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GUIDANCE DOCUMENT

Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection (December 2022) Draft Guidance for Industry December 2022

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2013-D-0710
Issued by:
Guidance Issuing Office
Office of Regulatory Affairs
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research
Center for Veterinary Medicine

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled, “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection.”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  This draft guidance describes, for both drugs and now devices, the types of behaviors (actions, inactions, and circumstances) that the FDA considers to constitute delaying,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.  Once finalized, this draft guidance is intended to supersede the October 2014 FDA final guidance for industry entitled, “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.” However, until this draft guidance is finalized, the October 2014 FDA guidance remains in effect until it is withdrawn and will continue to reflect FDA’s current thinking on this issue.  FDA is particularly interested in comments on the inclusion of devices to the October 2014 guidance.

Current Version: 
Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection 

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2013-D-0710.

 
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