21 CFR Part 1 Subpart J - Establishment and Maintenance of Records

What it says

Persons who manufacture, process, pack, transport, distribute, receive, hold or import food must keep records identifying the immediate previous source of the food and the immediate subsequent recipient, often called one step back and one step forward. Records must be available to FDA within a set time of a request when FDA believes food presents a threat of serious adverse health consequences or death, and must be kept for the required period. Certain persons, such as farms and retailers, have partial exemptions.

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

What it means in practice

• Traceability depends on being able to link incoming ingredients to outgoing lots.
• Records must be retrievable quickly, so storage and indexing matter.
• Transporters have records obligations too, not just manufacturers.

What FDA inspectors look for

• Whether sources and recipients can be identified from records.
• Whether records can be provided within the time required.
• Whether records are kept for the required period.

Related regulations