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FDA Inspections
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Item Number: NWRR0303
A procedure that describes the guidelines and procedures used during inspections by the Food and Drug Administration (FDA). The procedure includes: a general discussion of FDA’s authority and types of FDA reports and regulatory actions; coordinating and facilitating the inspection; telephone inspections; inspection reports; inspection facilitator’s inspection report; response to inspection observations; and corrective actions and follow-up. The procedure applies to all visits by FDA inspectors regardless of the type of FDA inspection being conducted. This 12-page document assigns responsibility for each step of the procedure.
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