Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection; Guidance for Industry, Revision 1; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled, "Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection." The FDA Reauthorization Act of 2017 (FDARA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) so that, as is the case with a drug, a device is deemed to be adulterated if the owner, operator, or agent of the factory, warehouse, or establishment at which the device is manufactured, processed, packed, or held delays, denies, or limits an FDA inspection. This final guidance describes, for both drugs and now devices, the types of behaviors (actions, inactions, and circumstances) that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection. This guidance finalizes the draft guidance of the same title issued on December 16, 2022, and supersedes the October 2014 final guidance entitled, "Circumstances That Constitute Delaying, Limiting, or Refusing a Drug Inspection."