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What Not To Do When An FDA Inspector Knocks At Your Door

This article was originally published in The Rose Sheet

Executive Summary

FDA tweaks its guidance on what constitutes interference with facility inspections to include examples of “reasonable” explanations for delays, without addressing many industry concerns raised during a comment period. Created to provide FDA’s perspective on 2012 changes to federal food and drug law related to adulterated drug products, the guidance’s “sweeping” language suggests it could have relevance for inspections of cosmetic facilities conducted by the agency, attorneys say.

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