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e-CFR data is current as of March 5, 2021

Title 21Chapter ISubchapter BPart 121Subpart D → §121.315

Title 21: Food and Drugs
Subpart D—Requirements Applying to Records That Must Be Established and Maintained

§121.315   Requirements for record retention.

(a)(1) All records required by this part must be retained at the facility for at least 2 years after the date they were prepared.

(2) Records that a facility relies on during the 3-year period preceding the applicable calendar year to support its status as exempt as a very small business must be retained at the facility as long as necessary to support the status of a facility as a very small business during the applicable calendar year.

(b) The food defense plan must be retained for at least 2 years after its use is discontinued.

(c) Except for the food defense plan, offsite storage of records is permitted if such records can be retrieved and provided onsite within 24 hours of request for official review. The food defense plan must remain onsite. Electronic records are considered to be onsite if they are accessible from an onsite location.

(d) If the facility is closed for a prolonged period, the food defense plan may be transferred to some other reasonably accessible location but must be returned to the facility within 24 hours for official review upon request.

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