Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection

15 December 2022 – the FDA published the draft guidance for industry on circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection.

This draft guidance describes the types of behaviors (actions, inactions, and circumstances) that the FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection to include both drugs and devices.

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