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(a) General requirements for records. (1) You must keep records as original paper or electronic records or true copies (such as photocopies, pictures, scanned copies, or other accurate reproductions of the original records). Electronic records may include valid, working electronic links to the information required to be maintained under this subpart.
(2) All records must be legible and stored to prevent deterioration or loss.
(b) Establishment and maintenance of records by another entity. You may have another entity establish and maintain records required under this subpart on your behalf, but you are responsible for ensuring that such records can be retrieved and provided onsite within 24 hours of request for official review.
(c) Record availability. (1) You must make all records required under this subpart available to an authorized FDA representative, upon request, within 24 hours (or within some reasonable time to which FDA has agreed) after the request, along with any information needed to understand these records, such as internal or external coding systems, glossaries, abbreviations, and a description of how the records you provide correspond to the information required under this subpart.
(2) Offsite storage of records is permitted if such records can be retrieved and provided onsite within 24 hours of request for official review. Electronic records are considered to be onsite if they are accessible from an onsite location.
(3) When necessary to help FDA prevent or mitigate a foodborne illness outbreak, or to assist in the implementation of a recall, or to otherwise address a threat to the public health, including but not limited to situations where 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) presents a threat of serious adverse health consequences or death to humans or animals as a result of the food being adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act, you must make available, within 24 hours (or within some reasonable time to which FDA has agreed) of a request made in-person or remotely (e.g., by phone) by an authorized FDA representative, the information you are required to maintain under this subpart, for the foods and date ranges or traceability lot codes specified in the request.
(i) If FDA's request for the information specified in paragraph (c)(3) of this section is made by phone, we will also provide the request to you in writing upon your request; however, you must provide the requested information within 24 hours (or within some reasonable time to which FDA has agreed) of the phone request.
(ii) Except as specified in paragraph (c)(3)(iii) and (iv) of this section, when the information requested by FDA under paragraph (c)(3) of this section is information you are required to maintain under §§ 1.1325 through 1.1350, you must provide such information in an electronic sortable spreadsheet, along with any other information needed to understand the information in the spreadsheet.
(iii) You may provide the information requested by FDA under paragraph (c)(3) of this section in a form other than an electronic sortable spreadsheet if you are:
(A) A farm whose average annual sum of the monetary value of their sales of raw agricultural commodities and the market value of raw agricultural commodities they manufacture, process, pack, or hold without sale (e.g., held for a fee) during the previous 3-year period is no more than $250,000 (on a rolling basis), adjusted for inflation using 2020 as the baseline year for calculating the adjustment;
(B) A retail food establishment or restaurant with an average annual monetary value of food sold or provided during the previous 3-year period of no more than $1 million (on a rolling basis), adjusted for inflation using 2020 as the baseline year for calculating the adjustment; or
(C) A person (other than a farm, retail food establishment, or restaurant) whose average annual sum of the monetary value of their sales of food and the market value of food they manufacture, process, pack, or hold without sale (e.g., held for a fee) during the previous 3-year period is no more than $1 million (on a rolling basis), adjusted for inflation using 2020 as the baseline year for calculating the adjustment.
(iv) FDA will withdraw a request for an electronic sortable spreadsheet under paragraph (c)(3)(ii) of this section, as appropriate, to accommodate a religious belief of a person asked to provide such a spreadsheet.
(4) Upon FDA request, you must provide within a reasonable time an English translation of records required under this subpart maintained in a language other than English.
(d) Record retention. Except as specified otherwise in this subpart, you must maintain records containing the information required by this subpart for 2 years from the date you created or obtained the records.
(e) Electronic records. Records that are established or maintained to satisfy the requirements of this subpart and that meet the definition of electronic records in § 11.3(b)(6) of this chapter are exempt from the requirements of part 11 of this chapter. Records that satisfy the requirements of this subpart, but that also are required under other applicable statutory provisions or regulations, remain subject to part 11 of this chapter, if not otherwise exempt.
(f) Use of existing records. You do not need to duplicate existing records you have (e.g., records that you keep in the ordinary course of business or that you maintain to comply with other Federal, State, Tribal, territorial, or local regulations) if they contain the information required by this subpart. You may supplement any such existing records as necessary to include all of the information required by this subpart.
(g) Use of multiple sets of records. You do not have to keep all of the information required by this subpart in a single set of records. However, your traceability plan must indicate the format and location of the records you are required to keep under this subpart, in accordance with § 1.1315(a)(1).
(h) Public disclosure. Records obtained by FDA in accordance with this subpart are subject to the disclosure requirements under part 20 of this chapter.
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