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Title 21

Displaying title 21, up to date as of 9/17/2021. Title 21 was last amended 9/17/2021.

Title 21

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§ 1.510 How must I maintain records of my FSVP?

(a) General requirements for records.

(1) You must keep records as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records.

(2) You must sign and date records concerning your FSVP upon initial completion and upon any modification of the FSVP.

(3) All records must be legible and stored to prevent deterioration or loss.

(b) Record availability.

(1) You must make all records required under this subpart available promptly to an authorized FDA representative, upon request, for inspection and copying. Upon FDA request, you must provide within a reasonable time an English translation of records maintained in a language other than English.

(2) Offsite storage of records, including records maintained by other entities in accordance with § 1.504, § 1.505, or § 1.506, 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) If requested in writing by FDA, you must send records to the Agency electronically, or through another means that delivers the records promptly, rather than making the records available for review at your place of business.

(c) Record retention.

(1) Except as specified in paragraph (c)(2) of this section, you must retain records referenced in this subpart until at least 2 years after you created or obtained the records.

(2) You must retain records that relate to your processes and procedures, including the results of evaluations and determinations you conduct, for at least 2 years after their use is discontinued (e.g., because you no longer import a particular food, you no longer use a particular foreign supplier, you have reevaluated the risks associated with a food and the foreign supplier, or you have changed your supplier verification activities for a particular food and foreign supplier).

(d) 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.

(e) Use of existing records.

(1) You do not need to duplicate existing records you have (e.g., records that you maintain to comply with other Federal, State, or local regulations) if they contain all of 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.

(2) You do not need to maintain the information required by this subpart in one set of records. If existing records you have contain some of the required information, you may maintain any new information required by this subpart either separately or combined with the existing records.

(f) Public disclosure. Records obtained by FDA in accordance with this subpart are subject to the disclosure requirements under part 20 of this chapter.