21 CFR 117.139 - Recall Plan

What it says

For food with a hazard requiring a preventive control, the facility must establish a written recall plan that includes procedures to notify direct consignees and, if appropriate, the public, to conduct effectiveness checks, and to appropriately dispose of recalled food.

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

What it means in practice

• A recall plan is written in advance, so the facility is not working out who does what for the first time during an actual event.
• Traceability records, such as lot codes and distribution records, determine how quickly the facility can find and remove affected product.
• Effectiveness checks confirm consignees received the notice and acted on it.

What FDA inspectors look for

• Whether a written recall plan exists and contains each required procedure.
• Whether lot coding and distribution records would let the facility trace product forward.
• Whether the plan was tested or exercised, for example through a mock recall.

Related regulations