Guidance for Industry 
Circumstances that Constitute 
Delaying, Denying, Limiting, or 
Refusing a Drug or Device 
Inspection 
 
DRAFT GUIDANCE 
 
This guidance document is being distributed for comment purposes only.  
 
Comments and suggestions regarding this draft document should be submitted within 60 days of 
publication in the Federal Register of the notice announcing the availability of the draft guidance. 
Submit electronic comments to https://www.regulations.gov. Submit written comments to the 
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. All comments should be identified with the docket number listed in 
the notice of availability that publishes in the Federal Register. 
 
 
 
 
 
 
 
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) 
Center for Devices and Radiological Health (CDRH) 
 
 
 December 2022 
Revision 1 
 
 
   
Guidance for Industry 
Circumstances that Constitute 
Delaying, Denying, Limiting, or 
Refusing a Drug or Device 
Inspection 
DRAFT GUIDANCE 
Additional copies are available from: 
 
Office of Strategic Planning and Operational Policy  
Office of Regulatory Affairs 
Food and Drug Administration  
12420 Parklawn Drive, Element Building 
Rockville, MD  20857 
E-mail: ORAPolicyStaffs@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) 
Center for Devices and Radiological Health (CDRH) 
 
December 2022 
 
   
TABLE OF CONTENTS 
 
 
I.  INTRODUCTION ................................................................................................................. 4 
II.  BACKGROUND ................................................................................................................... 5 
III.  DELAY OF INSPECTIONS .................................................................................................. 7 
A.  Delay Scheduling Pre-announced Inspections .................................................................... 7 
B.  Delay During an Inspection ................................................................................................ 8 
C.  Delay Producing Records ................................................................................................... 9 
IV.  DENIAL OF INSPECTION ................................................................................................ 10 
V.  LIMITING OF INSPECTION ............................................................................................. 10 
A.  Limiting Access to Facilities and/or Manufacturing Processes ........................................ 10 
B.  Limiting Photography ....................................................................................................... 11 
C.  Limiting Access to or Copying of Records ....................................................................... 12 
D.  Limiting or Preventing Collection of Samples ................................................................. 12 
VI.  REFUSAL TO PERMIT ENTRY OR INSPECTION ......................................................... 12 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  Contains Nonbinding Recommendations 
DRAFT  Not for Implementation 
Guidance for Industry
1 
Circumstances that Constitute Delaying, Denying, 
2 
Limiting, or Refusing a Drug or Device Inspection 
3 
4 
5  This Draft Guidance, when finalized will represent the current thinking of the Food 
6 
and Drug Administration (FDA or Agency) on this topic. It does not establish any 
7 
8  rights for any person and is not binding on FDA or the public. You can use an 
9 
alternative approach if it satisfies the requirements of the applicable statutes and 
10 
11  regulations. To discuss an alternative approach, contact the FDA staff responsible 
12 
for this guidance as listed on the title page.
13 
14 
15 
16  I.  INTRODUCTION
17 
18  On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public 
19  Law 112-144) was signed into law.  Section 707 of FDASIA added section 501(j) to the Federal 
20  Food, Drug, and Cosmetic Act (FD&C Act) to deem adulterated a drug that has been 
21  manufactured, processed, packed, or held in any factory, warehouse, or establishment and the 
22  owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an 
23  inspection, or refuses to permit entry or inspection. Section 707(b) of FDASIA required the Food 
24  and Drug Administration (FDA) to issue guidance that defined the circumstances that would 
25  constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection, for 
26  purposes of section 501(j). 
27 
28  Subsequently, on August 18, 2017, the FDA Reauthorization Act of 2017 (FDARA) (Public 
29  Law 115-52) was signed into law.  Section 702(c) of FDARA amended the scope of section 
30  501(j) of the FD&C Act to include devices. A drug or device is deemed to be adulterated if 
31  the owner, operator, or agent of the factory, warehouse, or establishment at which the drug or 
32  device is manufactured, processed, packed, or held delays, denies, or limits an FDA inspection 
33  or refuses to permit entry or inspection of such factory, warehouse, or establishment. 
34 
35  Once finalized, this draft guidance is intended to supersede the October 2014 FDA final guidance 
36  for industry entitled, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a 
37  Drug Inspection. However, until this draft guidance is finalized, the October 2014 FDA guidance 
38  remains in effect until it is withdrawn and will continue to reflect FDAs current thinking on this 
39  issue.   
40 
41 
42  This guidance covers facilities that are subject to inspection under section 704 of the FD&C Act.1
43  This guidance defines the types of behaviors (actions, inactions, and circumstances) that FDA 
1 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 
4  Contains Nonbinding Recommendations 
DRAFT  Not for Implementation 
 
 
44  considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or 
45  inspection for the purposes of section 501(j) of the FD&C Act.2   The examples used in this 
46  guidance are not intended to serve as an exhaustive list; rather, they illustrate the most common 
47  situations that FDA has encountered in preparing for and conducting inspections as well as 
48  situations that FDA anticipates may occur.  FDA does not interpret the four terms describing 
49  prohibited behavior (delay, deny, limit, refuse) necessarily to be mutually exclusive.  Therefore, the 
50  behaviors described in the following scenarios may be examples of more than one type of 
51  prohibited behavior. Also note that, for purposes of this guidance, the term "facility" is intended to 
52  include all establishments, factories, and warehouses covered by section 501(j). 
53   
54  Section 704 of the FD&C Act authorizes FDA to conduct inspections at reasonable times, within 
55  reasonable limits, and in a reasonable manner.  Although the FD&C Act does not specifically 
56  define reasonable, FDA has long maintained that the inspectional authority under section 704 of 
57  the FD&C Act extends to what is reasonably necessary to achieve the objective of the 
58  inspection.3  FDA intends to work with facilities to conduct inspections and procure the 
59  information necessary to achieve the objective of the inspection. FDA will consider reasonable 
60  explanations for behavior that may otherwise be considered to be delaying, denying, limiting, or 
61  refusing an inspection. 
62   
63  In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
64  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only as 
65  recommendations, unless specific regulatory or statutory requirements are cited. The use of the 
66  word should in Agency guidances means that something is suggested or recommended, but not 
67  required. 
68   
69  II.  BACKGROUND 
70   
71  Section 704(a) of the FD&C Act provides FDA authority for inspections, specifically providing 
72  authority for duly designated officers or employees of FDA to enter, at reasonable times, and 
73  inspect, at reasonable times and within reasonable limits and in a reasonable manner, facilities 
74  subject to regulation under the FD&C Act.4  An FDA inspection is a careful, critical, official 
 
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). 
2 This guidance describes actions or inactions that may cause a drug or device to be adulterated under 501(j) of the 
FD&C Act, as amended by section 702(c) of FDARA. Actions or inactions that cause a drug or device 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 or device to be adulterated under 501(j) may nevertheless violate other provisions of the FD&C Act or other 
federal or state laws. 
3 FDA, Investigations Operations Manual, Section 2.2 Statutory Authority  
4 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, [and] devices... 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, [and] devices... in interstate commerce; and... to inspect, at 
reasonable times and within  reasonable limits and in a reasonable manner, such factory, warehouse, establishment or 
 
 
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75  examination of a facility to determine its compliance with the laws and regulations administered by 
76  the FDA.5   Section 706 of FDASIA amended section 704(a) of the FD&C Act by adding 
77  704(a)(4), which allows FDA to request, in advance of or in lieu of a drug facility inspection, 
78  within a reasonable timeframe, within reasonable limits, and in a reasonable manner, records or 
79  information that FDA may inspect under section 704.  As it pertains to device inspections, section 
80  704(e) requires that FDA be permitted to inspect and copy records required to be maintained under 
81  section 519 or 520(g) of the FD&C Act. 
82   
83  Facilities that are required to register under section 510 of the FD&C Act6 and those that 
84  voluntarily register as outsourcing facilities under section 503B of the FD&C Act7 are required to 
85  submit certain information to FDA.  FDA uses registration information for many purposes, 
86  including scheduling of inspections. It is imperative that drug and device facilities register under 
87  section 510 of the FD&C Act when required, and that all registered facilities provide the 
88  information required by statute and FDA regulations to avoid creating confusion or complicating 
89  the scheduling and conduct of inspections.  We also strongly encourage facilities to update point of 
90  contact e-mail information submitted to the Agency promptly if a change occurs after an annual 
91  registration submission.8 
92   
 
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,  nonprescription 
drugs intended  for human use, [and] restricted devices... 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, nonprescription drugs intended for human use, [and] restricted devices... 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). 
5 FDA, Investigations Operations Manual, Section 5.1.2, Inspectional Approach. 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 
U.S.C. 552, 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. 
6 See also 21 C.F.R.  207, 21 C.F.R. 807.  For additional information for drug establishments, see Guidance for 
Industry, Providing Regulatory Submissions  in Electronic Format  Drug Establishment Registration and Drug Listing. 
For additional information for device establishments, see https://www.fda.gov/medical-devices/device-registration-and-
listing/how-register-and-list.  
7 See Guidance for Industry, Registration for Human Drug Compounding  Outsourcing Facilities Under Section 503B 
of the Federal Food, Drug, and Cosmetic Act. 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm  
8 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.  Information on how to update registration and listing for device firms can be found at 
https://www.fda.gov/medical-devices/device-registration-and-listing/how-register-and-list#12.  
 
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93  It is a prohibited act under sections 301(e) and 301(f) of the FD&C Act to refuse to permit entry or 
94  inspection or refuse to permit access to or copying of certain specified records.9 Section 501(j) of 
95  the FD&C Act, as amended by FDARA section 702(c), now deems a drug or device to be 
96  adulterated if it has been manufactured, processed, packed, or held in any factory, warehouse, or 
97  establishment and the owner, operator, or agent of such factory, warehouse, or establishment 
98  delays, denies, or limits an inspection, or refuses to permit entry or inspection. 
99   
100  III.  DELAY OF INSPECTIONS 
101   
102  Delays may occur for many reasons, some of which are beyond the control of the facility.  FDA 
103  will consider reasonable explanations for behavior that may otherwise be considered to be delaying, 
104  denying, limiting, or refusing an inspection. However, where an owner, operator, or agent causes 
105  the unreasonable delay of an inspection, this may cause the drugs or devices manufactured, 
106  processed, packed, or held therein to be adulterated under section 501(j) of the FD&C Act.  
107   
108  A.  Delay Scheduling Pre-announced Inspections 
109   
110  For inspections at drug facilities, the FD&C Act does not require FDA to pre-announce its 
111  inspections. Therefore, FDA usually does not pre-announce for-cause and routine surveillance drug 
112  facility inspections. It is, however, FDAs general practice to contact the firm before an 
113  investigator arrives at the inspection site for pre-approval and pre-license inspections, and most 
114  inspections of foreign facilities of drug products.  This pre-announcement, although not required, is 
115  intended to facilitate the inspection process and ensure that appropriate records and personnel will 
116  be made available. 
117   
118  For inspections at device facilities, section 704(h) of the FD&C Act, added by section 702 of 
119  FDARA, requires FDA to pre-announce inspections (other than for-cause inspections) of foreign 
120  and domestic device establishments.10  Where pre-announcement of inspections is not required, 
121  pre-announcements may be made at FDAs discretion. 
122   
123  FDAs efforts to schedule pre-announced inspections may include notification via telephone or 
124  sending correspondence to the facilitys point of contact e-mail address, including the facilitys 
125  U.S. agent if the facility is a foreign facility.  FDA will make reasonable accommodations for local 
126  conditions, such as weather or security situations, holidays, and other non-workdays, and, where 
127  appropriate, scheduled manufacturing campaigns.   
128   
129  Examples of delay in scheduling a pre-announced inspection that may cause drugs or devices to be 
130  adulterated under section 501(j) of the FD&C Act include, but are not limited to: 
131   
 
9 Section 301 of the FD&C Act (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 of the 
FD&C Act (21 U.S.C 333) provides  penalties for violations of section 301 of the FD&C Act. 
10  Section 702(b) of FDARA directed FDA to issue guidance that specifies how the Agency will implement processes 
and standards that are applicable to device inspections.  See Guidance for Industry, Review and Update of Device 
Establishment Inspection Processes and Standards, Guidance for Industry.  
 
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132    A facility will not agree to an announced inspection start date and does not give a 
133  reasonable explanation for its failure to do so. 
134    After scheduling an inspection, a facility requests a later start date without giving a 
135  reasonable explanation. 
136    A facility fails to respond following FDAs attempts to contact the facilitys 
137  designated contact(s). 
138   
139  Examples of potentially reasonable explanations for scheduling delays that might result in the drugs 
140  not being  deemed adulterated under section 501(j) of the FD&C Act include, but are not limited 
141  to: 
142   
143    Manufacturing at a drug facility is not on-going, for example running only one 
144  manufacturing campaign per month, and the facility requests a different date than 
145  that proposed by or agreed to by FDA so that manufacturing will occur during the 
146  FDA inspection of the facility. 
147   
148  B.  Delay During an Inspection 
149   
150  An FDA inspection is intended to enable the Agency to review a facilitys compliance with 
151  applicable FDA requirements.  FDA has broad authority to inspect facilities, including but not 
152  limited to the conditions and operations of a facility that bear on whether the drugs or devices are 
153  adulterated, misbranded, or are otherwise in violation of the FD&C Act.  Actions by a facilitys 
154  owner, operator, or agent before or during an inspection that impede an FDA investigator at the 
155  inspection site from performing the inspection in a reasonable manner may be considered delaying 
156  the inspection. FDA is aware that its appearance on-site may initially cause some minor confusion 
157  and/or inconvenience to the facilitys employees.  Minor delays that result from good faith efforts 
158  by the facility to comply with FDA requests generally would not be considered unreasonable.   
159   
160  Examples of delays during an inspection that may cause drugs or devices to be adulterated under 
161  section 501(j) of the FD&C Act include, but are not limited to: 
162   
163    A facility does not allow the FDA investigator access to an area of the facility until a 
164  specific future date or time even though the area is operational and is an area of the 
165  inspection site that FDA has authority to inspect, without giving a reasonable 
166  explanation. 
167    A facility leaves the FDA investigator in a conference room without access to necessary 
168  documentation or responsible individuals for an unreasonable period of time that 
169  interferes with the investigators ability to complete the inspection. 
170    A facility agrees to the pre-announced inspection date, but when the investigator enters 
171  the facility, the necessary facility personnel are not available, or the firms management 
172  informs the investigator that operations are shutdown, without providing a reasonable 
173  explanation. 
174   
175   
 
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176  An example of a potentially reasonable explanation that might result in the drugs or devices not 
177  being deemed adulterated under section 501(j) of the FD&C Act includes, but is not limited to: 
178   
179    A facility does not provide the FDA investigator access to aseptic processing areas   
180  until the investigator accommodates the facilitys documented gowning procedures. 
181   
182    A device facility does not provide FDA investigator access to environmentally 
183  controlled areas until the investigator accommodates the facilitys precautionary 
184  measures to prevent contamination and risk of personal safety.      
185   
186   
187  C.  Delay Producing Records 
188   
189  A critical aspect of FDAs preparation for inspection and inspection of drug or device facilities is 
190  the review and collection of hardcopy and electronic records, files, and papers bearing on whether 
191  the drugs or devices are adulterated, misbranded, or are otherwise in violation of the FD&C Act. 
192  For example, records may be reviewed and collected to verify compliance, interstate commerce, 
193  product labeling and promotion, and to identify responsible parties. Although FDA recognizes that 
194  facilities require a reasonable amount of time to produce records requested, especially if the records 
195  are maintained at a different site, a delay in producing records to FDA without reasonable 
196  explanation may be considered delaying the inspection.   
197   
198  Examples of delays in producing records that may cause drugs or devices to be adulterated under 
199  section 501(j) of the FD&C Act include, but are not limited to: 
200   
201    During an inspection, the FDA investigator requests, within a reasonable timeframe, 
202  records that FDA has authority to inspect, but the facility fails to produce the requested 
203  records within the timeframe requested by FDA, without reasonable explanation. 
204    FDA requests records pursuant to section 704(a)(4) or 704(e) of the FD&C Act, but the 
205  facility fails to produce the requested records in a timely manner, without reasonable 
206  explanation. 
207   
208  Examples of potentially reasonable explanations that might result in the drugs or devices not being 
209  deemed adulterated under section 501(j) of the FD&C Act include, but are not limited to: 
210   
211    The FDA investigator requests translation of the records into English, and the translation 
212  is not readily available. 
213    The records requested are not available at that time because they are being used for a 
214  manufacturing operation that is in progress, accessing the records would 
215  unnecessarily disrupt the operation, and the records are provided as soon as 
216  practicable. 
217    The volume of the records requested is sufficiently large as to require reasonable 
218  additional time to compile.  
219    The records requested are stored off-site and require reasonable additional time to 
220  collect. 
 
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221   
222  In instances where the facility provides a reasonable explanation for delaying production of 
223  records, the facility should also ensure that the resulting delay is of a reasonable duration that is 
224  agreed upon by the facility and FDA. 
225   
226  IV.  DENIAL OF INSPECTION 
227   
228  FDA interprets the word deny to include any behavior by the owner, operator, or agent of a drug 
229  or device facility to prevent an authorized representative of FDA from conducting an inspection  or 
230  to prevent FDA from completing an inspection.  This includes statements or physical actions 
231  intended to avoid inspection or to mislead, deceive, or impede the investigator.  
232   
233  Examples of  behavior that may constitute a denial that may cause drugs or devices to be 
234  adulterated under section 501(j) of the FD&C Act include, but are not limited to: 
235   
236    A facility rejects FDAs attempt to schedule a pre-announced inspection. 
237    Upon arrival at the facility, the facility does not allow the FDA investigator to begin the 
238  inspection. 
239    A facility does not allow the FDA investigator to inspect the facility because certain staff 
240  members are not present, without a reasonable explanation. 
241    A facility does not allow the FDA investigator to inspect the facility by falsely alleging 
242  the facility does not manufacture, process, pack, or hold drugs or devices. 
243    A facility sends staff home for the day and tells the FDA investigator that the facility is 
244  not producing any product. 
245   
246  Examples of potentially reasonable explanations that might result in the drugs or devices not being 
247  deemed adulterated under section 501(j) of the FD&C Act include, but are not limited to: 
248   
249    At the beginning of an unannounced inspection, appropriate personnel are not 
250  immediately available to accurately answer the FDA investigators questions. 
251    The FDA investigator arrives for an unannounced inspection, but the facility is closed 
252  due to scheduled maintenance. 
253   
254  V.  LIMITING OF INSPECTION 
255   
256  An owner, operator, or agent of a drug or device facility who prevents an authorized representative 
257  of FDA from conducting an inspection to the extent allowable under the law may be viewed as 
258  limiting inspection under section 501(j) of the FD&C Act.  Below are examples of behavior that 
259  FDA considers to  constitute a limitation that may cause drugs or devices to be adulterated under 
260  section 501(j) of the FD&C Act. 
261   
262  A.  Limiting Access to Facilities and/or Manufacturing Processes 
263   
264  Preventing an authorized representative of FDA reasonable access to an area of the site that  FDA 
265  is entitled to inspect may be considered limiting the inspection.  This includes the refusal to 
 
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266  disclose or permit observation of the manufacturing processes. Examples include, but are not 
267  limited to: 
268   
269    A facility orders the discontinuation of all manufacturing for the duration of the FDA 
270  inspection, without a reasonable explanation. 
271    The firm interrupts production activities to prevent FDA investigators from 
272  observing production operations. 
273    A facility limits FDAs direct observation of the manufacturing process, in whole or in 
274  part, to an unreasonably short amount of time, thus preventing FDA from inspecting the 
275  facility as is usual and customary. 
276    A facility limits direct observation of portions of the manufacturing process, without 
277  reasonable explanation. 
278    A facility unreasonably restricts entry to a particular portion of the facility, without 
279  reasonable explanation. 
280    Staff at a facility causes the FDA investigator to leave the premises before the inspection 
281  is completed, without reasonable explanation. 
282   
283  Examples of potentially reasonable explanations that might result in the drugs or devices not being 
284  deemed adulterated under section 501(j) of the FD&C Act include, but are not limited to: 
285   
286    A facility does not provide the FDA investigator access to aseptic processing areas until 
287  the investigator accommodates the facilitys documented gowning procedures. 
288    Training specified by the Occupational Safety and Health Administration is required 
289  before an individual may enter a particular area of the facility, and the FDA investigator 
290  has not completed such training. 
291   
292  B.  Limiting Photography 
293   
294  Photographs are an integral part of an FDA inspection because they present an objective and 
295  contemporaneous representation of facility conditions. Examples of conditions or practices 
296  effectively documented by photographs include but are not limited to: evidence of rodents or 
297  insect infestation; faulty construction or maintenance of equipment or facilities; product storage 
298  conditions; product labels and labeling; and visible contamination of components, containers, 
299  closures, or products. Impeding or resisting photography by an FDA investigator may be 
300  considered a limitation if such photographs are determined by the investigator to be necessary to 
301  effectively conduct that particular inspection. 
302   
303  An example of a potentially reasonable explanation that might result in the drugs or devices not 
304  being deemed adulterated under section 501(j) of the FD&C Act includes, but is not limited to: 
305   
306    The chemical properties of products manufactured at the facility are such that taking 
307  photographs would adversely affect product quality. 
308    The facility can document that taking photographs of any raw material or assembly 
309  would adversely affect product quality.  
310   
 
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311  C.  Limiting Access to or Copying of Records 
312   
313  As explained in section III.C., the ability to access and copy records is a critical aspect of FDA 
314  inspections. Not allowing an authorized representative of FDA access to or copying of records that 
315  FDA is entitled to inspect by law, including not providing records that FDA requests pursuant to 
316  section 704(a)(4) or 704(e) of the FD&C Act, may be considered limiting an inspection.  Examples 
317  of limiting access to records include, but are not limited to: 
318   
319    A facility refuses to allow the FDA investigator to review the facilitys shipping records 
320  that FDA has authority to inspect. 
321    A facility provides some, but not all, records requested by the FDA investigator  that 
322  FDA has authority to inspect. 
323    A facility provides the FDA investigator the requested records that FDA has authority to 
324  inspect, but they are unreasonably redacted.11 
325    A facility refuses to provide records that FDA requests pursuant to section 704(a)(4) or 
326  704(e), or such records are unreasonably redacted. 
327    A facility maintains electronic records but omits or limits the data contained in the 
328  electronic records when providing electronic copies of the records to FDA. This 
329  includes but is not limited to actions such as removing data columns in Excel, 
330  removing data from the electronic record when providing the record to FDA, exporting 
331  data into reports without including all of the data fields (unless otherwise requested by 
332  FDA), or locking the electronic worksheet so that the data cannot be searched, sorted, 
333  or analyzed by FDA.   
334    A facility identifies an electronic record as the original but does not provide an 
335  electronic copy of that record (or data query) to FDA pursuant to FDA's request.   
336   
337  D.  Limiting or Preventing Collection of Samples 
338   
339  Collecting samples is a critical part of FDAs inspectional and regulatory activities. Section 702 of 
340  the FD&C Act gives FDA authority to conduct investigations and collect samples.  Preventing an 
341  authorized representative of FDA from collecting statutorily authorized samples may be considered 
342  limiting the inspection.  Examples of sample limitations include, but are not limited to, declining to 
343  allow or impeding FDA from collecting the following types of samples:  environmental samples, 
344  finished product samples, raw material samples, in-process material samples, reserve samples in 
345  bioequivalence and bioanalytical studies, and labeling. 
346   
347  VI.  REFUSAL TO PERMIT ENTRY OR INSPECTION 
 
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) of the FD&C Act (21 U.S.C. 374(a)(1)) states that FDAs 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 qualifications of technical and professional personnel performing functions subject to this 
Act),  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 505(i) or (k), section 519, 
section 520(g), or chapter 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 505(j)). 
 
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  Contains Nonbinding Recommendations 
DRAFT  Not for Implementation 
 
 
348   
349  FDA interprets the term refuses to permit entry or inspection to include not only active, but also 
350  passive behavior and inaction by the owner, operator, or agent of a facility that results in an 
351  authorized representative of FDA not being able to enter or fully inspect the facility. For purposes 
352  of this guidance, such an owner, operator, or agent shall be considered to have refused to permit 
353  entry or inspection if such owner, operator, or agent fails to take steps to permit an inspection of a 
354  facility. Examples include, but are not limited to: 
355   
356    Without reasonable explanation, the facility bars the FDA investigator from entering the 
357  facility or certain areas of the facility by, for example, not unlocking the areas or taking 
358  other necessary actions that would permit access by the investigator. 
359    Following FDAs attempt to contact the facilitys designated contact(s) to schedule an 
360  inspection, the facility fails to respond. 
361    The facility does not answer calls from the FDA investigator, despite clear 
362  evidence of the presence of employees engaged in job-related  functions. 
363   
 
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