Compliance 360° Part 1: Handling Difficult US FDA Investigators

This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this first installment, former FDA investigations branch director Ricki Chase explains how you should handle a difficult agency investigator who shows up at your facility door.

MT1701_Compliance360

When Ricki Chase worked at US FDA, she witnessed some truly bizarre behavior from agency investigators.

“Throughout my years, I had numerous opportunities to train and to audit the investigators, and noted attitudes and behaviors that could’ve been perceived by our partners in industry as aggressive,...

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