From The Corner Lab - Blog Posts

FDA Draft Guidance Under FDASIA States That Delaying, Denying, Limiting an FDA Inspection Could Deem A Drug Misbranded or Adulterated

Posted by Jim Menoutis on Thu, Nov 07, 2013 @ 03:27 PM

On July 12, 2013 the FDA released a Draft Guidance,  Guidance for Industry Circumstances  that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection, for comment. The Draft Guidance was issued in support of the Food and Drug Administration Safety and Innovation Act (FDASIA). Under Section 707(b) of FDASIA, the FDA was required to issue  guidance that defines the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection, for purposes of section 501(j).  This is because 501(j) adds a new twist to what is deemed  an adulterated drug.  Specifically, Section 707 of FDASIA adds 501(j) to the Food, Drug, and Cosmetic Act (FD&C Act) to deem adulterated a drug that “has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.”

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Topics: Establishment Inspection, Inspection, cGMP, Drug facility Inspection, FDA, Aduterated, Misbranded, FDA Inspection