Inspections, Compliance, Enforcement, and Criminal Investigations
SUBCHAPTER 2.2 - STATUTORY AUTHORITY
- 2.2.3 - OTHER ACTS
- 188.8.131.52 - Anabolic Steroids Control Act of 1990
- 184.108.40.206 - Fair Packaging and Labeling Act (FPLA)
- 220.127.116.11 - Federal Anti-Tampering Act
- 18.104.22.168 - Federal Import Milk Act
- 22.214.171.124 - Federal Caustic Poison Act
- 126.96.36.199 - Poison Prevention Packaging Act
- 188.8.131.52 - Public Health Service Act (PHS)
- 184.108.40.206 - Mammography Quality Standards Act of 1992
- 220.127.116.11 - Comprehensive Smokeless Tobacco Health Education Act
- 18.104.22.168 - Federal Cigarette Labeling & Advertising Act
- 2.2.5 - DEFINITIONS
- 22.214.171.124 - Civil Number
- 126.96.36.199 - Citation (Cite)
- 188.8.131.52 - Criminal Number
- 184.108.40.206 - FDC and INJ Numbers
- 220.127.116.11 - Complaint For Forfeiture
- 18.104.22.168 - Home District
- 22.214.171.124 - Nolle Prosequi (Nol-Pros)
- 126.96.36.199 - Nolo Contendere (Nolo)
- 188.8.131.52 - Seizing District
- 184.108.40.206 - Subpoena Duces Tecum
- 220.127.116.11 - Supervising District
Various acts specify the authority conferred on the Secretary of DHHS. This authority is delegated by regulations to the Commissioner of Food and Drugs, and certain authorities are delegated further by him.
This Act, as amended, and its regulations provide the basic authority for most operations.
Examinations, Investigations, and Samples - Collecting samples is an important and critical part of FDA's regulatory activities. While inspections and investigations may precede sample collection, a case under the law does not normally begin until a sample has been obtained. Proper sample collection is the keystone of effective enforcement action.
The basic authority for FDA to take samples falls under the statutory provisions of section 702(a) of the FD&C Act [21 USC 372(a)], which authorizes examinations and investigations for the purposes of this Act.
For tobacco products, section 702(a)(1)(B) of the FD&C Act directs FDA to contract with states to inspect retailers within that state in connection with the enforcement of the Act when feasible.
Section 702(b) of the FD&C Act [21 USC 372(b)] requires FDA to furnish, upon request, a portion of an official sample for examination or analysis to any person named on the label of an article, the owner thereof, or his attorney or agent. In a precedent case, "United States v. 75 Cases, More or Less, Each Containing 24 Jars of Peanut Butter, the U.S. Circuit Court of Appeals for the Fourth Circuit held the taking of samples is authorized under section 702(b) of the FD&C Act [21 U.S.C. 372(b)], since this section "clearly contemplates the taking of samples." See Kleinfeld and Dunn 1938-1949 at 126. The FD&C Act also refers to samples in sections 704(c) and 704(d) [21 USC 374(c) and 374(d)].
Authority to Enter and Inspect - Section 704 of the FD&C Act [21 U.S.C. 374] provides the basic authority for establishment inspections. This authorizes you to enter, and to inspect at reasonable times, within reasonable limits, and in a reasonable manner, establishments or vehicles being used to process, hold or transport food, drugs, devices, tobacco products, or cosmetics. The statute does not define, in specific terms, the meaning of "reasonable". FDA's establishment inspection procedures maintain this authority extends to what is reasonably necessary to achieve the objective of the inspection.
Authority to inspect food plants resides in the general inspectional authority of section 704 of the FD&C Act [21 U.S.C. 374]. Section 306 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 ("the Bioterrorism Act") (PL 107-188), signed into law on June 12, 2002, created a new section 414, "Maintenance and Inspection of Records," in the FD&C Act. Under this new authority, the Secretary of Health and Human Services (the Secretary) may by regulation establish requirements for persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import food to establish and maintain food records. These records identify the immediate previous sources and the immediate subsequent recipients of food. In addition, section 414(a), "Records Inspection," and section 704(a), "Factory Inspection" authorize the Secretary to access and copy all records related to an article of food if: (1) the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, and (2) the records are necessary to assist the Secretary in making such a determination. FDA plans to carry out its authority to inspect all records and other information described in section 414 in a similar manner as FDA’s authority to perform inspections of facilities (i.e., upon presentation of appropriate credentials and a written notice at reasonable times, within reasonable limits, and a reasonable manner.) FDA employees will not invoke this authority during inspections unless the requirements for record access under the Bioterrorism Act are satisfied. Further guidance is available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
The Infant Formula Act of 1980 added new authority to the FD&C Act. Section 412 of the FD&C Act [21 U.S.C. 350a] extends the definition of adulteration to include specific nutritional, quality and good manufacturing control requirements. It also mandates a firm make available batch records, quality control records, nutrient test data and methodology, and similar documents for examination and copying. Section 704(a)(3) of the FD&C Act [21 U.S.C. 374(a)(3)] gives investigators the right to examine and copy these records.
Section 704(a) of the FD&C Act [21 U.S.C. 374(a)] provides the general inspectional authority to inspect medical device manufacturers. The Medical Device Amendments of 1976 provided additional authority to inspect records, files, papers, processes, controls, and facilities to determine whether restricted devices are adulterated or misbranded. The Amendments also provide FDA authority, under section 704(e) [21 U.S.C. 374(e)], to inspect and copy records required under section 519 or 520(g) of the FD&C Act [21 U.S.C. 360i or 360j(g)].
Section 704 of the FD&C Act [21 U.S.C. 374] provides authority for FDA to conduct inspections of factories, warehouses, establishments, and vehicles, and all pertinent equipment, finished and unfinished materials, containers, and labeling therein where food, drugs, devices, tobacco products, or cosmetics are manufactured or held. This section does not include a provision to inspect records within those facilities, except for inspections of prescription drugs, nonprescription drugs intended for human use, and restricted devices, or tobacco products as stipulated in 704(a)(1)(B) [21 U.S.C. 374(a)(1)(B)], or inspections of infant formula described in 704(a)(3) of the FD&C Act [21 U.S.C. 374(a)(3)].
Keep in mind that several other sections of the Act or of regulations also include provision for inspection and copying of required records. For example, 505(k) provides authority to access and copy records required for new drug applications and abbreviated new drug applications, 512(k)(2) and 512(m)(5) of the FD&C Act [21 U.S.C. 360b(k)(2) and 360b(m)(5)] provide access and copying of records regarding new animal drug and medicated feed permits, HACCP regulations in 21 CFR 123 for fish and fishery products provide for access and copying of required records, and 920(c) provides access, with written notice, to records in investigating potential illicit trade, smuggling, or counterfeiting of tobacco products.
Some firms will allow access to files and other materials for which the FD&C Act does not give mandatory access, but retain the right to later refuse. Management may propose the following alternatives:
- That inspections to obtain data from these files be made without issuing an FDA-482, Notice of Inspection. You cannot agree to this because the act requires the notice be issued before the inspection.
- That when data is provided, you are advised in writing it is being given voluntarily. In this instance accept the written or oral statement, and include it as part of the EIR.
Management may insist answers to specific questions be provided by the firm's legal department or other administrative officers. In some instances, management may request questions be submitted in writing. In these cases, try to obtain answers necessary to complete the inspection. Do not submit lists of questions unless specifically instructed to do so by your supervisor.
The authority for obtaining samples of radiation-emitting electronic products for testing is provided in Section 532(b)(4) of the FD&C Act [21 U.S.C. 360ii(b)(4)].
The authority to inspect factories, warehouses, and establishments where electronic products are manufactured or held is provided in Section 537(a) of the FD&C Act [21 U.S.C. 360nn(a)]. This authority is limited; FDA must find "good cause" that methods, tests, or programs related to radiation safety (such as noncompliance with a standard) may be inadequate or unreliable. If there is no finding of "good cause," inspections must be voluntary unless another authority, such as Section 704(a) of the FD&C Act [21 U.S.C. 374(a)] for medical devices, exists. The authority to inspect books, papers, records, and documents relevant to determining compliance with radiation standards is provided in Section 537(b) of the FD&C Act [21 U.S.C. 360nn(b)]. The Electronic Product Radiation Control prohibited acts and enforcement authorities are specified in Sections 538 and 539 of the FD&C Act [21 U.S.C. 360oo and 360pp].
The amendments to the FD&C Act are summarized in Regulatory Procedures Manual (RPM) chapter 2-2.
The Anabolic Steroids Control Act amends the Controlled Substances Act by adding Anabolic Steroids to Schedule III of section 202(c).
Fair Packaging and Labeling Act (FPLA) is an Act to prevent the use of unfair or deceptive methods of packaging or labeling of certain consumer commodities.
Federal Anti-Tampering Act prohibits certain tampering with consumer products (18 USC 1365). See IOM 8.8 for guidance on tampering investigations.
Federal Import Milk Act regulates the importation of raw and pasteurized bovine milk and cream from foreign producers.
Primarily a labeling Act specifying warnings and precautionary statements on labeling of certain household caustic preparations.
Provides for special packaging to protect children from serious personal injury or serious illness resulting from handling, using, or ingesting household substances.
Public Health Service Act (PHS) - Sampling: For biological products, which are also drugs under the FD&C Act, the sampling authority of both Acts exists.
Section 351(c) of Part F, Title III of the Public Health Service (PHS) Act [42 USC 262(c)] authorizes inspections of biological establishments (vaccines, serum, and blood). Authority to collect samples and records is found in 21 CFR 600.22. Section 361(a) of Part G of the PHS Act [42 USC 264] authorizes inspection and other activities for the enforcement of 21 CFR 1270, Human Tissue Intended for Transplantation, and 21 CFR 1240, Interstate Quarantine Regulations. Part 1240 covers the mandatory pasteurization for all milk in final package form intended for direct human consumption; the safety of molluscan shellfish; the sanitation of food service; and food, water, and sanitary facilities for interstate travelers on common carriers.
Mammography Quality Standards Act of 1992 amends the Public Health Service Act to establish the authority for the regulation of mammography services and radiological equipment.
Comprehensive Smokeless Tobacco Health Education Act mandates a program to inform the public of any dangers to human health resulting from the use of smokeless tobacco products and includes specific requirements for smokeless tobacco products’ labeling and advertising.
Federal Cigarette Labeling & Advertising Act requires a comprehensive federal program to deal with cigarette labeling and advertising to adequately inform the public of health risks and create a uniform regulatory structure across the United States. The Act includes specific requirements for cigarette for cigarette labeling and advertising.
The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. The Code is divided into 50 titles which represent broad areas subject to Federal regulation. Each title is divided into chapters which usually bear the name of the issuing agency. Each chapter is further subdivided into parts covering specific regulatory areas. For example, the specific regulation covering drug GMPs appears as "21 CFR 211", that is, Title 21, Part 211. Regulations enforced by FDA are found in volumes 1-8 of Title 21, parts 1-1299. They are updated as of April 1 of each year. The Federal Register and the CFR must be used together to determine the latest version of a given rule.
The following terms are used in assignments, correspondence, and various procedures described in this manual and used throughout FDA.
A docket number used by US district courts to identify civil cases (seizure and injunction).
The section 305 Notice is a statutory requirement of the FD&C Act. It provides a respondent with an opportunity to show cause why he should not be prosecuted for an alleged violation. Response to the notice may be by letter, personal appearance, or an attorney(s).
A docket number used by the US district courts to identify criminal cases (prosecutions).
The number used by the Chief Counsel's office to identify FDA cases.
A document furnished to the U.S. attorney for filing with the clerk of the court to initiate a seizure.
The Home District is the district in whose territory the alleged violation of the Act occurs, or in whose territory the firm or individual responsible for the alleged violation is physically located. The original point from which the article was shipped, or offered for shipment, as shown by the interstate records, is usually considered the point where the violation occurred; and the shipper of such article, as shown by such records, may be considered to be the alleged violator.
Where actions against a firm are based on goods which became violative after interstate shipment was made, or after reaching its destination (such as 301(k) violations), the dealer in whose possession the goods are sampled may be considered the violator, and the location of this dealer determines the "Home District".
The prosecutor or plaintiff in a legal matter will proceed no further in prosecuting the whole suit or specified counts.
A plea by a defendant in a criminal prosecution meaning "I will not contest it".
The district where seizure is actually accomplished. The seizing district is not necessarily the collecting district, as in the case of in transit samples.
A writ commanding a person to appear in court bringing with him certain designated documents or things pertinent to the issues of a pending controversy.
The district which exercises supervision over reconditioning lots in connection with seizure actions.
Seizure is a judicial civil action directed against specific offending goods, in which goods are "arrested." Originally designed to remove violative goods from consumer channels, it was intended primarily as a remedial step; however, the sanction often has a punitive and deterrent effect.
For more information on seizure actions consult RPM Chapter 6-1 “Seizures.”
The district considers all evidence, including any establishment inspection, sample collection, and analytical results. If indicated, seizure is recommended to headquarters.
Except for certain direct seizure authority, district seizure recommendations are referred to the appropriate center for approval. If approved, the case is referred to the Office of Enforcement and Import Operations (HFC-200) which then requests the Chief Counsel to initiate seizure action.
The Food and Drug Division of the Department's Office of Chief Counsel reviews and forwards the seizure action to the U.S. attorney in whose judicial district the violative goods are located, through the seizing district. The U.S. attorney files a Complaint for Forfeiture addressed to the U.S. district court, setting forth the facts of the case and calling for the "arrest" of the goods. This Complaint is filed with the appropriate district court.
The court orders the arrest of the goods by issuing a motion and warrant to the U.S. marshal, directing seizure of the goods.
The marshal seizes the goods, which then become the property of the court. You may be asked to assist the marshal in the seizure. If so, submit a memorandum to your district office covering this activity.
Any person who has an interest in the goods may appear as claimant or to intervene, and claim the goods.
If no claimant appears within a specified time, (return date), then the U.S. attorney requests a Default Decree of Condemnation and Forfeiture, in which the court condemns the goods and directs the U.S. marshal to destroy or otherwise dispose of the goods. Usually, the District assists the marshal in determining the method of disposal, and you may be asked to help in the actual disposition. Any disposition must be in accordance with the National Environmental Policy Act of 1969 (NEPA); 42 U.S.C. 4321-4347.
A claimant may appear and propose the goods be reconditioned to bring them into compliance. After the FDA agrees to the method of reconditioning, the court issues a Decree of Condemnation permitting reconditioning under the supervision of the FDA, after a bond is posted. Salvage operations may include:
- Cleaning, reworking, or other processing,
- Relabeling, or
A claimant may file an answer to the complaint and deny the allegations. The issues then go to trial.
The district monitors the progress of the seizure and forwards appropriate reports to Headquarters.
Prosecution is a criminal sanction directed against a firm and/or responsible individuals. They can be pursued at two levels: misdemeanor or felony. A prosecution is punitive, with the view of punishing past behavior and obtaining future compliance.
The section 305 Notice is a statutory requirement of the Act. It provides a respondent with an opportunity to explain why he should not be prosecuted for the alleged violation. Response to the notice may be by letter, personal appearance or attorney.
Under certain circumstances, the Agency will refer prosecution (or for further investigation) without first providing the opportunity for presentation of views in accordance with section 305 [See 21 CFR 7.84(a)(2) and (3)].
The facts developed at the hearing are reviewed, along with other evidence, and the district prepares a recommendation that the case be:
- Placed in permanent abeyance, with no further action, or
- Placed in temporary abeyance, in which case the decision is delayed pending additional evidence, or for other reasons, or
- Considered, with RFDD concurrence, for an ad hoc meeting when there is an indication of potential felony charges or the case is especially unusual, or
- Forwarded to the Justice Department for prosecution.
The district recommendation is reviewed by Headquarters units in the light of current policy and procedure. If prosecution is indicated, the case is forwarded to the Office of Chief Counsel (OCC) for review. If the Chief Counsel agrees, the matter is forwarded to the Department of Justice (DOJ) where it is reviewed again. If DOJ concurs, the case is forwarded to the appropriate U. S. Attorney. Non-concurrence results in return of the case to FDA.
An Information is a legal document filed in misdemeanor actions identifying the defendants and setting forth the charges. The Information is forwarded to the appropriate U.S. Attorney, who then files the legal instruments. A trial date is set by the court. Ideally, trial preparation is collaboration between representatives of the U. S. Attorney's office, OCC, the District and the involved Center.
The Justice Department must proceed by indictment in all felony cases. Evidence in possession of the government is presented to a grand jury which decides if it is sufficient to warrant prosecution. If the grand jury returns a "True Bill", and the defendant pleads not guilty at the arraignment, preparation for trial begins.
The deliberations of a federal grand jury are secret, and only those whom the court has placed under Rule 6(e) of the Federal Rules of Criminal Procedure may be privy to the grand juries activities. Consequently, if you have been designated under the Rule, you may not divulge your knowledge of grand jury affairs to anyone, including colleagues or supervisors, unless they, too, have been placed under the Rule. Strict adherence to the rule of grand jury secrecy protects not only the integrity of the government's investigation, and the validity of any indictment the grand jury might return, but the rights of the person accused. See IOM 18.104.22.168 Working with a Grand Jury.
When you are assigned to work with, or for, a grand jury and are instructed as part of that assignment to conduct an inspection or an investigation, do not issue a Notice of Inspection (FDA-482) (See IOM 22.214.171.124 Conducting Regulatory Inspections When the Agency is Contemplating Taking, or is Taking, Criminal Action). Check with district management and the Assistant U.S. Attorney or Chief Counsel Attorney involved, prior to initiating this type of assignment. Also, refer to IOM 126.96.36.199, 188.8.131.52, 184.108.40.206, 220.127.116.11, 18.104.22.168 and 22.214.171.124.
Appropriate reports are made to the Administration when the case terminates. Follow-up may involve inspections either of a routine nature or as directed by the court.
An injunction is a civil restraint issued by the court to prohibit violations of the Act. Injunction is designed to stem the flow of violative products in interstate commerce, and to correct the conditions in the establishment.
Injunction actions must be processed in strict time frames. Therefore, you may be requested to conduct an inspection to determine the current condition of a firm and to obtain specific information required for the injunction.
Upon presentation of evidence, the U.S. district court may issue an order restraining defendant from certain acts, for a specific length of time. This period may be extended by order of the court.
Prior to the expiration of the TRO, if one is involved, the U.S. Attorney, assisted by the district, presents evidence to support an injunction.
The defendants may, following conferences with the U.S. Attorney, consent to a decree of preliminary or permanent injunction. If not, the issue goes to trial.
A preponderance of evidence is required to support an injunction. This differs from a prosecution, which requires evidence establishing guilt "beyond a reasonable doubt". Trial is before the district court. There is no trial by jury, unless demanded by the defendant. In violations of injunction (contempt), the action is brought under the Rules of Criminal Procedure.
A preliminary or permanent injunction enjoins a firm or individuals from continuing a specific violation(s). The terms of the injunction specify the steps to be taken to correct the violations at issue.
Generally, the district will police an injunction to assure the terms of the decree are met. This may include routine inspections or actual supervision of compliance activities dictated by the terms of the injunction.
Section 404 of the FD&C Act [21 U.S.C. 344] provides for the issuance of temporary permits prescribing the conditions governing the manufacture, processing or packing of certain classes of foods. It applies to foods subject to contamination by injurious microorganisms, where such contamination cannot be adequately determined after such articles have entered interstate commerce.
FDA has administrative detention authority for food under section 304(h) of the FD&C Act [21 U.S.C. 334(h)], and for medical devices under section 304(g) of the FD&C Act [21 U.S.C. 334 (g)], when FDA has a reason to believe that the article is adulterated or misbranded.
FDA also has detention authority for certain products regulated by USDA under sections 402 and 409(b) of the Federal Meat Inspection Act, sections 19 and 24(b) of the Poultry Products Inspection Act, and sections 5(d), 19, and 23(d) of the Egg Products Inspection Act. See IOM 126.96.36.199 for information on these authorities.
In essence, articles subject to the Federal Meat Inspection Act or the Poultry Products Inspection Act that are believed to be adulterated or misbranded under the FD&C Act may be detained. FDA representatives may detain articles subject to the Egg Products Inspection Act, which are suspected to be in violation of that statute.
Devices may be detained under the FD&C Act for a maximum of thirty days when there is reason to believe they are adulterated or misbranded under the FD&C Act.
See IOM 2.7.2 for inspectional procedures, which must be followed, in exercising the detention authority.
Effective testimony, whether it be in court before a judge or jury, grand jury or opposing counsel at a deposition, is a result of quality investigative skills; the ability to prepare factual and informative investigative reports; and thorough preparation for being a fact witness.
As a witness, you are required to testify from memory, but you are allowed to refer to diary notes, reports and memoranda, when necessary to refresh your recollection. For this reason, and the fact they are available to opposing counsel, the Agency insists your notes, reports and the like always be accurate, organized and complete.
There is little difference in giving testimony in court, in a deposition or before a grand jury. In a deposition, testimony is given upon interrogation by opposing counsel, under oath, before a court reporter. Be guided by your (the Government's) attorney in preparing for a deposition. Once completed, the deposition is available to all persons interested in the case, and is available for use at trial.
In a grand jury, testimony is given under oath to a group of jurors who determine whether sufficient evidence exists to charge someone with a felony (See IOM 188.8.131.52).
The following suggestions may be helpful in preparing to provide testimony in court, before a grand jury or at a deposition:
- Carefully and thoroughly reviewing your diary notes, inspection reports and all samples collected.
- Be neat in your personal appearance; dress conservatively in business attire, and be well groomed.
- When you take the witness stand, get comfortable, sit erectly and carefully look around to familiarize yourself with the court surroundings.
- Tell the truth. If asked, do not hesitate to admit you have discussed your testimony in advance with the U.S. Attorney's office.
- Be sure you understand the question before you answer. If you don't understand the question, request clarification. Take your time. Give each question such thought as required to understand and formulate your answer. Do not answer questions too quickly. Give your attorney time to raise an objection in case it is a question you should not answer. Answer questions clearly and loudly enough so everyone can hear you. Look at the jury and address your remarks to it so all jury members will be able to hear and understand you. Speak directly and authoritatively, and do not use ambiguous phrases such as, "I guess so", "I believe," etc. Do not be afraid to say, "I don't know".
- Be polite and serious at all times. Give an audible answer to all questions. Do not nod your head yes or no.
- Do not lose your temper, even if baited by an attorney. Do not spar with examining attorneys; answer questions frankly, factually and confidently, then stop. Do not answer questions, which have been objected to until the court rules on the objection. Do not volunteer information.
- If you make a mistake answering a question, correct it immediately. If a question can't be truthfully answered with a yes or no, you have the right to explain your answer. If you are asked questions about distances, time or speed, and your answer is only an estimate, be sure you make that clear.
- If a recess is declared while you are on the stand, keep to yourself. Do not discuss your testimony with anyone except on special instructions from the U.S. Attorney or his/her assistant.
- Be natural, be yourself. Do not be intimidated by personalities.
Miranda Warning - In the Agency's normal course of operation, it is not necessary to read a person their rights, (i.e.: Miranda warnings) because the Agency does not routinely interview individuals who are in custody (under arrest). Miranda warnings are not necessary, during discussions with management when conducting inspections, during investigational interviews, or during a section 305 of the FD&C Act [21 U.S.C. 335] meeting because the individuals being interviewed are not in custody, and are free to leave at any time.
In certain situations, however, FDA personnel may interview someone who is already in custody. In this case, the individual must be given their Miranda rights.
When this situation is encountered, copy page 1 of IOM Exhibit 2-1. If the subject cannot speak/read English, you must arrange for a form in the appropriate language. Read this material to the individual, preferably in the presence of another person, and then have them sign and date the waiver statement. Submit the signed statement with your report. If the individual refuses to sign the statement, indicate this on the unsigned statement, and identify the witness on the document. Submit the unsigned statement with your report.