22 Mar

Webinar - FDA Off-Label Promotion Guidelines

Answered by- David Lim

It is very interesting that some professionals use for FDA investigators in their response to FDA 483 or Warning Letter. FDA Investigator – When you receive or look at 483 the FDA personnel sign at the bottom of the 483 as FDA Investigator. The one who come and knock on the door for Inspection purposes will be FDA Investigator, but then the FDA Inspector’s duties and activities is completely different, compared to the Investigator. 

Someone who came to Inspect should be considered as FDA Inspector, but the difference is FDA Inspector is the professional who comes to your facility to collect the evidence for prosecution purposes.

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