Federal Register | FDA Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability

Federal Register | Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability:

"FDA is announcing the availability of a guidance for industry entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.” On July 9, 2012, FDASIA (Pub. L. 112-144) was signed into law. Section 707 of FDASIA adds 501(j) to the FD&C Act to make a drug adulterated 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.” As required by Section 707, FDA is issuing this guidance to define the types of action, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of Section 501(j) of the FD&C Act."

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Read the FDA Final Guidance:
Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (PDF - 106KB)

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