20 Things Never to Say to an FDA Investigator or Regulatory Auditor

This article contains the Instructions and Tips that should 20 Things Never to Say to an FDA Investigator 🚨

1. “I think…”

2. “I am not sure but [insert guess here]…”

3. “I told them not to do it this way…”

4. “You are wrong about this…you don’t know what you are talking about…”

5. “During the last inspection, the FDA investigator saw the same thing and didn’t put it on the 483…”

6. “The last investigator was crazy” or “The last investigator didn’t know what they were doing…”

7. “Well then how would you recommend we fix this deficiency?”

8. “That is the way we have always done it…”

9. “I probably shouldn’t say this, but….”

10. “If we followed those procedures, we would never get anything done.”

11. “We don’t have enough people or time to review all those complaints…”

12. “The management of this firm is only concerned with profits and does not take quality seriously.”

13. “I do it this way because our procedure does not make any sense.”

14. “I will change the procedure right away.”

15. “If you think that’s bad, you should see this…”

16. “We fixed the problem by firing the person.”

17. “That’s not my fault. It was the previous person who did that…”

18. “That’s not my problem, that is quality assurance’s problem.”

19. “Write it on the 483 – that is the only way we will correct it.”

[Side Note on #19: As an Investigator I was always surprised when the firm officials would ask me to do this – and it happened more times than you would think!!!

20. “Are you going to shut us down” or “Are we going to get a Warning Letter?”