluation of the likelihood of contamination at various points in the process;
- Include a description of the in-process lot numbering systems for each phase of manufacturing, security for each process and/or product while in storage and during processing;
- In some types of processes, there are provisions for an individual to ensure sufficient product is placed in each container being filled. If this is the case in the plant under inspection, describe the circumstances and security for this process;
- Determine whether the facility hires part-time employees, or transfers employees from one location to another on a temporary basis. Were any were present during production of the suspect lot?;
- Describe provisions for determining reliability of employees;
- Determine if employees can move from area to area within the facility. Describe any restrictions on their movements and if enforced;
- Describe laboratory control tests and in-process tests performed on the finished packaged product and in-process materials. Determine if reserve samples are retained of all lots;
- Determine how rejects and reworked materials are handled;
- Describe any unusual events which may have taken place during the period when the suspect material was in the facility; and
- Determine if the firm has a plan to safeguard against counterfeiting/tampering as part of its quality assurance (Q.A.) program. If so, determine the implementation date of this plan and review any periodic assessment reports for potential problem areas.
It may be necessary to obtain the following information at each level in the distribution chain:
- Amount of suspect lot on hand at time of inspection;
- Obtain the turnover rate for the product under investigation;
- Amount of suspect lot received, and any variations from amount consigned to the facility;
- Date received;
- How received;
- Name and type of carrier which delivered the product. Determine security of the vehicle or container while in-transit;
- Obtain distribution history of the suspect lots;
- Describe the distribution area covered by the facility being inspected and the number of accounts served, whether they are retail or wholesale;
- Determine if the facility handles any cash and carry orders;
- Determine if the facility will accept returns and how are they handled;
- Describe stock rotation practices and how they can be assured;
- Determine if lot numbers of products distributed can be traced;
- Describe the method of packing of shipments; for example, plastic tote bins sealed with nylon tape, intact cartons only, cases are split, etc.;
- Describe the methods of shipment utilized by the warehouse; and/or
- Describe personnel practices, problems and other information on visitors, contractors, etc.
It is often advantageous to chart a pictograph or a time line chart of the distribution system which shows basic information on each level in the distribution chain and distances between each link in the chain. It is also often worthwhile to prepare a time-line chart showing the progression of the suspect lot through the manufacturing process to the source of the complaint, including the significant steps in the manufacture and distribution of the suspect product.
Obtain the following information. However, when preparing the EIR, do not report the details of the security system, since an inadvertent release could compromise a facilities security system. Discuss with your supervisor how to report this information.
- General security arrangements, including the number of guards, their shifts, locations, and whether or not they patrol the facility;
- Describe any closed circuit TV systems, their locations, and any physical barriers to prevent access to the plant grounds and its facility;
- Describe who is logged in and out of the facility and whether or not employees must display identification badges upon entry. If plant employees are issued uniforms by color or design, which designate their work station locations, also describe;
- Determine whether visitors, contractor representatives, cleaning crews, etc., are subject to movement tracking or control, and if any were present during production of the suspect product;
- If the suspect product was particularly vulnerable to in-plant tampering during certain stages of handling, identify particular employees who had access to product during these stages and interview them individually. There may be occasions when line employees may be able to remember suspicious activities on the part of co-workers or others working in the area when suspect lots were being produced;
- Describe the security measures taken for the processing area after hours, during work breaks, and at meal times. Be alert to those periods when in-process containers are left unattended on a packing/production line; and
- Describe any employee relations problems such as layoffs, firings, probations, adverse actions, etc.
Occasionally, your investigation may require you to obtain information not specifically authorized under the FD&C Act, e.g., distribution records of food products, production records for cosmetics or foods, etc. Seek to obtain such records if the following criteria have been met, or if, in the opinion of your supervisor, district, or headquarters, it is necessary to do so:
- The apparent counterfeiting/tampering incident may be serious and is assigned a high priority by your supervisor, district and/or agency, and;
- The data sought is normally of the type FDA is trained to evaluate and have access to in other areas of routine FD&C Act activities, e.g., production records, formulas, distribution records, etc., and;
- The requested data is likely to be necessary to the successful resolution of the investigation, and;
- Other alternatives to obtain the information are not as readily available.
If a request for data is made, you should direct it to the most responsible individual at the location. Explain clearly and concisely your need for the data. Do not issue a written request unless you have specific supervisory/district concurrence to do so.
All refusals encountered during counterfeiting/tampering investigations should be documented using existing procedures. Refusals of requests should include documentation the criteria in IOM 8.8.6 were met and the firm was aware of the non-routine nature of the request. The lack of precedent in this area suggests thorough documentation to allow appropriate compliance review and follow-up. A search warrant, subpoena or other court order may be appropriate in some circumstances. The feasibility and necessity of these actions should be discussed with the OCI before such action is initiated.
See IOM 1.1 English language requirement. Complete the FACTS Consumer Complaint Report and the FACTS Complaint Follow-up Report for all counterfeiting/tampering complaints received. See IOM Exhibits 8-2 and 8-3.
All completed and/or resolved reports of counterfeiting/tampering incidents should be provided to the OCM/OEO (HFA-615) to develop background information for agency use. If the investigation is of a continuing nature, OCM/OEO may require interim reports on a case by case basis.
Note: Time reporting should occur through FACTS.
Counterfeiting/Tampering reports should be reported in FACTS using the following guidelines:
Counterfeiting: Use the Problem Keyword “ OR” (for “Other”) and “ counterfeit ” in the Problem Keyword Detail field when recording complaints about counterfeiting in FACTS.”
Tampering: Use the Problem Keyword “TM.” It should be followed by a brief description of the problem such as "tamper evident seal missing” or “foreign capsules in bottle”.