What happens during an FDA food plant inspection?

FDA investigators show their credentials and hand a Notice of Inspection (FDA Form 482) to the owner, operator or agent in charge. They then interview management, walk through the plant, request records and may collect samples.

The FDA may inspect as part of a routine investigation, a survey or a response to a reported problem. The opening interview checks administrative and operational details, such as hours and the sanitation schedule. During the walk-through, investigators observe processes and may review procedures and talk to employees. If they collect samples, the FDA suggests telling them whether the firm will voluntarily hold product until results come back. At the end, they discuss findings with management and, if there are significant observations, leave a written list: the FDA Form 483. The FDA recommends having staff available to answer questions and provide documents, and responding in writing with corrective actions within 15 working days of the inspection's close.