21 CFR 117.150 - Corrective Actions and Corrections

What it says

The facility must establish written corrective action procedures to follow when a preventive control is not properly implemented, including identifying and correcting the problem, reducing the likelihood it will recur, evaluating all affected food for safety, and preventing food that may be adulterated from entering commerce, and must keep records of the actions taken.

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

What it means in practice

• The requirement covers both fixing the immediate problem and learning from it, in the same spirit as CAPA in other regulated industries.
• A key step is deciding what to do with the affected product, and food that cannot be shown to be safe must not reach commerce.
• A minor, unanticipated problem may be handled as a correction, but repeated problems point to a plan that needs reanalysis.

What FDA inspectors look for

• Whether written corrective action procedures exist and were followed when a control deviated.
• Whether affected product was evaluated and its disposition documented.
• Whether repeated deviations led to a review of the control or the hazard analysis.

Related regulations