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.
Working With Aggressive Investigators
Published on January 29, 2016
Categorized as Submissions
Lions and tigers and bears oh my
The information on our site is not intended to provide specific legal advice.