FDA Draft Guidance Summarized: Delaying, Denying, Limiting, or Refusing a Drug Inspection

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Updated November 4, 2020

Some the links broke in the original post below.

You might also be interested in:

FDA Issues Draft Guidance on Definition of Denying, Delaying, Limiting or Refusing to Permit Inspection - The National Law Review

Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection - FDA.gov (PDF)

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Facility Inspection Guidance Issued by FDA: Delaying, Denying, Limiting, or Refusing a Drug Inspection - FDA Lawyers Blog:

" . . . in particular Section 707 of FDASIA, which added 501(j) to the FD&C Act, the FDA now deems as 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". (emphasis added)"

Read the draft guidance:
FDA - Draft Guidance for Industry - Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (PDF)

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