Manufactured food establishments are required to establish and maintain applicable records based on the process being conducted. The requirements for establishing and maintaining records can be found in Title 21, Part 117, Subpart F, Code of Federal Regulations (CFR).
The following is a brief overview of the requirements:
Records must:
The owner, operator or agent in charge must sign and date:
Records must be retained for a minimum of two years after the date they were prepared or one year after the date of expiry (of the product), whichever is later.
Records must be made promptly available on written or oral request. The regulation allows for the food safety inspector to review and copy records. Those copies are often removed offsite, which is to assist in the evaluation of compliance with the regulation. All requested copies will be returned to the manufactured food establishment at the end of the inspection. However, if the record is determined to be necessary as supporting documentation to a violative condition, a copy of record will be kept and added to the inspection report.
Records are subject to disclosure requirements pursuant to local laws.
Existing records (e.g., records that are kept to comply with other federal, state or local regulations, or for any other reason) do not need to be duplicated if they contain all of the required information and satisfy the requirements of 21 CFR 117 Subpart F.