How to Prove Your Case to the FDA and Have a Smooth Inspection

When faced with an inspection observation or finding you don’t agree with, what is the most constructive way to disagree with an FDA investigator? All you have to do is prove your point, but it must be backed by studies and scientific rationale, one investigator says.

“You can’t simply come to us and say we just don’t agree with you; I need to know why,” Brooke Higgins, consumer safety officer with the FDA’s Office of Regulatory Affairs, told an industry audience recently. She added that investigators are happy to have insightful good manufacturing practice discussions with drug and device manufacturers.

Higgins gave some other tips for having a smooth inspection, including:

• Make sure your subject matter experts are available. “We look at specific people for very specific answers,” she said;

• Ask the investigator for a daily wrap-up to understand their concerns. Higgins said she typically doesn’t do this on the first day; and

• If you are having trouble retrieving documents, offer an explanation. If something is going on, such as a printer or system goes down, just say so. “We are people too, and we understand that you run into glitches,” said Higgins.

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