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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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10-4 - INSPECTION OF FOOD RECORDS - SECTIONS 414(a) and 704(a)

10-4 - INSPECTION OF FOOD RECORDS - SECTIONS 414(a) and 704(a)
      10-4-1 - Purpose
      10-4-2 - Authority
      10-4-3 - Statutory requirements for invoking records inspection authority
      10-4-4 - Records that may be accessed and copied under this authority
      10-4-5 - Records that may not be accessed and copied under this authority
      10-4-6 - Procedure for Invoking Records Inspection Authority
      10-4-7 - Issuing the FDA 482c
      10-4-8 - Timeframes for compliance
      10-4-9 - Failure to provide records

10-4 - INSPECTION OF FOOD RECORDS – SECTIONS 414(a) and 704(a)

10-4-1 - Purpose

This section describes the authority, criteria, and procedure for inspecting records under sections 414(a) and 704(a) of the Federal Food, Drug, and Cosmetic Act.

10-4-2 - Authority

  1. The Federal Food, Drug, and Cosmetic Act:
    1. Section 414(a) Records Inspection –  Criteria for records access, see 10-4-3 below.
    2. Section 414(b)-  Authority to issue regulations to establish requirements for the establishment and maintenance of records needed to determine the immediate previous sources and the immediate subsequent recipients of food. See 21 CFR 1.326 -1.368.
    3. Section 414(c)- Protection of sensitive information. FDA shall take appropriate measures to ensure that effective procedures are in place to prevent the unauthorized disclosure of any trade secret or confidential information that is obtained by FDA pursuant to section 414.
    4. Section 414(d) Limitations- This section shall not be construed -- (1) to limit the authority of FDA to inspect records or require establishment and maintenance of records under any other provision of this Act; (2) to authorize FDA to impose any requirements with respect to a food to the extent that it is within the exclusive jurisdiction of the Secretary of Agriculture pursuant to the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq); (3) to have any legal effect on section 552 of title 5, United States Code, or section 1905 of title 18, United States Code; or (4) to extend to recipes for food, financial data, pricing data, personnel data, research data, or sales data (other than shipment data regarding sales).
    5. Section 704(a)(1)(B)- Requirement that, during an inspection, any person (excluding farms and restaurants) who manufacturers, processes, packs, transports, distributes, holds, or imports foods provide access to all records and other information described in section 414, when the criteria for records inspection in section 414(a)(1) or (a)(2) are satisfied, subject to the limitations in section 414(d).
    6. Section 301(e)- Authority to treat the refusal to permit access to or copying of any record required by section 414 or 704(a) or the failure to establish or maintain any record required by section 414(b) as prohibited acts.
  2. 21 CFR 1.361  What are the Record Availability Requirements?- When FDA has a reasonable belief that an article of food, and any other article that FDA reasonably believes is likely to be affected in a similar manner, is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, or when FDA believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that the FDA reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals, any records and other information accessible to FDA under section 414 or 704(a) of the Act must be made readily available for inspection and photocopying or other means of reproduction. Such records and other information must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the request.

10-4-3 - Statutory requirements for invoking records inspection authority

FDA can invoke its authority to access and copy records when the statutory requirements in section 414(a)(1), 414(a)(2), or section 704 of the Act are satisfied, whether or not intentional adulteration is known or suspected.

  • Section 414(a)(1) Adulterated Food - If FDA has a reasonable belief that an article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, FDA has authority to access and copy all records relating to such articles that are needed to assist FDA in making this determination.
  • Section 414(a)(2) Use of or Exposure to Food of Concern - If FDA believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals, FDA has authority to access and copy all records relating to such article, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, that are needed to assist FDA in making this determination. 

Sections 414(a)(1) and 414(a)(2) apply to any person - excluding farms and restaurants - who manufactures, processes, packs, distributes, receives, holds, or imports such article of food. Appropriate credentials and a written notice must be presented and the request for records must be conducted at reasonable times, within reasonable limits, and in a reasonable manner. See 10-4-7.

For foreign firms, section 414 applies to any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports such article intended for U.S. commerce. 

10-4-4 - Records that may be accessed and copied under this authority

FDA may access and copy all records, as authorized under section 414 and 704 relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of the article of food that are maintained by or on behalf of an entity in any format (including paper and electronic formats) and at any location, which are needed to meet the criteria in section 414(a)(1) or (a)(2). See 21 CFR 1.326.

The Investigator should initially request and review the records most likely needed to establish adulteration and serious adverse health consequences or death to humans or animals. See sections 414(a)(1) and (a)(2). The Investigator, as appropriate, should extend the review to other necessary records.

10-4-5 - Records that may not be accessed and copied under this authority

FDA's authority under sections 414 and 704(a) of the Act does not apply to: recipes for food, financial data, pricing data, personnel data, research data (except test marketing a food), or sales data (other than shipment data regarding sales), all of which are excluded under section 414(d). In addition, FDA may not access records from farms and restaurants. See 21 CFR 1.362.

In 21 CFR 1.328, "recipe" is defined as “the formula, including ingredients, quantities, and instructions necessary to manufacture a food product. Because a recipe must have all three elements, a list of the ingredients used to manufacture a product without quantity information and manufacturing instructions is not a recipe." Accordingly, FDA has authority to access such a list of ingredients in a records request.

10-4-6 - Procedure for Invoking Records Inspection Authority

The District must obtain OE concurrence in accordance with the procedures below before making a request to any person for access to records under sections 414(a) and 704(a).

  1. FDA's Office of Emergency Operations (OEO) will coordinate activities to obtain OE concurrence on a records request and should be initially contacted as follows:
    1. During a domestic inspection, District or other FDA personnel notifies FDA's Emergency Operations Center (OEO at 301-443-1240 – 24 hours/day), which the emergency response activities associated with a food that may present a threat of serious adverse health consequences or death to humans or animals.
    2. During a foreign inspection, the FDA investigator conducting the inspection notifies the Director, Division Foreign Field Investigations (DFFI). DFFI then notifies OEO.

      Note: Steps 2-6 may occur concurrently or sequentially:
       
  2. OEO notifies the appropriate Center (CFSAN and/or CVM) and the Office of Enforcement (OE) in the Office of Regulatory Affairs (either verbally or in writing).
  3. The appropriate Center, with the concurrence of OE, determines that there is a reasonable belief that the food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, or that there is a reasonable probability that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals.
  4. OE concurs with any requests for access to records, and works with the appropriate Center to determine the scope of the request and ensures the requested records are necessary to assess whether the food, and any other food that FDA reasonably believes is likely to be affected in a similar manner, is adulterated and presents a threat of serious adverse health consequences or death to humans or animals or whether there is a reasonable probability that the use of or exposure to the food, and any other food that FDA reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals.
  5. The appropriate Center consults with the Office of Chief Counsel (OCC) on the determination of whether there is a reasonable belief that the food is adulterated. OE will consult with the appropriate Center and OCC in determining the scope of the records request.
  6.  After the final determination is made, the appropriate Director shall memorialize the decision in writing. See SMG 1410.306.
  7. Once all the necessary determinations are made, OE conveys the information to the District Director for the facility being inspected (domestic inspection) or the Director, DFFI (foreign inspection). The Director, DFFI will convey the information to the appropriate Foreign Office Director or to the DFFI Foreign inspection cadre member.

10-4-7 - Issuing the FDA 482c

After the necessary determination has been made in accordance with the procedures in section 10-4-6 above, an investigator or other authorized FDA personnel upon presentation of credentials will issue a written notice, Form FDA 482c, to the owner, operator, or agent in charge, informing that person of the records requested and FDA's legal authority to obtain such records. FDA may request additional records related to the implicated food at a later time under the same authority.

10-4-8 - Timeframes for compliance

For all persons except foreign firms, records and other information requested under this authority must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the request. 21 CFR 1.361.

10-4-9 - Failure to provide records

The refusal to permit access to or copying of any record required by section 414 or 704(a) and the failure to establish or maintain any record required by section 414(b) are prohibited acts under section 301(e) of the Act. See 21 CFR 1.363.