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
    • Emory’s Office of Compliance (OC) compliance.emory.edu
    • Notify OC immediately if:
      • The reason for the inspection is “directed” (i.e., for cause), or
      • An FDA Inspector arrives at your site unannounced.
    • OC encourages the study team to arrange a discussion with the PI and OC to review the FDA inspection process

Checklists to help you prepare: