Preparing for the FDA Inspection

Overview

When a Principal Investigator (PI) is notified of an upcoming FDA inspection, follow these steps to prepare for the Inspector's arrival.

Step1

Consider Logistics.

Scheduling

  • Clear schedules (as much as possible) of key personnel (PI, CRC, the co-investigators most familiar with the study conduct)
  • Designate a point-of-contact/note-taker who can be available all day throughout the inspection
  • Plan attendees for daily debrief and recipients of daily email summaries during the inspection

Location

  • Reserve separate space for the inspector that does not include research-related documentation
  • Notify staff who work near the Inspector's designated space of the upcoming inspection dates

Step2

Perform a Document Review.

  • Verify that the study binder external site (opens in a new window) is complete
  • Strategically review study documents:
    • Reports to IRB / FDA  of protocol violations/incidents, unanticipated problems and corrective actions
    • Adverse events
    • Consent form signatures and versions
    • Delegation log
    • Drug / Device accountability logs
  • Consult the IRB / Study Sponsor / Compliance with any questions or issues you anticipate.

Use the FDA Pre-Inspection Checklist to ensure all bases are covered. 

Step3

Plan the Meeting.

  • Schedule a coordination call with Compliance, IRB, and others as needed.
  • Create a contact list for questions (study personnel, study sponsor, IRB coordinator, compliance, legal).

See: UCSF Roles and Responsibilities for FDA Inspections