Did You Know?
Do you know the dos and don'ts of FDA inspections?
Apr 12, 2011 | Free Downloads | |
This article was originally published by EduQuest in the March 2011 issue of EduQuest-ions & Answers.
When FDA investigators are at your site, follow these suggestions from the EduQuest staff, several of whom are former FDA 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 questions or concerns contact Martin Browning at EduQuest.