FDA Guidance for Industry

Circumstances that Constitute Delaying, FDA Inspection-BlueDenying, Limiting, or Refusing a Drug Inspection

October 2014

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 adds 501(j) to the 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 requires the Food and Drug Administration (FDA) to issue guidance that defines the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection, for purposes of section 501(j).

This guidance covers facilities that are subject to inspection under section 704 of the FD&C Act. This guidance defines the types of actions, inaction, and circumstances that the FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of section 501(j). 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 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).

Section 704 of the FD&C Act authorizes FDA to conduct inspections at reasonable times, within reasonable limits, and in a reasonable manner. Although the FD&C Act does not specifically define “reasonable,” FDA has long maintained that the inspectional authority under Section 704 of the FD&C Act “extends to what is reasonably necessary to achieve the objective of the inspection.”

FDA intends to work with facilities to conduct inspections and procure the information necessary to achieve the objective of the inspection. FDA will consider reasonable explanations for behavior that may otherwise be considered to be delaying, denying, limiting, or refusing an inspection.

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FDA Pre-Announcements

In the case of drug inspections, if efforts to schedule a pre-announced inspection are met with unreasonable delays by the establishment, including requesting a later start date without a reasonable explanation, it may constitute a delay of an inspection under section 501(j) of the FD&C Act [21 U.S.C. 351(j)].

FDA will make reasonable accommodations for local conditions such as weather, holidays, or, where appropriate, manufacturing campaign schedules. However, if faced with an unreasonable delay by the establishment, you may call the responsible person’s attention to 501(j) of the Act. Talk with your supervisor to determine whether the length of a particular delay may be considered unreasonable, even in cases in which the explanation given for the delay may be reasonable.

FDA Inspection Refusal

In the case of drug inspections, inspection refusals, as well as delaying, denying, or limiting your ability to conduct the inspection, may cause a drug to be deemed adulterated under Section 501(j) of the FD&C Act [21 U.S.C. 351(j)].

  • See subsection 5.5.5.8 in Subchapter 5.5 (Drugs) for further guidance on responding to these situations.

Refusal of FDA Entry

In the case of drug inspections, if the person refuses entry or delays, denies, or limits your ability to conduct the inspection, also call the person’s attention to Section 501(j) of the FD&C Act [21 U.S.C. 351(j)] (an adulterated drug could lead to further prohibited acts under 301(a), (b), (c) [21 U.S.C. 331(a), (b), (c)]).

  • See subsection 5.5.5.8 in Subchapter 5.5 (Drugs) for further guidance on responding to these situations.

Refusal to Permit Access to or Copying of Records

In the case of drug inspections, if management refuses access to or copying of any record to which you are entitled under law, in addition to Section 301(e) noted above, call attention to Section 501(j) of the FD&C Act [21 U.S.C. 351(j)] (an adulterated drug could lead to prohibited acts under 301(a), (b), (c) [21 U.S.C. 331(a), (b), (c)]).

Furthermore, if during a drug inspection management delays producing records you request to which you are entitled under law, without giving a reasonable explanation such as requiring sufficient time to compile a large volume of records or translate the records into English, you may call their attention to 501(j) of the FD&C Act. Similarly, if management limits your access to or ability to copy any record to which you are entitled under law, you may call their attention to Section 501(j) of the FD&C Act. See subsection 5.5.5.8 in Subchapter 5.5 (Drugs) for further guidance on responding to these situations.

INSPECTION WARRANT

A refusal to permit inspection or a refusal to permit access to or copying of records may invoke criminal provisions of sections 301(e) and 301(f) of the FD&C Act [21 U.S.C. 331(e), (f)]. Furthermore, in the case of drug inspections, delaying, denying, limiting, or refusing an inspection may invoke criminal provisions of sections 301(e) and 301(f) [21 U.S.C. 331(e), (f)].

Depending on the individual situation, instances of refusal may be met by judicious use of inspection warrants.

Download IOM Chapter 5.2 – Inspection Procedures

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Last Updated: 2016-06-06

Refusing, Delaying, Denying and Limiting FDA Inspection
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