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
- 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: