Before the Site Inspection

Last revised: 
  • Complete the FDA Pre-Inspection Checklist and identify records the FDA is likely to audit.
  • Identify all subjects, enrollment/screening log, and ALL Informed Consents.
  • Selected Case Report Forms and all supportive source documentation.
  • Sequester these records and your reviews in readiness for easy access, but do not volunteer a list of them to the inspector. Always wait for a specific request to provide information.
  • If necessary, schedule a room for your inspection.

Inspector Arrival

Please also refer to your department policy for FDA site inspections.

  • There may be times when persons at other institutions (e.g., department directors at SFVA, SFGH, CRCs) should be notified that the FDA is conducting an inspection in the building.
  • Where a sign in log is used: if the inspector will not sign in, make a note in the sign in log of the name, date/time, purpose and escort name. See Appendix A on FDA Inspection Checklist.
  • The escort will walk the inspector to an appropriate meeting room. The inspector will present his/her credentials to verify that they are in order; do not expect the investigator to permit a copy to be made of the badge/credentials. 
  • The inspector will then present a Notice of Inspection (Form 482) to the Principal Investigator, this notice authorizes the inspection and its presentation officially begins the inspection. 
  • The inspector will explain the intended purpose and scope of the inspection, then ask the PI to summarize the study.