When FDA is at your site, follow these suggestions for managing FDA inspections — offered by the EduQuest staff, many of whom are former FDA expert field investigators:
- Have a defined location for investigators to work.
- Always accompany them through your facility.
- Don’t walk them through office areas unless specifically requested.
- Review each document before providing it to investigators.
- Don’t be afraid to say “I don’t know”. If you don’t know the answer, get the appropriate technical person to respond.
- Don’t guess, don’t ramble on, don’t lie or mislead.
- Don’t disagree with your own people in front of investigators. Have those discussions outside the room.
- Don’t argue with investigators. Explain your position and provide documented evidence to support it.
- Clean off white boards in advance of the inspection.
- Remove quality, regulatory or technical data from bulletin boards.
- Keep a list of all requests from investigators, including documents reviewed and those handed over.
- If investigators don’t ask for a document you believe best demonstrates your compliance, offer to provide it.
- If they ask for a document you believe they are not entitled to, explain why. Record their request and the reason you declined in your 483 response letter.
- If investigators don’t offer to provide a daily briefing of their findings or progress to date, ask for one.
For more information on preparing for and managing FDA inspections, attend EduQuest’s 3-day training class, FDA Auditing of Computerized Systems and Part 11/Annex 11 Compliance.