FDA Taking Comments Regarding PGx Guidance Document

Did You Know?

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.