FDA Inspections

Upon notification from the FDA that an inspection will be initiated:

Obtain the following information:

  • Starting date and expected duration
  • FDA Inspector name and contact information
  • Investigator and research study that will be inspected
  • Reason for the inspection (most will be "routine")
  • Requests for specific personnel or specific documents.

Promptly notify:

  • Principal Investigator (PI)/Research Coordinator
  • Sponsor
  • The Office of Research Integrity and Compliance (ORIC) at ORIC Emory.
  • Notify us immediately if:
    • The reason for the inspection is "directed" (i.e., for cause), or
    • An FDA Inspector arrives at your site unannounced.
  • ORIC encourages the study team to arrange a discussion with the PI and ORIC to review the FDA inspection process

Checklists to help you prepare: