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How FDA Will Use Its New Authority against Denying, Limiting or Refusing Inspections – And Why Industry is Still Worried

 
• By Bowman Cox

How will FDA use its recently drafted guidance against obstructing inspections? Industry fears it may depend on how individual investigators interpret terms like “reasonable.”

A question raised in the packed Sept. 16 conference session spoke to everyone’s fears about overzealous investigators and how they might use FDA’s new authority to deem product adulterated whenever they believe someone is obstructing their inspection.

Recent warning letters suggest that only extreme cases will trigger FDA’s use of this powerful authority granted by section 707 of last year’s FDA Safety and Innovation Act.

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