21 CFR Part 113 - Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers

What it says

Processors of low-acid foods packaged in hermetically sealed containers must operate under scheduled processes established by a competent processing authority, use trained and supervised retort operators, maintain required process equipment and instruments, examine container closures, code containers, keep processing and production records, and handle deviations in processing by evaluating the product and, where needed, reprocessing or destroying it. Facility registration and process filing are required under 21 CFR Part 108.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The main hazard is Clostridium botulinum, so the scheduled process, the time and temperature that achieves commercial sterility, is the critical control.
• Container closure integrity matters because a defective seal can allow contamination after processing.
• A process deviation, such as a retort temperature drop, triggers a defined evaluation, and the product cannot simply be released.

What FDA inspectors look for

• Whether the processing authority's scheduled process is on file and followed exactly.
• Whether retort operators are trained as required and records are complete.
• Whether deviations were evaluated and documented properly.

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