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FDA conducts inspections to determine if investigators are in compliance with FDA regulations. Inspections can be announced or unannounced.Before the Site Inspection, Identify Records FDA are Likely to Audit (See Appendix I) a. Identify all subjects, enrollment/screening log, and ALL Informed Food and Drug Administration (FDA) Site Inspection Guide The Human Subjects Office created this document to assist Principal Investigators (PI) and research This document provides guidance to the FDA field staff on a new inspectional process that may be used to assess a medical device. FDA Guide to Inspections of Quality Systems Content: This document provides guidance to the FDA field staff on a new inspectional process that may be used to So on your part, make sure you ask the inspector to clarify. Be honest in answering questions. Take corrective actions if possible, commit only to what can be