Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection

Docket Number: FDA-2013-D-0710 Issued by:

Guidance Issuing Office

Office of Regulatory Affairs

Center for Drug Evaluation and Research

Center for Biologics Evaluation and Research

Center for Veterinary Medicine

Center for Devices and Radiological Health

On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-144) was signed into law. Section 707 of FDASIA added section 501(j) to the Federal 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.” Section 707(b) of FDASIA required the Food and Drug Administration (FDA) to issue guidance that defined the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection, for purposes of section 501(j).

Subsequently, on August 18, 2017, the FDA Reauthorization Act of 2017 (FDARA) (Public Law 115-52) was signed into law. Section 702(c) of FDARA amended the scope of section 501(j) of the FD&C Act to include devices. A drug or device is “deemed to be adulterated” if the owner, operator, or agent of the factory, warehouse, or establishment at which the drug or device is manufactured, processed, packed, or held delays, denies, or limits an FDA inspection or refuses to permit entry or inspection of such factory, warehouse, or establishment.

This guidance finalizes the draft guidance of the same title issued on December 16, 2022 (87 FR 77125), and supersedes the October 2014 guidance entitled, “Circumstances that Constitute Delaying, Limiting, or Refusing a Drug Inspection”, which is withdrawn.

This guidance covers facilities that are subject to drug or device inspection under section 704 of the FD&C Act. This guidance defines 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 for the purposes of section 501(j) of the FD&C Act.2 The examples used in this guidance are not intended to serve as an exhaustive list; rather, they illustrate the most common situations that FDA has encountered in preparing for and conducting drug or device inspections as well as situations that FDA anticipates may occur. FDA does not interpret the four terms describing prohibited behavior (delay, deny, limit, refuse) necessarily to be mutually exclusive. Therefore, the behaviors described in the following scenarios may be examples of more than one type of prohibited behavior. Also note that, for purposes of this guidance, the term “facility” is intended to include all establishments, factories, and warehouses covered by section 501(j) of the FD&C Act.