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Rx Companies Push For Exemptions To Breadth Of FDA Inspections

Executive Summary

Sterile areas, cell therapies, and security systems are just a few of the items where industry wants FDA inspector access limited without triggering a new law that would make products in a facility deemed adulterated.

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US FDA Guidance On Interference With Inspections Needs More Detail, Attorneys Say

Agency should clarify how quickly it expects requested documents to be produced before a company is determined to have delayed an inspection, attorneys say during a FDLI meeting discussion of how a 2012 law enabling the agency to put a foreign facility on import alert for delaying, limiting, or refusing an inspection has played out.

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

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.

What Not To Do When FDA Comes Knocking

The U.S. FDA tweaks final guidance on what constitutes interference with FDA inspections to include examples of ‘reasonable’ explanations for sponsor delays; industry had requested many other changes.

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