Working With Aggressive Investigators

Published on January 29, 2016
Categorized as Submissions

Lions and tigers and bears oh my

We helped a client prepare for and work with a difficult FDA investigator who did not stick to a strict routine audit, but ventured into the promotional arena as well an excursion into a quasi-BIMO inspection of their clinical trial.  We were able to get the Agency to admit it was a “for cause” and not a routine inspection.  We were able to gain from the local District Director and Center compliance staff better clarity for the inspection, a restriction of scope, and better direction for the current audit and future audits resulting in a stronger relationship with FDA post-inspection.

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Helping clients be appropriately aggressive, yet compliant. TM