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# Inspection Delay, Denial, Limit, Refusal Guidance
- URL: https://www.fdaweb.com/inspection-delay-denial-limit-refusal-guidance/
- Published: 2024-06-20T12:00:00.000Z
- Updated: 2026-09-14T14:33:49.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5157216

FDA has published a guidance, *Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection*, meeting a requirement for such a guidance in the 2012 FDA Safety and Innovation Act. The [document](https://www.fda.gov/media/86328/download?ref=fdaweb.com) finalizes a 12/16/2022 draft guidance and supersedes a 10/2014 guidance, which is withdrawn.

The guidance covers facilities that are subject to drug or medical device inspections under section 704 of the Federal Food, Drug, and Cosmetic Act. It 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. “The examples used in this guidance are not intended to serve as an exclusive list; rather, they illustrate the most common situations that FDA has encouraged in preparing for and conducting drug or device inspections as well as situations that FDA anticipates may occur,” the guidance says.

FDA says it does not interpret the terms delay, deny, limit, or refuse necessarily to be mutually exclusive. Thus, it says, the behaviors described in the guidance scenarios may be examples of more than one type of prohibited behavior.