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Regulatory Procedures Manual 2008
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10-4 - INSPECTION OF FOOD RECORDS - SECTIONS 414(a) and 704(a)
     10-4-1 - Purpose
     10-4-2 - Authority
     10-4-3 - Criteria 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.

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10-4-2 - Authority

  1. The Federal Food, Drug, and Cosmetic Act (the Act):
    1. Section 414(a) "Records Inspection" - If 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, FDA can access and copy all records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of the food that are needed to assist the Secretary in making such a determination -- with the following exclusions and conditions:
      1. Applies to any person - excluding farms and restaurants - who manufactures, processes, packs, distributes, receives, holds, or imports an article meeting the above criteria.
      2. Applies to all records maintained by or on behalf on such person in any format and at any location -  excluding recipes, financial data, pricing data, personnel data, research data, and sales data (other than shipment data regarding sales).  Section 414(d)(4).
      3. Appropriate credentials and a written notice must be presented and the inspection must be conducted at reasonable times, within reasonable limits, and in a reasonable manner.  See "Issuing the FDA 482c" below.
    2. Section 414(b) provides authority for the Secretary to promulgate 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. These regulations are found in 21 CFR Part 1, Subpart J, §§ 1.326 through 1.368.
    3. Section 704(a) requires any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods to provide access to all records and other information described in section 414 when 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.
    4. Section 301(e) makes it a prohibited act to refuse to permit access to or copying of any record required by section 414; or to fail to establish or maintain any record required by section 414(b).
  2. 21 CFR §§ 1.326 through 1.368. These regulations require the establishment and maintenance of records needed to determine the immediate previous sources and the immediate subsequent recipients of food; and require records to be made available, as follows:
    1. 21 CFR 1.361 - When FDA 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, 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.

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10-4-3 - Criteria for Invoking Records Inspection Authority

The authority to access and copy records can be invoked whenever the statutory criteria are satisfied, whether or not intentional adulteration is known or suspected.   That is, FDA can access and copy records 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.

The authority to access and copy records can not be invoked unless the statutory criteria above are satisfied.

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

Records associated with an article(s) of food that meet the statutory criteria may be requested.   These records may be related to the manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of such food that are maintained by or on behalf of an entity subject to the recordkeeping regulation.   The records may be in any format (including paper and electronic formats) and at any location.   Because the circumstances of a particular event are case specific, the scope of a record request will vary on a case-by-case basis.   Depending upon the circumstances, the authority under sections 414(a) and 704(a) of the Act may apply to some or all records that are required to be kept by regulation under section 414(b) to determine the immediate previous sources and the immediate subsequent recipients of food.

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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 records excluded under section 414(d) (e.g., recipes for food, financial data, pricing data, personnel data, research data, or sales data other than shipment data regarding sales) and records from farms and restaurants.   21 CFR 1.328 defines a "recipe" 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. 

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

Concurrence must be obtained in accordance with the procedures below before making a request to any party for access to records under sections 414(a) and 704(a).

  1. District (or other FDA) personnel notify FDA's Emergency Operations Center (EOC at 301-443-1240 - 24 hours/day), which coordinates the emergency response activities associated with a food article that may present a threat of serious adverse health consequences or death to humans or animals.

    (Note:  Steps 2-6 may occur concurrently or sequentially)
  2. EOC 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 an article of food is adulterated and that the food presents a threat of 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 ensure the requested records are necessary to assess whether a food is adulterated and presents a threat of 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 an article of food is adulterated. OE will consult with OCC on the scope of the records request.
  6. Once all the necessary determinations are made, OE conveys the information to the Director of the district in which the facility being inspected is located.

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10-4-7 - Issuing the FDA 482c

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

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10-4-8 - Timeframes for compliance

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.

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10-4-9 - Failure to provide records

The refusal to permit access to or copying of any record required by section 414, or the failure to establish or maintain any record required by section 414(b) is prohibited under Section 301(e) of the Act.

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