4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0710]
Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device
Inspection; Guidance for Industry, Revision 1; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
SUMMARY: 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 This guidance finalizes the draft guidance of the same title issued on December 16,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.”
DATES: The announcement of the guidance is published in the Federal Register on [INSERT
DATE OF PUBLICATION IN THE FEDERAL REGISTER].
ADDRESSES: You may submit comments on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:

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Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for
submitting comments. Comments submitted electronically, including attachments, to
https://www.regulations.gov will be posted to the docket unchanged. Because your
comment will be made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party may not wish to be
posted, such as medical information, your or anyone else’s Social Security number, or
confidential business information, such as a manufacturing process. Please note that if
you include your name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on
https://www.regulations.gov.

•

If you want to submit a comment with confidential information that you do not wish to be
made available to the public, submit the comment as a written/paper submission and in
the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions
Submit written/paper submissions as follows:
•

Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.

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For written/paper comments submitted to the Dockets Management Staff, FDA will post
your comment, as well as any attachments, except for information submitted, marked and
identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket No. FDA-2013-D-0710

for “Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device
Inspection.” Received comments will be placed in the docket and, except for those submitted as
“Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

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Confidential Submissions--To submit a comment with confidential information that you
do not wish to be made publicly available, submit your comments only as a written/paper
submission. You should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states “THIS DOCUMENT
CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy,
including the claimed confidential information, in its consideration of comments. The
second copy, which will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov. Submit
both copies to the Dockets Management Staff. If you do not wish your name and contact
information to be made publicly available, you can provide this information on the cover
sheet and not in the body of your comments and you must identify this information as
“confidential.” Any information marked as “confidential” will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA’s posting of comments to public dockets, see 80 FR 56469,
September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and

written/paper comments received, go to https://www.regulations.gov and insert the docket
number, found in brackets in the heading of this document, into the “Search” box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for a single hard copy of the guidance entitled “Circumstances
That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection” to the
Office of Policy, Compliance and Enforcement, Office of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Drive, Element Building, Rockville, MD 20857. Send one self-

addressed adhesive label to assist that office in processing your request. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Lola Burford, Office of Regulatory Affairs,
Division of Operational Policy, Food and Drug Administration, 12420 Parklawn Drive, Element
Building, Rockville, MD 20857, Lola.Burford@fda.hhs.gov, 240-402-5865.
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2012, the Food and Drug Administration Safety and Innovation Act
(FDASIA) (Pub. L. 112-144) added section 501(j) to the FD&C Act (21 U.S.C. 351(j)) 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 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). In the Federal Register of
October 22, 2014 (79 FR 63130), FDA announced the availability of a guidance for industry
entitled, “Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug
Inspection” (hereinafter, 2014 guidance).
Subsequently, on August 18, 2017, FDARA (Pub. L. 115-52) was signed into law.
Section 702 of FDARA amended the scope of section 501(j) of the FD&C Act to provide that, as
the case with drugs, devices are deemed to be adulterated if an FDA inspection is delayed,
denied, limited, or refused by the owner, operator, or agent of the establishment at which the
device is manufactured, processed, packed, or held. This final guidance supersedes the 2014
final guidance to incorporate devices and to explain the circumstances that FDA would consider
to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection,
resulting in a drug or device manufactured in the facility being deemed adulterated.

This final guidance is being issued consistent with FDA’s good guidance practices
regulation (21 CFR 10.115). FDA considered the comments received on the draft guidance and
did not make substantial changes from the draft to the final guidance. This final guidance
represents the current thinking of FDA on “Circumstances That Constitute Delaying, Denying,
Limiting, or Refusing a Drug or Device Inspection” It does not establish any rights for any
person and is not binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance contains no collection of information. Therefore, clearance by the Office
of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance at either
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/search-general-andcross-cutting-topics-guidance-documents or https://www.regulations.gov. Persons unable to
download an electronic copy of “Circumstances That Constitute Delaying, Denying, Limiting, or
Refusing a Drug or Device Inspection” may send an email request to
ORAPolicyStaffs@fda.hhs.gov to receive an electronic copy of the document.
Dated: June 17, 2024.

Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13674 Filed: 6/20/2024 8:45 am; Publication Date: 6/21/2024]