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FDA Inspections of Sponsor Sites
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Item Number: NWRR3021
A procedure that describes general guidelines in the event the sponsor site is inspected by the Food and Drug Administration (FDA). This 15-page document includes: preparing for the inspection, commencement of the inspection, coordinating the inspection, and scope of the inspection; on-site and telephone inspections; FDA inspection reports; response to inspection observations; and corrective actions and follow-up. This document assigns responsibility for each step of the procedure and applies to FDA inspections that occur as a result of a clinical investigation that involve human subjects for which the company is the sponsor.
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