Guidance for Industry

Circumstances that Constitute 

Delaying, Denying, Limiting, or 

Refusing a Drug Inspection 

U.S. Department of Health and Human Services

Food and Drug Administration

Office of Regulatory Affairs (ORA)

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

Center for Veterinary Medicine (CVM)

October 2014
Guidance for Industry

Circumstances that Constitute 

Delaying, Denying, Limiting, or 

Refusing a Drug Inspection 

Additional copies are available from:

Office of Policy and Risk Management

Office of Regulatory Affairs

Food and Drug Administration

12420 Parklawn Drive, rm. 4138

Rockville, MD 20857

Tel: 301-796-5300; Fax: 301-827-3670; E-mail: FDASIAImplementationORA@fda.hhs.gov

http://www.fda.gov/RegulatoryInformation/Guidances/ucm122044.htm. 

U.S. Department of Health and Human Services

Food and Drug Administration

Office of Regulatory Affairs (ORA)

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

Center for Veterinary Medicine (CVM)

October 2014
TABLE OF CONTENTS

I. INTRODUCTION............................................................................................................. 1

II. BACKGROUND ............................................................................................................... 2

III. DELAY OF INSPECTIONS............................................................................................ 3

A. Delay Scheduling Pre-announced Inspections............................................................................. 3

B. Delay During an Inspection........................................................................................................... 4

C. Delay Producing Records.............................................................................................................. 5

IV. DENIAL OF INSPECTION............................................................................................. 6

V. LIMITING OF INSPECTION ........................................................................................ 6

A. Limiting Access to Facilities and/or Manufacturing Processes ................................................. 6

B. Limiting Photography ................................................................................................................... 7

C. Limiting Access to or Copying of Records................................................................................... 7

D. Limiting or Preventing Collection of Samples ............................................................................ 8

VI. REFUSAL TO PERMIT ENTRY OR INSPECTION .................................................. 8
Contains Nonbinding Recommendations

1

Guidance for Industry1

Circumstances that Constitute Delaying, Denying, Limiting or 

Refusing a Drug Inspection

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It 

does not create or confer any rights for or on any person and does not operate to bind FDA or the public. 

You can use an alternative approach if the approach satisfies the requirements of the applicable statutes 

and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for 

implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate 

number listed on the title page of this guidance. 

I. INTRODUCTION 

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.2 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).3

 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 

 1 This guidance has been prepared by Office of Regulatory Affairs (ORA) in cooperation with Center for Drug 

Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Veterinary 

Medicine (CVM) at the Food and Drug Administration. 2 The guidance therefore covers facilities subject to inspection under any of the authorities in section 704 of the 

FD&C Act, even if some other authorities in that section may be limited or inapplicable. For example, it covers a 

pharmacy subject to inspection under the first sentence of section 704(a)(1) even if the third sentence of section 

704(a)(1) is not applicable because of section 704(a)(2). 

3 This guidance describes actions or inactions that may cause a drug to be adulterated under 501(j). Actions or 

inactions that cause a drug to be adulterated under 501(j) may also violate other provisions of the FD&C Act or 

other federal or state laws. Furthermore, actions or inactions for which a facility provides a reasonable explanation 

and therefore would not cause a drug to be adulterated under 501(j) may nevertheless violate other provisions of the 

FD&C Act or other federal or state laws. 
Contains Nonbinding Recommendations

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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.”4

 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.

FDA’s guidance documents, including this guidance, do not establish legally enforceable 

responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should 

be viewed only as recommendations, unless specific regulatory or statutory requirements are 

cited. The use of the word should in Agency guidances means that something is suggested or 

recommended, but not required. 

II. BACKGROUND

Section 704(a) of the FD&C Act provides FDA authority for inspections, specifically providing 

authority for duly designated officers or employees of the FDA to enter, at reasonable times, and 

inspect, at reasonable times and within reasonable limits and in a reasonable manner, facilities 

subject to regulation under the FD&C Act.5 An FDA inspection is a “careful, critical, official 

examination of a facility to determine its compliance with certain laws and regulations 

administered by the FDA.”6

 Section 706 of FDASIA amended section 704(a) of the FD&C Act 

 4 FDA, Investigations Operations Manual, Section 2.2.1.1, Authority to Enter and Inspect (2014). 5 Section 704(a) (21 U.S.C. 374(a)) authorizes “officers or employees duly designated by the Secretary, upon 

presenting appropriate credentials and a written notice to the owner, operator, or agent in charge...to enter, at 

reasonable times, any factory, warehouse, or establishment in which... drugs... are manufactured, processed, 

packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being 

used to transport or hold such... drugs... in interstate commerce; and... to inspect, at reasonable times and within 

reasonable limits and in a reasonable manner, such factory, warehouse, establishment or vehicle and all pertinent 

equipment, finished and unfinished materials, containers, and labeling therein.... In the case of any factory, 

warehouse, establishment or consulting laboratory in which prescription drugs, [and] nonprescription drugs intended 

for human use,... are manufactured, processed, packed, or held, the inspection shall extend to all things therein 

(including records, files, papers, processes, controls, and facilities) bearing on whether prescription drugs, [and] 

nonprescription drugs intended for human use... are adulterated or misbranded within the meaning of this Act....”

Courts have upheld the legality of such an inspection if it is conducted at a reasonable time, within reasonable limits 

and in a reasonable manner. See United States v. Biswell, 406 U.S. 311 (1972); United States v. Del Campo Baking 

Mfg. Company, 345 F. Supp. 1371 (D. Del. 1972); United States v. Business Builders, Inc., 353 F. Supp. 1333 

(N.D. Okla., 1973); see also FDA, Compliance Policy Guide, Section 130.100, Inspectional Authority; Refusal to 

Permit Inspection (Oct. 1, 1980). 6 FDA, Investigations Operations Manual, Section 5.1.2, Inspectional Approach (2014). Information collected by 

FDA during an inspection may contain trade secrets, confidential commercial or financial information, personal 

information, or other information that is exempt from public disclosure under the Freedom of Information Act, 5 
Contains Nonbinding Recommendations

3

by adding 704(a)(4), which allows FDA to request, in advance of or in lieu of an inspection, 

within a reasonable timeframe, within reasonable limits, and in a reasonable manner, records or 

information that FDA may inspect under section 704(a).

Facilities that are required to register under section 510 of the FD&C Act7 and that voluntarily 

register as outsourcing facilities under section 503B of the FD&C Act8 are required to submit 

certain information to FDA. FDA uses registration information for many purposes, including 

scheduling inspections. It is imperative that drug facilities register under section 510 when 

required, and that all registered facilities provide the information required by statute and our 

regulations to avoid creating confusion or complicating the scheduling and conduct of 

inspections. We also strongly encourage facilities to update point of contact e-mail information 

submitted to the Agency promptly if a change occurs after an annual registration submission.9

It is a prohibited act under sections 301(e) and 301(f) of the FD&C Act to refuse to permit entry 

or inspection or refuse to permit access to or copying of certain specified records.10 New section 

501(j) of the FD&C Act, as added by FDASIA section 707, now deems a drug to be adulterated 

if “...it 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.” 

III. DELAY OF INSPECTIONS

Delays may occur for many reasons, some of which are beyond the control of the facility. 

However, where an owner, operator, or agent causes the delay of an inspection, this may cause 

the drugs to be adulterated under section 501(j) of the FD&C Act. 

A. Delay Scheduling Pre-announced Inspections 

The FD&C Act does not require FDA to pre-announce its inspections. Therefore, FDA usually 

does not pre-announce for-cause and routine surveillance inspections. It is, however, FDA’s

 U.S.C. 553, or is protected from disclosure by other federal laws. See, e.g., 21 U.S.C. 331(j), 18 U.S.C. 1905; see 

also 45 C.F.R. 5.65, 21 C.F.R. 20.61. 7 See also 21 C.F.R. 207. For additional information, see Guidance for Industry, Providing Regulatory Submissions 

in Electronic Format – Drug Establishment Registration and Drug Listing. 8 In December 2013, FDA issued draft Guidance for Industry, Registration for Human Drug Compounding 

Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act. 9 Some facilities subject to inspection under section 704 of the FD&C Act, such as compounding pharmacies, may 

not be required to register under section 510 because they fall within an exception in section 510(g) and may not 

have elected to register as outsourcing facilities. Such facilities are not required to provide a point of contact e-mail 

address to FDA, but the Agency may refer to a point of contact designated in a state license in preparing for 

inspections or for other purposes, and we therefore encourage such firms to ensure that any point of contact provided 

in a state license is valid.

10 Section 301 (21 U.S.C. 331) provides in pertinent part: “The following acts and the causing thereof are hereby 

prohibited: ... (e) The refusal to permit access to or copying of any record as required by section... 704(a) .... (f) 

The refusal to permit entry or inspection as authorized by section 704.” Section 303 (21 U.S.C 333) provides 

penalties for violations of Section 301.
Contains Nonbinding Recommendations

4

general practice to contact the firm before an investigator arrives at the inspection site for preapproval and pre-license inspections, and most inspections of foreign facilities of drug products. 

This pre-announcement, although not required, is intended to facilitate the inspection process and 

ensure that appropriate records and personnel will be made available.

FDA’s efforts to schedule pre-announced inspections include sending correspondence to the 

facility’s point of contact e-mail address, including the facility’s U.S. agent if the facility is a 

foreign facility. FDA will make reasonable accommodations for local conditions, such as 

weather or security situations, holidays, and other non-work days, and, where appropriate,

scheduled manufacturing campaigns. Examples of delay in scheduling a pre-announced 

inspection that may cause drugs to be adulterated under section 501(j) of the FD&C Act include, 

but are not limited to: 

• A facility will not agree to a proposed inspection start date and does not give a reasonable 

explanation for its failure to do so.

• After scheduling an inspection, a facility requests a later start date without giving a 

reasonable explanation.

• A facility fails to respond following FDA’s attempt to contact the facility’s designated 

contact(s).

An example of a potentially reasonable explanation that might result in the drugs not being

deemed adulterated under section 501(j) of the FD&C Act includes, but is not limited to: 

• Manufacturing at the facility is not on-going, for example running only one

manufacturing campaign per month and the facility requests a different date than that 

proposed by or agreed to by FDA so that manufacturing will occur during the FDA 

inspection of the facility.

B. Delay During an Inspection 

An FDA inspection is intended to enable the Agency to review a facility’s compliance with 

certain laws and regulations. In a drug facility, FDA has broad authority to inspect things that 

bear on whether the drugs are adulterated, misbranded, or are otherwise in violation of the 

FD&C Act. Actions by a facility’s owner, operator, or agent before or after the beginning of an 

inspection that impede an FDA investigator at the inspection site from performing the inspection 

in a reasonable manner may be considered delaying the inspection. FDA is aware that its 

appearance on-site may initially cause some minor confusion and/or inconveniences to the 

facility’s employees. Minor delays that result from good faith efforts by the facility to comply 

with FDA requests generally would not be considered unreasonable. Examples of delays during 

an inspection that may cause drugs to be adulterated under section 501(j) of the FD&C Act 

include, but are not limited to: 

• A facility does not allow the FDA investigator access to an area of the facility until a 

specific future date or time even though the area is operational and is an area of the 

inspection site that FDA has authority to inspect, without giving a reasonable 

explanation.
Contains Nonbinding Recommendations

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• A facility leaves the FDA investigator in a conference room without access to necessary 

documentation or responsible individuals for an unreasonable period of time that 

interferes with the investigator’s ability to complete the inspection.

An example of a potentially reasonable explanation that might result in the drugs not being

deemed adulterated under section 501(j) of the FD&C Act includes, but is not limited to: 

• A facility does not provide the FDA investigator access to aseptic processing areas until 

the investigator accommodates the facility’s documented gowning procedures.

C. Delay Producing Records

A critical aspect of FDA’s preparation for inspection and inspection of drug facilities is the 

review and collection of hardcopy and electronic records, files, and papers bearing on whether 

the drugs are adulterated, misbranded, or are otherwise in violation of the FD&C Act. For 

example, records may be reviewed to verify compliance, but may also need to be collected to 

document evidence of deviations, interstate commerce, product labeling and promotion, and to 

identify the party or parties responsible for a variety of actions. Although FDA recognizes that 

facilities require a reasonable amount of time to produce records requested, especially if the 

records are maintained at a different site, a delay in producing records to FDA without 

reasonable explanation may be considered delaying the inspection. Examples of delays in 

producing records that may cause drugs to be adulterated under section 501(j) of the FD&C Act 

include, but are not limited to:

• During an inspection, the FDA investigator requests, within a specific, reasonable 

timeframe, records that FDA has authority to inspect, but the facility fails to produce the 

requested records within the timeframe requested by FDA, without reasonable

explanation. 

• FDA requests records pursuant to section 704(a)(4) of the FD&C Act, but the facility 

fails to produce the requested records in a timely manner, without reasonable explanation. 

Examples of potentially reasonable explanations that might result in the drugs not being deemed 

adulterated under section 501(j) of the FD&C Act include, but are not limited to: 

• The FDA investigator requests translation of the records into English, and the translation 

is not readily available. 

• The records requested are not available at that time because they are being used for a 

manufacturing operation that is in progress. 

• The volume of the records requested is sufficiently large as to require reasonable time to 

compile.

 

In instances where the facility provides a reasonable explanation for delaying production of 

records, the facility should also ensure that the resulting delay is of a reasonable duration. 
Contains Nonbinding Recommendations

6

IV. DENIAL OF INSPECTION

FDA interprets the word deny to include active behavior by the owner, operator, or agent of a 

drug facility to prevent an authorized representative of the FDA from conducting an inspection 

or to prevent FDA from completing an inspection. This includes statements or physical actions 

intended to avoid inspection or to mislead, deceive, or impede the investigator. Examples of 

behavior that may constitute a denial that may cause drugs to be adulterated under section 501(j) 

of the FD&C Act include, but are not limited to:

• A facility rejects FDA’s attempt to schedule a pre-announced inspection. 

• Upon arrival at the facility, the facility does not allow the FDA investigator to begin the 

inspection.

• A facility does not allow the FDA investigator to inspect the facility because certain staff 

members are not present, without a reasonable explanation. 

• A facility does not allow the FDA investigator to inspect the facility by falsely alleging 

the facility does not manufacture, process, pack, or hold drugs. 

• A facility sends staff home for the day and tells the FDA investigator that the facility is 

not producing any product. 

Examples of potentially reasonable explanations that might result in the drugs not being deemed 

adulterated under section 501(j) of the FD&C Act include, but are not limited to: 

• At the beginning of an unannounced inspection, appropriate personnel are not 

immediately available to accurately answer the FDA investigator’s questions. 

• The FDA investigator arrives for an unannounced inspection, but the facility is closed

due to scheduled maintenance. 

V. LIMITING OF INSPECTION

An owner, operator, or agent of a drug facility who prevents an authorized representative of the 

FDA from conducting an inspection to the extent allowable under the law may be viewed as 

limiting inspection under section 501(j). Below are examples of behavior that FDA considers to 

constitute a limitation that may cause drugs to be adulterated under section 501(j) of the FD&C 

Act. 

A. Limiting Access to Facilities and/or Manufacturing Processes

Preventing an authorized representative of the FDA reasonable access to an area of the site that 

FDA is entitled to inspect may be considered limiting the inspection. This includes the refusal to 

disclose or permit observation of the manufacturing processes. Examples include, but are not 

limited to:

• A facility orders the discontinuation of all manufacturing for the duration of the FDA 

inspection without a reasonable explanation. 
Contains Nonbinding Recommendations

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• A facility states that direct observation of the manufacturing process, in whole or in part, 

must be limited to an unreasonably short amount of time, thus preventing FDA from 

inspecting the facility as is usual and customary.

• A facility limits direct observation of portions of the manufacturing process without 

reasonable explanation.

• A facility unreasonably restricts entry to a particular portion of the facility without 

reasonable explanation. 

• Staff at a facility causes the FDA investigator to leave the premises before the inspection 

is completed. 

Examples of potentially reasonable explanations that might result in the drugs not being deemed 

adulterated under section 501(j) of the FD&C Act include, but are not limited to: 

• A facility does not provide the FDA investigator access to aseptic processing areas until 

the investigator accommodates the facility’s documented gowning procedures.

• Training specified by the Occupational Safety and Health Administration is required 

before an individual may enter a particular area of the facility, and the FDA investigator 

has not completed such training.

B. Limiting Photography

Photographs are an integral part of an FDA inspection because they present an objective and 

contemporaneous representation of facility conditions. Examples of conditions or practices 

effectively documented by photographs include, but are not limited to: evidence of rodents or 

insect infestation; faulty construction or maintenance of equipment or facilities; product storage 

conditions; product labels and labeling; and, visible contamination of raw materials or finished 

products. Impeding or resisting photography by an FDA investigator may be considered a 

limitation if such photographs are determined by the investigator to be necessary to effectively 

conduct that particular inspection. 

An example of a potentially reasonable explanation that might result in the drugs not being 

deemed adulterated under section 501(j) of the FD&C Act includes, but is not limited to: 

• The chemical properties of products manufactured at the facility are such that taking 

photographs would adversely affect product quality. 

C. Limiting Access to or Copying of Records

As explained in section III.C, the ability to access and copy records is a critical aspect of FDA 

inspections. Not allowing an authorized representative of the FDA access to or copying of 

records that FDA is entitled to inspect by law, including not providing records that FDA requests 

pursuant to section 704(a)(4) of the FD&C Act, may be considered limiting an inspection. 

Examples of records limitations include, but are not limited to: 

• A facility refuses to allow the FDA investigator to review the facility’s shipping records

that FDA has authority to inspect.
Contains Nonbinding Recommendations

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• A facility provides some, but not all of, the records requested by the FDA investigator

that FDA has authority to inspect. 

• A facility provides the FDA investigator the requested records that FDA has authority to 

inspect, but they are unreasonably redacted.11

• A facility refuses to provide records that FDA requests pursuant to section 704(a)(4), or 

such records are unreasonably redacted.

D. Limiting or Preventing Collection of Samples

Collecting samples is a critical part of FDA’s inspectional and regulatory activities. Section 

702(a) of the FD&C Act gives FDA authority to conduct investigations and collect samples. 

Preventing an authorized representative of the FDA from collecting statutorily authorized 

samples may be considered limiting the inspection. Examples of sample limitations include, but 

are not limited to, declining to allow or impeding FDA to collect the following types of samples: 

environmental samples, finished product samples, raw material samples, in-process material 

samples, and reserve samples in bioequivalence and bioanalytical studies.

VI. REFUSAL TO PERMIT ENTRY OR INSPECTION

FDA interprets the term “refuses to permit entry or inspection” to include not only active, but 

also passive behavior and non-action by the owner, operator, or agent of a drug facility that 

results in an authorized representative of the FDA not being able to enter or fully inspect the 

facility. For purposes of this guidance, such an owner, operator, or agent shall be considered to 

have refused to permit entry or inspection if such owner, operator, or agent fails to take steps to 

permit an inspection of a factory, warehouse, or other facility. Examples include, but are not 

limited to:

• Without reasonable explanation, the facility bars the FDA investigator from entering the 

facility or certain areas of the facility by, for example, not unlocking the areas or taking 

other necessary actions that would permit access by the investigator.

• Following FDA’s attempt to contact the facility’s designated contact(s) to schedule an 

inspection, the facility fails to respond. 

• The facility does not answer calls from the FDA investigator who is present at the 

facility, despite clear evidence of the presence of employees engaged in job-related 

functions. 

 11 An unreasonable redaction is one that removes or obscures information that FDA is entitled to inspect. If the 

redaction obscures information over which FDA has no inspectional authority it generally will be considered 

reasonable. Section 704(a)(1) (21 U.S.C. 374(a)(1) states that FDA’s inspectional authority does not extend to the 

following types of records: “financial data, sales data other than shipment data, pricing data, personnel data (other 

than data as to qualification of technical and professional personnel performing functions subject to this chapter), 

and research data (other than data relating to new drugs, antibiotic drugs, devices, and tobacco products and subject 

to reporting and inspection under regulations lawfully issued pursuant to section 355 (i) or (k) of this title, section

360i of this title, section 360j(g) of this title, or subchapter IX and data relating to other drugs, devices, or tobacco 

products which in the case of a new drug would be subject to reporting or inspection under lawful regulations issued 

pursuant to section 355(j) of this title).”