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ContentsSUBCHAPTER 970 - COUNTERFEITING/TAMPERING971 - REPORTING CONTACTS 971.01 - OCM / EOC RESPONSIBILITY 972 - COORDINATION WITH OTHER GOVERNMENT AGENCIES 973 - AUTHORITY & RESPONSIBILITY 974 - RELEASE OF INFORMATION 975 - INVESTIGATION 975.01 - General Procedures 975.02 - Interviews 975.03 - Sampling 975.04 - Complainants 975.05 - Retail Stores 975.06 - Manufacturer and Distribution System Follow-up 976 - RECORD REQUESTS 977 - REFUSALS 978 - REPORTING SUBCHAPTER 970 - COUNTERFEITING/TAMPERING971 - REPORTING CONTACTS
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)
(301-294-4030) and the Office of Crisis Management (OCM)/Emergency
Operations Center (EOC), HFA-615, (301-443-1240).
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/EOC immediately. 971.01 - OCM / EOC RESPONSIBILITYOCM/EOC is the focal point for communications; especially in those counterfeiting/tampering cases where regional/national coverage is necessary. Alert the EOC 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. 972 - COORDINATION WITH OTHER GOVERNMENT AGENCIESFederal - The Federal Bureau of Investigations (FBI) and the USDA share enforcement of the Federal Anti-Tampering Act (FATA) with FDA as described below:
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 973. Assistance should be provided to cooperating officials as necessary or where requested. 973 - AUTHORITY & RESPONSIBILITYFDA 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 970-A.) 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 510.01 — Personal Safety, and IOM 510.03 Situational Plan, for more information. 974 - RELEASE OF INFORMATIONInformation 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/EOC office.
See IOM
161 and 971.01 for
additional information concerning dealing with the media in investigative
matters. 975 - INVESTIGATIONThe 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 973. 975.01 - General Procedures
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:
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/EOC. 975.02 - InterviewsIt 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.
975.03 - Sampling1. 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 SCIENCE" http://www.fbi.gov/hq/lab/handbook/intro.htm which has been 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. 2. 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.counterfeiting/ 975.04 - ComplainantsWhen 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 law suits 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 433. 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. 975.05 - Retail StoresWhen 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. 975.06 - Manufacturer and Distribution System Follow-upThe 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: Manufacturing Sites
Distribution Facilities - It may be necessary to obtain the following information at each level in the distribution chain:
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. Security - 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.
976 - RECORD REQUESTSOccasionally, 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 OTC drugs 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:
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. 977 - REFUSALSAll refusals encountered during counterfeiting/tampering investigations should be documented using existing procedures. Refusals of requests should include documentation the criteria in IOM 976 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.978 - REPORTINGSee IOM 100 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 900-A & 900-B. All completed and/or resolved
reports of counterfeiting/tampering incidents should be provided to
the OCM/EOC (HFA-615) to develop background information for agency
use. If the investigation is of a continuing nature, OCM/EOC may require
interim reports on a case by case basis. 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 ”.
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