What Not To Do When An FDA Inspector Knocks At Your Door
This article was originally published in The Rose Sheet
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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Longstanding US FDA policy explains what it means for a drug firm to “delay, deny, limit or refuse” an agency inspection. A revised draft guidance document expands the definitions to include device firms as well.
An FDA warning letter issued in August to OTC drug manufacturer Homeolab has revived discussion about companies' options when it comes to investigator photographs during facility inspections, prompting fresh insight from industry attorneys on the issue's legal underpinning and existing case law.
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.