21 CFR 123.9: Records

(a)General requirements. All records required by this part shall include:

(1)The name and location of the processor or importer;

(2)The date and time of the activity that the record reflects;

(3)The signature or initials of the person performing the operation; and

(4)Where appropriate, the identity of the product and the production code, if any. Processing and other information shall be entered on records at the time that it is observed.

(b)Record retention. (1) All records required by this part shall be retained at the processing facility or importer's place of business in the United States for at least 1 year after the date they were prepared in the case of refrigerated products and for at least 2 years after the date they were prepared in the case of frozen, preserved, or shelf-stable products.

(2)Records that relate to the general adequacy of equipment or processes being used by a processor, including the results of scientific studies and evaluations, shall be retained at the processing facility or the importer's place of business in the United States for at least 2 years after their applicability to the product being produced at the facility.

(3)If the processing facility is closed for a prolonged period between seasonal packs, or if record storage capacity is limited on a processing vessel or at a remote processing site, the records may be transferred to some other reasonably accessible location at the end of the seasonal pack but shall be immediately returned for official review upon demand.

(c)Official review. All records required by this part and all plans and procedures required by this part shall be available for official review and copying at reasonable times.

(d)Public disclosure. (1) Subject to the limitations in paragraph (d)(2) of this section, all plans and records required by this part are not available for public disclosure unless they have been previously disclosed to the public as defined in § 20.81 of this chapter or they relate to a product or ingredient that has been abandoned and they no longer represent a trade secret or confidential commercial or financial information as defined in § 20.61 of this chapter.

(2)However, these records and plans may be subject to disclosure to the extent that they are otherwise publicly available, or that disclosure could not reasonably be expected to cause a competitive hardship, such as generic-type HACCP plans that reflect standard industry practices.

(e)Tags. Tags as defined in § 123.3(t) are not subject to the requirements of this section unless they are used to fulfill the requirements of § 123.28(c).

(f)Records maintained on computers. The maintenance of records on computers is acceptable, provided that appropriate controls are implemented to ensure the integrity of the electronic data and signatures.