21 CFR Part 7 - Enforcement Policy and Recalls

What it says

Part 7 sets out FDA policy on recalls, which are voluntary actions by firms to remove or correct products that violate law. Subpart C provides guidance on firm-initiated recalls, covering recall strategy, classification by health hazard (Class I, II or III), depth of recall, public notification and effectiveness checks, and requires firms to notify FDA of recalls.

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

What it means in practice

• A recall procedure should be written and tested before it is needed, with clear roles and contact details.
• Traceability of lots to customers determines how quickly and completely a recall can be carried out.
• FDA classifies the recall, but the firm is expected to evaluate the hazard and start the action promptly.

What FDA inspectors look for

• Whether a recall procedure exists and has been exercised.
• Whether distribution records allow product to be traced quickly.
• Whether past recalls were handled, documented and checked for effectiveness.

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