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Respond quickly to post-inspection letters from FDA, consultant warns

This article was originally published in SRA

Executive Summary

Staying in communication with the compliance officer at US Food and Drug Administration district offices is essential when device companies receive a 483 form from the agency following an inspection. “The compliance officer is the key contact who you want to work with, and within the right timeframe, in order to avoid a warning letter,” according to Edwin Bills, principal consultant at Bilanx Consulting.

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