Contains Nonbinding Recommendations  
Draft  Not for Implementation  
 
 
Conducting Remote Regulatory  
1  
Assessments 
2    
Questions and Answers  
3  
Draft Guidance for Industry 
4    
5   This draft guidance document is for comment purposes only.  
6   Comments and suggestions regarding this draft document should be  submitted within 60 days of  
7   publication in the  Federal Register of  the notice announcing the  availability of the  draft  
8   guidance. Submit  electronic comments to http://www.regulations.gov. Submit written  
9   comments to the Dockets Management  Staff (HFA-305), Food and Drug Administration, 5630  
10   Fishers Lane, Room 1061, Rockville, MD 20852. All  comments  should be  identified with the  
11   docket number  FDA-2022-D-0810. 
12   For questions  or  information regarding this guidance, contact  the Office of Regulatory Affairs  
13   (ORA), Office of Policy, Compliance, and Enforcement (OPCE), Food and Drug  
14   Administration at  ORAPolicyStaffs@fda.hhs.gov.  
15   U.S. Department of  Health and Human Services  
16   Food and Drug Administration  
17   Office of Regulatory Affairs  
18   Office of Food Policy and Response   
19   Office of Combination Products  
20   Center for Biologics Evaluation  and Research  
21   Center for Drug Evaluation and Research  
22   Center  for Devices and Radiological  Health  
23   Center for Food  Safety  and Applied Nutrition  
24   Center for Tobacco Products  
25   Center for Veterinary  Medicine  
26   January 2024  
0  
  Contains Nonbinding Recommendations  
Draft   Not for Implementation  
 
 
Conducting Remote Regulatory  
27  
Assessments 
28    
Questions  and Answers  
29  
Draft  Guidance for Industry 
30    
31   This draft guidance document is for comment purposes only.  
32   Additional copies are available  from:   
33    Office of Policy, Compliance, and Enforcement,  Office of Regulatory Affairs, Food and Drug  
34   Administration 12420 Parklawn Drive, Element Building, Rockville, MD 20857  
35   U.S. Department of  Health and Human Services   
36   Food  and Drug Administration  
37   Office of Regulatory Affairs  
38   Office of Food Policy and Response   
39   Office of Combination Products  
40   Center for Biologics Evaluation  and Research  
41   Center for Drug Evaluation and Research   
42   Center  for Devices and Radiological  Health   
43   Center  for Food Safety  and Applied Nutrition  
44   Center for Tobacco Products  
45   Center for Veterinary  Medicine  
 
46   January 2024   
1  
  Contains Nonbinding Recommendations  
Draft   Not for Implementation  
 
 
Table of Contents  
47  
48   I. Introduction  .............................................................................................................................................  3  
49   II.Background  ............................................................................................................................................  4  
50  III.  Questions and Answers ........................................................................................................................  6  
51   A. Remote Regulatory Assessment Fundamentals ...................................................................................  6  
52   1. What is an RRA?  .......................................................................................................................................  6  
53   2. Who may be  subject to an RRA?  ...............................................................................................................  6  
54   3. Are RRAs  replacing other established means of obtaining information outside of inspections?  .............  7  
55  4. Is an RRA an inspection? ..........................................................................................................................  7  
56   5. When may FDA initiate  or request to conduct  an RRA?  ..........................................................................  8  
57   6. Will FDA use RRAs during or as part of an FDA inspection of an establishment?  .................................  8  
58   7. What are the benefits of  an RRA?  .............................................................................................................  9  
59   B. Remote Regulatory Assessment Expectations  .....................................................................................  9  
60  8. How may FDA request an RRA?...............................................................................................................  9  
61   9. What might an establishment expect to happen during an RRA?  ...........................................................  11  
62   10. Are  there any consequences  for declining to participate  in an RRA?  ..................................................  12  
63   11. Are  there any technological expectations for an RRA?  ........................................................................  12  
64   C. Requests for Records or Other Information as Part of Remote Regulatory  Assessments ............  13  
65  12. What records or other  information may FDA request as part of an RRA?  ..........................................  13  
66   13. For what purposes may FDA use the  records and other  information gathered during an RRA?  ........  14  
67   14. If the RRA requests records or other information,  what is the timeframe for submitting the records 
68   and other information to FDA?  ..................................................................................................................  15  
69   15. How should records or  other information in response to an RRA request be provided to FDA?  ........  15  
70  D. Completion of  a Remote Regulatory Assessment ..............................................................................  16  
71   16. What  may  occur upon completion of an RRA?  .....................................................................................  16  
2  
  Contains Nonbinding Recommendations  
Draft  Not for Implementation  
 
 
Conducting Remote  Regulatory  
72  
Assessments 
 
73  
Questions  and Answers  
74  
 
Guidance for Industry1 
75  
 
This draft guidance, when finalized, represents the current  thinking of  the  Food and Drug  
Administration (FDA or Agency) on this  topic. 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. To discuss  an  alternative approach, contact  
the FDA staff or Office responsible for this guidance as listed on  the title page.  
76    
77   I. Introduction  
78   In response to the Coronavirus Disease 2019 (COVID-19) pandemic, FDA adapted its operations for  field 
79   activities to  provide  oversight  of regulated  industry while mitigating the spread of COVID-19. One  set  of  
80   tools used during the  COVID-19 public health emergency for oversight of  FDA-regulated products  was  
81   remote regulatory assessments (RRAs).  The term RRA  (as defined in  the Question and Answers 
82   section) is used to describe a category of  activities  for which FDA may use  different terminologies,  but  
83   that are all considered to be  types  of RRAs,  including  remote interactive evaluations2 and remote 
84   record reviews.  Such activities,  along with others identified in  this  draft  guidance, are  considered RRAs  
85   for  purposes of this  guidance. In the presence of  travel  restrictions during the COVID-19 pandemic, FDA  
86   utilized RRAs to assess establishments and their compliance with  applicable FDA requirements.  Based on 
 
1  This draft  guidance  has been prepared by the Office  of Regulatory Affairs in cooperation with the Center for  
Biologics Evaluation and Research, the Center  for Drug Evaluation and Research, the Center for Food Safety and 
Applied Nutrition, the Center  for Tobacco Products, the Center for Devices and Radiological Health, the Center for  
Veterinary Medicine, the Office of Food Policy  and  Response, and the Office  of Combination Products.   
2  See  Remote Interactive Evaluations of Drug Manufacturing  and Bioresearch Monitoring Facilities,  Draft  Guidance 
for Industry,  issued  October  2023.  See  https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/remote-interactive-evaluations-drug-manufacturing-and-bioresearch-monitoring-facilities.  We update 
guidance  documents periodically. For the most recent version of a  guidance, check the FDA guidance web page at  
https://www.fda.gov/regulatory-information/search-fda-guidance-documents.   
3  
  Contains Nonbinding Recommendations  
Draft   Not for Implementation  
 
 
87   this  experience,3  FDA has  noted the value of  RRAs  and  concluded that  they should  be used for certain  
88   scenarios outside  the  COVID-19 pandemic  and for  all types of FDA-regulated products.4  FDA has  
89   developed this  guidance to provide  answers to frequently asked questions related to RRAs. When 
90   finalized, this guidance  is  intended to help enhance  industrys understanding of RRAs, thereby facilitating 
91   FDAs process for conducting RRAs.  
92   Throughout  this guidance, the terms, FDA,  the Agency, we, us,  and our  refer to the  Food and 
93   Drug Administration.  In this guidance, the term establishment  includes any facility, entity, person,  
94   importer, or  site, whether foreign or domestic, subject  to the laws administered by FDA.  
95   FDAs guidance documents, including this  draft  guidance, do not establish legally enforceable  
96   responsibilities. Instead, guidance documents describe  our current  thinking on a topic and should be  
97   viewed only as recommendations,  unless specific regulatory  or statutory  requirements are cited.  The use 
98   of the word should  in Agency guidance means that  something is suggested or recommended, but not  
99   required.  
100   II.  Background  
101   FDA uses a variety of tools5  for oversight of FDA-regulated  products and  establishments. During the 
102   COVID-19  pandemic, FDA used RRAs  to help the Agency conduct oversight, mitigate risk, and meet  
103   critical public health needs  with respect to  certain  FDA-regulated products. RRAs have included: (1)  
104   mandatory RRAs  involving  review  of records  or other information submitted by  certain  establishments 
105   upon request  from FDA  under  section 704(a)(4)  of  the FD&C Act  and review of  records from  food 
106   establishments subject  to  FD&C Act  section  8056  (the latter  hereinafter referred to as requests for  
107   Foreign Supplier Verification Program (FSVP)  records under 21 CFR 1.510(b)(3) or  1.512(b)(5)(ii)(C)); 
108   and (2) voluntary RRAs involving remote requests for records and/or interactive  evaluations (such  as  
109   remote livestreaming video of operations, teleconferences, and screen sharing).  
110   FDAs experiences have identified  significant benefits  in using RRAs. For  instance, RRAs have assisted  
111   FDA in  verifying corrective actions taken in response to inspections  of previously compliant  
 
3  See, e.g.,  FDAs November 2021 An Update to the Resiliency Roadmap for FDA Inspectional Oversight,  where 
we reported on the  use  of RRAs as a tool to fortify FDA oversight efforts throughout the  pandemic.  
4  See,  e.g.,  question A.2. describing to whom voluntary and mandatory  RRAs may apply.  
5  See, e.g.,  the discussion of  alternative tools  used for oversight  listed  in FDAs May 2021 Resiliency Roadmap for  
FDA Inspectional Oversight,  and Section 704 of the Federal Food, Drug, and Cosmetic  Act  (FD&C  Act) (21 
U.S.C.  374).  
6  Section 805  of the FD&C Act  requires  importers as defined for purposes of section 805 of  the FD&C Act  to  
perform certain risk-based  Foreign Supplier  Verification  Programs  (FSVP)  activities. Further,  section 805(d)  of the  
FD&C Act provides for  FSVP records  to  be made available  promptly to the FDA upon request.  The FSVP  
regulation states  that, if requested in writing  by FDA, records must be sent to FDA electronically, or through any 
other means that  delivers the records promptly,  rather than making them available for review at  an importers  place 
of business. 21 CFR 1.510(b)(3), 1.512(b)(5)(ii)(C).  
4  
  Contains Nonbinding Recommendations  
Draft   Not for Implementation  
 
 
112   manufacturers7  and in gaining compliance  insight when it was not practicable to inspect. RRAs  have also 
113   provided information about  deficient practices, leading  FDA to  take  regulatory actions  and/or  conduct  
114   inspections,  as well as  informing  future inspection planning.  RRAs  were  used to help support  review  and 
115   promote timely approval or authorization of  marketing submissions for FDA-regulated products. In the  
116   food program,  RRAs  have assisted  in  determining  compliance with  veterinary  feed  directive regulations, 
117   assessing  foreign manufacturing  process records, adding  foreign establishments  to import alerts, and 
118   issuance of  warning letters.   
119   Based on these experiences, FDA has determined that  RRAs are valuable and, therefore,  under certain 
120   circumstances,  should be continued  to assist FDA  in its  mission to protect  public health, oversee regulated  
121   industry,  and ensure all  types of regulated products  comply with FDA requirements.  
122   With  respect to  section  704(a)(4),  this provision of  the FD&C  Act,  including as recently  amended  by the  
123   Food and Drug Omnibus Reform Act of 2022 (FDORA),8  gives FDA authority to request  (and requires  
124   establishments  to provide)  any records or other  information that FDA  may inspect under  section 704 of  
125   the FD&C Act, in advance  of or  in lieu of inspections  of  such  establishments that engage  in the 
126   manufacture,  preparation, propagation, compounding, or processing of  a drug or device,9  or a site or  
127   facility that is  subject to inspection under  section 704(a)(5)(C) (i.e., sites, entities,  or facilities  subject to  
128   bioresearch monitoring  (BIMO) inspections).   
129   The Agency believes  that FDAs use  of both mandatory and voluntary  RRAs,  as applicable,  for all  types  
130   of FDA-regulated products  is in the interest of the public health, and the Agency is issuing this  guidance 
131   to provide further  transparency to stakeholders  about the circumstances in which  mandatory and  
132   voluntary  RRAs may be used.  
133   The Agency is  also issuing this guidance to promote greater consistency  in  the way RRAs are conducted, 
134   including explaining processes  for  responding to an RRA request, and outlining factors we use for  
135   evaluating whether an establishment has responded timely and appropriately  to a mandatory  request.  
 
7  In  instances where FDA has identified objectionable conditions regarding compliance with laws and regulations  
enforced by FDA (e.g.,  Current Good Manufacturing Practice  requirements  for FDA-regulated products),  FDA may  
subsequently  determine compliance based  on a voluntary commitment of corrective actions, or,  when warranted,  
FDA may  pursue  a regulatory action. If FDA pursues a regulatory action  after conducting an RRA, we  generally  
will conduct an inspection to confirm that corrective actions  have been implemented; however, for certain regulatory 
actions and with respect to select instances involving certain programs, FDA could determine that an RRA is  
appropriate.    
8  FDORA was enacted as part of the Consolidated Appropriations Act, 2023, Pub. L. No.  117-328 (2022).  FDORA 
sections 3611(b)(1)(A) and 3612(a)  added  device and bioresearch monitoring  establishments  as establishments that 
are subject to mandatory  requests for  records or other information under  section 704(a)(4)  of the FD&C Act  (21 
U.S.C.  374(a)(4)).  
9  The terms drug and device  are defined at  FD&C Act sections 201(g)(1) and (h), respectively. With respect to  
drugs, a  drug  includes  human and animal drugs (including all compounded  human and animal drugs), and 
biological  drug products  for humans.   
5  
  Contains Nonbinding Recommendations  
Draft   Not for Implementation  
 
 
136   III. Questions and  Answers  
137   This section is  intended to provide FDAs current  thinking regarding the requesting, conducting, and use 
138   of RRAs by FDA.  
139   A. Remote Regulatory  Assessment Fundamentals  
140   1. What is an RRA?  
141   An RRA is an examination of an FDA-regulated establishment  and/or  its records, conducted entirely 
142   remotely,  to evaluate compliance with  applicable FDA  requirements. RRAs assist in protecting  human 
143   and  animal health, informing regulatory decisions, and verifying  certain  information submitted to the  
144   Agency.  
145   RRAs are a  tool FDA may use to support regulatory decisions  and oversight activities. Mandatory RRAs 
146   are conducted under  legal authorities  mandating the  establishments participation. Requests for records  or  
147   other information from establishments  subject to  section 704(a)(4) of the FD&C  Act,  and  requests for  
148   FSVP records under 21 CFR 1.510(b)(3) and 1.512(b)(5)(ii)(C),  are included among RRAS that are  
149   mandatory. RRAs  that are  not conducted under statutory or  regulatory authorities  mandating an 
150   establishments participation  are  voluntary in that an establishment  can decline to participate or withdraw  
151   participation during the RRA, in which case  the Agency may consider other tools  for evaluating 
152   compliance with FDA requirements.   
153   RRAs  complement  FDAs  authority to conduct inspections under section 704(a)(1) of  the FD&C Act and 
154   other  applicable FDA  authorities. RRAs do not  limit  the authority of FDA to conduct  inspections under  
155   section 704(a)(1) of the  FD&C  Act and other  applicable FDA  authorities.  
156   2. Who may be subject to an RRA?  
157      Mandatory  RRAs  
158   Mandatory RRAs  include  those  conducted for: (1)  establishments  that  are subject  to section 704(a)(4) of  
159   the FD&C Act10; and  (2)  importers, as defined  in  21 CFR 1.500, that are subject to FSVP under  section  
160   805(d) of  the FD&C Act  and implementing regulations in 21 CFR 1.510(b)(3) or 1.512(b)(5)(ii)(C), as  
161   applicable.11   
 
10  As  described  above,  section  704(a)(4)s  mandatory  records request  authority  applies to drug and device  
establishments  and  to  sites, entities,  or  facilities  subject to  BIMO inspections. See footnote  8  for information on 
recent  amendments  that made  device  establishments and BIMO  sites, entities, and facilities subject to  mandatory 
records request  authority  under section 704(a)(4) of the FD&C Act.  
11  As discussed  above, RRAs have included these mandatory remote requests for records or  other information.  
Although they  are discussed  in  this draft guidance  in response to certain  frequently asked  questions, RRAs 
conducted under section 704(a)(4)  or under FSVP  are not  necessarily  the only types  of mandatory RRAs  for which 
FDA has authority.    
6  
  Contains Nonbinding Recommendations  
Draft   Not for Implementation  
 
 
162   Upon initiating a  mandatory  RRA, FDA intends to  make clear  the  authorities under which the RRA is  
163   being requested.  
164      Voluntary RRAs  
165   If  an RRA is  not  mandated  by statute or regulation  (or  FDA opts against  exercising its mandatory RRA  
166   authority in  a certain instance), FDA  may request that  any establishment (e.g., food producers, tobacco 
167   product manufacturers,  drug  or medical  device manufacturers12,13, clinical investigators, or others) 
168   participate in a voluntary RRA.  
169   3. Are  RRAs replacing other established means of  obtaining information outside of  
170   inspections?  
171   No, RRAs are not  intended  to limit or  replace other established means  of obtaining information necessary  
172   for FDA to accomplish its  public health mission outside of  inspections, including, among other  things, 
173   applicant information request letters, registration  confirmations,  meetings,  product  submission,  
174   application assessments, or  follow-up  communications  during outbreaks  or other emergencies.  Similarly,  
175   if, for example, FDA  calls an applicant  to inform  them that a submission or  application is missing certain 
176   information, this is  not  an RRA.  Although these activities may be conducted remotely, the Agency does  
177   not consider  these RRAs.14  
178   4. Is an RRA an inspection?  
179   An RRA is  not an inspection under  sections  704(a)(1)  or  704(a)(5) of the  FD&C Act. Generally,  an 
180   inspection,  such  as described  in section 704(a)(1)  of  the FD&C Act, involves  duly designated officers or  
181   employees of the FDA  physically entering (at  reasonable times  and in a reasonable  manner), 
182   establishments subject  to regulation under the  FD&C Act  to determine  compliance  with applicable  
183   requirements.15   
184   However, because remote  requests for  FSVP records  are  under the authority of  section 805(d) of the  
185   FD&C Act and  FDAs implementing regulation, these  record requests function  as inspections  in that FDA  
186   uses these records requests to  evaluate  a food importers compliance with FSVP.  
 
12  In this draft guidance,  references to drug  and device  manufacturers  means  establishments that engage in the 
manufacture, preparation, propagation, compounding,  or processing of a drug  or device, respectively. See, e.g.,  
section 510 of the  FD&C Act and 21 CFR 207.1  and 807.3.   
13  By virtue  of applying to both drug and device establishments, section 704(a)(4)  of the FD&C Act  also  applies to  
establishments that manufacture, prepare, propagate, compound,  or process  combination products (see section 
503(g)(1)(C) of the FD&C Act) and the  drug and device constituent part(s) (defined under  21 CFR Part 4) of such 
combination products. Establishments that engage in the manufacture, preparation, propagation, compounding, or  
processing of combination products that are not subject to the authorities under section 704(a)(4)  of the FD&C Act  
may  voluntarily participate  in an  RRA.  
14  FDA intends to clearly indicate when we  consider  an activity to be an RRA so  establishments can differentiate  
RRA interactions  from non-RRA interactions.    
15  FD&C Act,  section 704(a)(1).  Relatedly,  for requests for records and other information under  section 704(a)(4), 
FDA does  not intend to issue a Form FDA 482, Notice of  Inspection or Form FDA 483, Inspectional Observations  
during the RRA process.   
7  
  Contains Nonbinding Recommendations  
Draft   Not for Implementation  
 
 
187   5. When may FDA initiate or request to conduct an RRA?  
188   FDA may initiate  or, in the case of  a voluntary RRA,  request  to conduct,  an RRA whenever we determine  
189   an RRA is appropriate to help fulfill  the Agencys  regulatory responsibilities  and protect human and 
190  animal health. For example:  
191      When FDA cannot conduct an inspection due to travel  limitations brought on by public health 
192   emergencies, natural disasters, or other  situations  making travel infeasible.  
193      When FDA determines that an RRA will assist  us  in  conducting  elements of  establishment  
194   oversight or support regulatory decisions. Examples  include preparing for an already planned 
195  inspection, following up on a consumer complaint, assisting in  verifying that an 
196   establishment has completed certain corrective actions (e.g.,  in  response  to  a  previous  
197   inspection,  or previous RRA), or supporting the review of a  marketing submission.   
198   FDA intends to  use a risk-based  approach  to determine whether to initiate or request  an RRA.  Factors that 
199   may be considered include, but are not  limited to,  establishment  location, inspection history, complexity  
200  of product and process, and  travel restrictions. Programs and centers within FDA  may  assess risk  
201   differently based on those factors.  
202   The above examples are illustrative,  and  the ultimate decision  to  initiate or  request an RRA rests with  
203   FDA,  as we retain  discretion to deploy RRAs as appropriate.  FDA does  not  accept requests to perform an  
204   RRA. When FDA determines an  inspection  (as opposed to an RRA)  is necessary, FDA intends to perform  
205  an inspection.   
206   6. Will FDA use RRAs during or as part of an FDA inspection of an establishment?  
207   No, FDA does not plan to conduct  RRAs  and inspections16  of an establishment  under sections 704(a)(1)  
208   or 704(a)(5) of  the FD&C  Act  simultaneously. An RRA is conducted remotely by FDA staff  without  
209   FDA staff present  at an establishment  conducting an inspection. However, an RRA could precede,  
210  prompt, or be a follow-up to,  an inspection. When an RRA precedes an inspection, FDA  will generally  
211   conclude  the RRA prior to initiating the inspection. FDA may combine any information gained from  the  
212   RRA  with any resulting observations from the subsequent inspection. In such circumstance, FDA  would 
213   confirm  any  observations  from the RRA during the  subsequent  inspection before  including  them on any  
214   Form FDA 483 Inspectional Observations  issued at the  conclusion of the subsequent inspection.   
215  Additionally, FDA may conduct an  RRA following an inspection in  order to conduct follow-up activities  
216   with the establishment  or  to assist in  verifying  corrective actions, if  appropriate.  
217   FDA may  decide to  conduct  an RRA (e.g., livestreaming) during oversight activities  independently 
218   conducted by state  or  foreign regulatory partners.17   
 
16  FDA considers inspections  that  are done with state officers  or employees duly commissioned under  702(a)(1)(A)  
of the FD&C Act  to be FDA inspections for the purposes of  this  draft  guidance.  
17  Generally,  FDA does not intend to conduct RRAs during Medical Device Single Audit Program  (MDSAP) audits.   
8  
  Contains Nonbinding Recommendations  
Draft  Not for Implementation  
 
 
219   7. What are the benefits  of an RRA?  
220   FDA, industry, and the general public can all benefit from RRAs  as RRAs help the Agency to meet 
221   critical public health  needs. These potential benefits may include, but are not limited to:   
222      Allowing FDA to  remotely  evaluate compliance of FDA-regulated products, clinical  studies, 
223   and establishments, as appropriate. This may  identify  issues  that lead  establishments to  
224   promptly make  corrective  actions, which may enhance the  establishments  preparedness for  
225   their next FDA  inspection.  
226      Having an RRA precede  an inspection under section 704(a) of  the FD&C Act could reduce  
227   resource expenditure. For example, FDA  may not need to review as  many records  during the  
228   inspection,  reducing the time FDA is present  at  the establishment.    
229      Helping to support  timely  regulatory decisions (including the  approval of an application or  
230   authorization for  emergency use), without an inspection, when appropriate conditions are  
231   fulfilled, such as the ability  to verify information in the  marketing submission. In such cases,  
232   the application approval, or the authorization, must  still meet applicable standards.  
233      Providing FDA additional information to incorporate  into a  risk-based inspection schedule, 
234   thereby helping FDA use inspectional  resources  more efficiently and effectively.  
235      Assisting FDA in verifying corrective actions.18  
236   B. Remote Regulatory  Assessment  Expectations  
237   8. How may FDA request an RRA?  
238   FDA may use  multiple processes for  requesting voluntary or  initiating mandatory  RRAs.19  
239      In general, for Voluntary RRAs  
240      FDA expects to  contact  an establishment  through the establishments  point of  
o
241   contact,20 by email or phone, once we determine an RRA is appropriate based on  
242   FDA  mission needs.  
 
18  See footnotes  2  and 7.   
19  When  finalized,  this draft guidance will represent the Agencys current thinking on  how RRAs  apply generally  to  
all FDA-regulated  products. Other  Agency  documents  may exist that provide additional information  about RRAs 
with respect  to specific  circumstances. See,  e.g.,  FDA Staff Manual Guide 9004.1, Policy and Procedures for  
Requesting Records in Advance of or  in Lieu of a Drug Inspection; FDA Compliance Program Guidance Manual  
7303.878, FSVP Inspections; Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring 
Facilities,  Draft  Guidance  for Industry,  October 2023.  
20  FDA will typically request to  speak with an establishments  owner, operator, or agent in charge at the site  (i.e.,  top 
management official  at the site),  or their designee.  
9  
  Contains Nonbinding Recommendations  
Draft   Not for Implementation  
 
 
243      FDA may use the establishments registration, establishment information provided in 
o
244   a marketing submission, or additional  information available  to FDA, to identify the  
245   point of  contact, authorized official, or U.S. agent.  
246      FDA will obtain the establishments consent  to the RRA  before we begin  the RRA. 
o
247   Where practicable, FDA generally  intends to  seek to obtain such consent in writing. 
248   This typically includes:  
249     notifying the establishments  point  of contact  of the  purpose and planned 
250   scope of the  RRA  and of  the  right to refuse consent;  and   
251     requesting that such person  confirm the establishment voluntarily consents  
252   and has the ability to participate  in  the voluntary RRA requested.  
253      If the establishment consents to the voluntary RRA, FDA will typically  provide an  
o
254   opportunity to discuss, as applicable and appropriate:  
255     FDAs expectations  for, and any establishment limitations in participating in, 
256   the RRA.  
257     The  scheduling of virtual interviews and meetings.  
258     Technological capabilities.21  
259     The process  and timeline  for requesting records or other information for  
260   review.  
261     How and when FDA  will provide feedback to the establishment.  
262     Any questions relating to the process  or other aspects of the RRA.  
263      In general, for  Mandatory  RRAs  
264      FDA  will initiate the request in accordance with  the relevant  legal authority and 
o
265   intends to follow any  established procedures.  
266     For  example, for  purposes of  section 704(a)(4) of the  FD&C Act, FDA will 
267   use Form FDA 4003  (for drug establishments)  or  a similar method for  other  
268   establishments subject  to  section 704(a)(4)  to  request records or other  
269   information.22  When making a  section 704(a)(4)  request, FDA will, under  
270   this  statutory  authority,  provide  a sufficient description of the records  or  
271   other information  requested, as well as our  rationale  for  requesting such 
272   records or other information in advance of, or  in lieu of, an inspection.23  
 
21  Any technical requirements, as applicable, will be discussed between FDA and the  establishment  prior  to or  
during  an opening meeting.  In conducting the RRA, FDA will  determine best logistical approaches and/or  
technology methods, as applicable, in coordination with the  establishment.  
22  The point of contact listed in the registration may be used as the point of contact.  For pre-approval  and pre-
licensing inspections,  there may be situations when records are requested of an establishment under section 
704(a)(4)  of the FD&C Act  related  to products named in multiple applications. In these situations,  FDA intends to 
issue  one Form FDA 4003 to the establishment to cover requests for records or other information for all of the  
products in the applications being assessed.   
23  See section 704(a)(4)(A)  of the FD&C Act, as amended by FDORA.   
10  
  Contains Nonbinding Recommendations  
Draft   Not for Implementation  
 
 
273   Upon receipt of the  requested records,  we  will  provide confirmation of  
274   receipt  to the  establishment.24  
275     Under  21 CFR 1.510(b)(3)  and 1.512(b)(5)(ii)(C)  for imported foods, FDA  
276   uses Form FDA 482d to request  FSVP records.  
277   Regardless of whether  an RRA is mandatory or voluntary, FDA does  not  intend to  issue  a Form FDA 
278   482, Notice  of Inspection  as part of the RRA process.25  
279   9. What might an establishment expect to happen during an RRA?  
280   RRAs may entail, but are not limited to, any combination of  the  following, depending on the  type of RRA  
281   involved:  
282      FDA requests and  reviews records and other  information (such as electronic systems,  and  
283   source records  from non-clinical and clinical studies).   
284      Virtual  meetings between FDA and responsible establishment personnel to review, where  
285   appropriate, the information provided  to FDA, the  establishments  electronic systems, the 
286   establishments operations, and/or the establishments  standard operating procedures. 
287   Interactions  beyond the virtual  meeting  between  FDA  and an establishment may continue  
288   during the course of  an RRA.  
289      Use  of  livestream  and/or  pre-recorded  video, where appropriate,  to examine  facilities,  
290   operations,  data, and other  information.  
291   FDA may review electronic systems and source records by screen  sharing and  livestream/video.26  FDA 
292   may provide  updates  to  the  establishment  on  observations  and  outstanding  issues,  whenever  feasible,  
293   throughout the  RRA.  FDA expects to  make reasonable and appropriate  efforts  to discuss observations 
294   with the  management of  the establishment, to  minimize surprises, errors, and misunderstandings.  
295   While mandatory  RRAs  that are conducted under  their respective  relevant  authorities  involve  activities  
296   detailed by such authorities, an establishment could agree  to participate  in activities beyond what is  
297   required. For instance, FDA  may request that  an  establishment subject to a  section  704(a)(4) records  
298   request  instead  voluntarily participate in  an  RRA  that accommodates review through  interactive  
299   technologies such as video  streaming.  
 
24  See section 704(a)(4)(B).  
25  See  footnote 15.   
26  FDA does not intend  to record  RRAs  conducted via livestream, video, or screen sharing;  however, FDA may  
request  records  we review during those sessions.  
11  
  Contains Nonbinding Recommendations  
Draft   Not for Implementation  
 
 
300  10. Are there any  consequences for declining to participate in an RRA?  
301      Voluntary RRAs  
302   Because of  the voluntary nature of  these assessments,  declining  to participate in a  voluntary RRA will not 
303   result  in any enforcement action by the Agency based on the  declination.27  FDA may consider other  
304   activities necessary to exercise our  oversight  responsibilities  regarding  that establishment, such as an  
305  inspection, based on considerations such as when  the establishment was last inspected,  our  assessment of  
306   risks,  and  other relevant factors. An establishment may  decline  to participate  in  a voluntary RRA, but  an  
307   establishment  may not  opt out  of  an FDA inspection.    
308   Moreover, if  an establishment declines FDAs  request  to conduct a voluntary RRA, FDA may not be  able  
309   to assess the establishments activities until  we  exercise  other  oversight tools. Indeed, a  voluntary RRA  
310  may be the most expedient  means for FDA to assess the establishment, especially when  factors prevent  
311   FDA from conducting a  timely  inspection. For example, in circumstances  which temporarily limit FDAs  
312   ability  to  conduct an inspection,  such as travel restrictions,  it may take FDA  longer  to assess an  
313   establishment  or, for example, a  marketing submission in which an establishment  is referenced,  absent an  
314   RRA  because we lack  necessary  information.  
315     Mandatory RRAs  
316   FDA may deem  the following actions, among others, as  declining  to participate  in a mandatory RRA:  
317   failing to respond, withdrawing participation,  and  refusing to provide  records  upon a lawful request. 
318   There  are consequences for declining mandatory RRAs. For  example, an  establishment that refuses a 
319   request  for records or other  information under  section 704(a)(4) of  the FD&C Act  may be in violation of  
320  the FD&C Act.28   
321   Similarly, if an importer refuses FDAs written  request for FSVP  records  under  21 CFR 1.510(b)(3) or  
322   1.512(b)(5)(ii)(C),  the importer may  be  in violation of section 805 of the  FD&C Act, and the  food offered 
323   for import  by the  importer  may be subject to  refusal  under  section 801(a)(3) of  the FD&C Act.29   
324   FDA intends to  take  appropriate action against  persons30  and  products  that are in violation of  the FD&C  
325  Act.   
326   11. Are there any technological expectations for an RRA?  
327   The technological expectations will vary depending on the  type of RRA and its scope. Certain RRAs  
328   involve records  requests,  and the  records may be  submitted electronically or through other  means. Other  
329   RRAs may  require additional technological capability. For example, if FDA expects  that the RRA  could  
330  include  the  use of live streaming video, FDA  may inquire  about hardware or internet connectivity to 
331   assess IT operability, security, and privacy controls to protect the confidentiality of the data. The quality 
 
27  This would not be considered a refusal  for purposes of  section 301(e)  or (f), or  807,  of the FD&C Act.  
28  See  e.g.,  section 301(e) of the FD&C Act (Prohibited Acts).    
29  21 CFR 1.514(a).   
30  See section  201(e)  of the FD&C Act  (Definitions).  
12  
  Contains Nonbinding Recommendations  
Draft   Not for Implementation  
 
 
332   of the remote  connection (e.g., connectivity,  image quality, cameras used)  should be adequate for FDA to  
333   review, observe, examine, and evaluate  the  requested records, documents, and other information 
334   (including electronic systems). To the extent practicable, technologies employed should also  allow access 
335  for  remotely viewing and evaluating operations at  the  establishment, as appropriate (e.g., aseptic  
336   practices, equipment cleaning and set  up, material weighing and dispensing, instrument set up, sampling, 
337   and testing).  
338   If an establishment is unable to  support  streaming video or other live virtual  interactions, or if FDA  
339   determines that the streaming video or any other virtual interaction during the RRA does not permit a  
340  sufficient examination of the establishment  or of a corrective action, FDA  may  use other  available tools 
341   or may terminate the RRA  and consider other actions necessary to exercise our oversight responsibilities 
342   regarding  that establishment,  such  as an inspection.  
343   Recommendations  for sending records or other information are further explained in question 15, below.  
344   C. Requests for Records or Other Information  as Part of  Remote Regulatory Assessments  
345  12. What records or other information may FDA request as part of an RRA?  
346   For voluntary RRAs, FDA  may request  records or other  information appropriate  to determine  whether  an 
347   establishment  or  FDA-regulated  product  or  clinical study  is  in compliance with applicable  requirements. 
348   The records and other  information will typically be  similar to what  FDA would request during an 
349   inspection under  section 704(a)(1)  of  the FD&C Act.  
350  In the case of  mandatory RRAs,  the  records or other information we  request, and  the circumstances under  
351   which we  request them, will conform  to the  relevant legal authority.  For example,  under section 
352   704(a)(4)  of the FD&C Act, FDA  may request any records  or other information subject to inspection 
353   under  section 704. For  mandatory  RRAs under  21 CFR 1.510(b)(3)  and  1.512(b)(5)(ii)(C), FDA may  
354   request  any and all  records  that are required to be maintained under  21 CFR 1, Subpart L.  
355  Examples of  records or other information the Agency may request during a  voluntary  or mandatory  RRA  
356   include, but  are  not limited to:  
357      Records of  specific production lots or batches as well  as product-specific information, such as 
358   periodic  product reviews,31  product  quality reports,  equipment records,  process validation 
359   records and reports, test results,  records of  product  postmarket defects  or  other  information 
360  related  to compliance with Current  Good Manufacturing  Practice requirements.   
361      Certain  summaries or lists of records, such as a summary of batches manufactured  and  their  
362   disposition, or  a summary of discrepancies and investigations related to manufacturing and 
363   testing.   
 
31  See 21 CFR 211.180(e).  
13  
  Contains Nonbinding Recommendations  
Draft   Not for Implementation  
 
 
364      Read-only access to  electronic databases32  or  a request  that an establishment walk us through 
365  information in their database or provide data queries or summary data  generated by the  
366   establishment from their databases.   
367      Standard Operating Procedures  and records generated by the establishment to document  
368   control of quality systems  and/or to demonstrate  compliance with the  applicable FDA  
369   requirements.  
370     For FSVP importers,  records  related to  hazard analysis,  the importers  determination of  
371   appropriate supplier  verification activities, performance of supplier verification activities,  
372   and/or corrective actions.  
373      For establishments subject  to BIMO inspection,  records or data  related to the reporting or  
374   conduct of FDA-regulated research.  
375  Where applicable,  FDA intends to take  appropriate efforts to minimize  the quantity of records or other  
376   information requested and may request  that  establishments take reasonable efforts to  facilitate and  
377   expedite FDAs collection and review of  records. See  questions 14 and 15 for  additional details.  
378   13. For what purposes may FDA use the  records  and other information gathered during  an 
379   RRA?  
380  Depending on the scope  of  the RRA, the information and documentation may be  used by FDA  for, among 
381   other  things,33  the  following regulatory purposes:  
382      Support  FDAs assessment of  pending marketing submissions, including whether  to approve  
383   an application  or whether to issue a  response, such as  a complete response letter.34    
384      Determine whether an establishment  or product  is or is not  in compliance with certain FD&C  
385  Act or PHS Act  requirements, and other  applicable requirements.  
386      Facilitate assessment of  the need for  an inspection in follow-up to a  reported concern or  
387   defect.  
388      Support actions such as a  regulatory meeting, warning letter, import action, recall  activity, or  
389   other  advisory  action, or to support  an  administrative  or  judicial  action.  
390     Determine  the priority of establishments for inspection, particularly a surveillance  inspection.  
 
32  See FDA Investigations Operations Manual (IOM)  5.10.2.1.  
33  See,  e.g.,  section 704(a)(4)(C)  of the FD&C Act, as added by FDORA.  
34  A complete response letter is either a written communication to an applicant  from FDA usually describing all  of  
the deficiencies that the Agency has identified in a new drug application or abbreviated new drug application  that 
must be satisfactorily addressed before it can be approved (21 CFR 314.3);  or a written communication to an  
applicant from FDA  usually describing all of the deficiencies that the agency has identified in a biologics license  
application or supplement that must be satisfactorily addressed before it can be approved  (21 CFR 600.3(ll)); see  
also 21 CFR 314.110 and 21 CFR 601.3.    
14  
  Contains Nonbinding Recommendations  
Draft  Not for Implementation  
 
 
391   14. If the RRA requests records or other information, what is the timeframe for submitting  
392   the records  and other information to FDA?  
393   For  mandatory RRAs, FDA will request that records and other information be submitted within  a 
394   timeframe  consistent with the relevant legal  authority.35 For voluntary RRAs, FDA  may suggest  
395   timeframes to ensure the RRA is completed in a reasonable amount of  time and  expects establishments to  
396   work diligently to provide the  requested records  and other information.   
397   The circumstances that relate to FDAs expectations for reasonable request  timeframes may include:   
398      The size,  available resources, and  capabilities of the establishment, including those that might  
399   exist for small businesses.  
400      The type, complexity, and volume of the records  and other  information being requested.  
401      The reason for the request, such as an application action  goal date, deadline, or other time-
402   sensitive reasons.  
403      Need for translation of  records.  
404   15. How should records or other information in response to an RRA request be provided to 
405   FDA?  
406   Except as provided below, requested records or other information generally should be submitted in an 
407   electronic format. FDA  intends to  provide  a secure means to send requested records and information. For  
408   electronic documents, establishments should identify any limitations on external  access and ensure that  
409   encrypted and password-protected  files can be accessed by FDA. FDA will follow applicable federal law  
410   governing the confidentiality of  records  and information submitted to the Agency (see, e.g., 5 U.S.C. 
411   552(b)(4), 18 U.S.C. 1905, 21 C.F.R. Part 20).  
412   FDA recognizes that  some establishments  maintain documents in paper format. Requested documents  
413   maintained in paper  format  should be scanned as searchable Portable Document Format  (PDF)  files, when 
414   possible, and sent  by the secure means identified by FDA. If a paper format  is  the only option for sending 
415   copies of records, FDA will provide  the name and contact  information of  the FDA staff  member  to whom  
416   the records should  be  sent.  
 
35  For  example, for  RRAs under  section  704(a)(4)  of the FD&C Act, persons subject to the request must provide the  
requested records  or other  information within a  reasonable timeframe, within  reasonable limits, and in a reasonable 
manner.  See Section 704(a)(4)(A). See also FDAs Staff Manual Guide,  9004.1, Policy and Procedures for  
Requesting Records in Advance of or in lieu of a Drug Inspection for more information on timeframes. For RRAs  
under  section  805(d)  of the FD&C Act, persons subject to the request must provide the records promptly.  FDA 
generally expects FSVP records to be sent within 72 hours of the request. See FDAs Guidance for Industry: Foreign  
Supplier Verification Programs for Importers of Food for Humans and Animals,  available here: 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-foreign-supplier-
verification-programs-importers-food-humans-and-animals.  
15  
  Contains Nonbinding Recommendations  
Draft  Not for Implementation  
 
 
417   FDA may request  that records  and other information be in English or accompanied by an English 
418   translation.36  If translated, the translation should be complete and accurate, and, when applicable, should 
419   include  the  name, address, and a brief statement of the  qualifications of the translator. Copies of  the  
420  original records  and information should also be included in the response, where appropriate. For certain  
421   RRAs, if  a verified  translation  is not immediately  available,  FDA may request that  the initial translation  
422   be followed up with  a verified translation as soon  as practicable.   
423   If  the records or other information are provided as part of a  section  704(a)(4)  request, the records and 
424   information  may be submitted in either electronic  or physical  form. FDA will  provide confirmation upon 
425  receipt of  the records.  37 In general, FDA intends  to maintain open communications  to discuss any records 
426   received over the course of  the RRA.  
427   For RRAs under 21 CFR 1.510(b)(3) and 1.512(b)(5)(ii)(C), records must be sent  electronically, or  
428   through any other  means  that delivers the records promptly upon written request from FDA.  
429   D. Completion of a Remote Regulatory Assessment   
430  16. What may occur upon completion of an RRA?  
431   Upon completion of an RRA, FDA may have a  closeout  meeting38  with the establishments management.  
432   At the closeout meeting,  FDA may present  a written  list of RRA observations, if  any, and describe and 
433   discuss such observations in sufficient detail to enable  understanding and foster an appropriate response. 
434   For purposes of this guidance,  RRA observations  are defined as conditions and/or  practices observed  
435  during the RRA that  indicate, in the  judgment of the FDA employee(s) conducting the RRA, a  potential  
436   violation of the laws enforced by FDA. FDA does  not  intend to issue a Form FDA 483, Inspectional  
437   Observations, for an RRA.39  (See question 6 for a  discussion of how observations from an RRA  may be  
438   confirmed during an inspection and included on a Form 483).  
439   An establishment should be aware that  a written list of  observations may be subject to a request under  the  
440  Freedom of Information Act  at the time the disclosure to the establishment  is first  made (see  21 CFR 
441   20.101(a)) and may be  made publicly available, with applicable  redaction of information  that is exempt 
442   from public disclosure  (see, e.g., 5 U.S.C. 552(b), 18 U.S.C. 1905, 21 U.S.C. 331(j), 360j(c), 360nn(e), 
443   and 387f(c), and 21 C.F.R. Part 20).  
444   FDA encourages establishments to respond during  the meeting, and/or provide  written  responses to the  
445  observations within fifteen (15)  U.S. business  days. Responses or corrective actions submitted to FDA  
446   during that timeframe  in  response to the issues identified during the  RRA  generally will be considered 
 
36  For RRAs of FSVP importers, upon FDA request,  the importers must provide within a reasonable time an English 
translation of records maintained in  a language  other than English.  See  21 CFR 1.510(b)(1), 1.512(b)(5)(C)(ii)(A).  
37  Section 704(a)(4)(B)  of the FD&C  Act.  
38  There may be some instances where a closeout  meeting may not happen, such as for  some  requests under section  
704(a)(4)  of the FD&C Act.  In such circumstances,  FDA intends to notify the  establishment that the RRA is  
concluded, along with any pertinent information.   
39  FDA will use a Form FDA 483a, FSVP Observations,  to issue observations to an importer based on  RRAs that are  
FSVP record reviews under 21 CFR 1.510(b)(3) and 1.512(b)(5)(ii)(C).  
16  
  Contains Nonbinding Recommendations  
Draft   Not for Implementation  
 
 
447   before further Agency  action or decision.  Establishment responses are available for public disclosure as 
448   described in  21 CFR 20.103  with redaction of  non-public  information, as appropriate.  
449   FDAs written list of RRA observations is  not a final  Agency action or decision. However, evidence  
450   collected in the course of an RRA may be used in support  of such actions  or decisions.    
451   Following an RRA, FDA may conduct  an inspection. FDA may consider  other  actions, as appropriate,  
452   including an enforcement action.   
453   As part of  the RRA process, FDA  intends to  ordinarily  prepare  a report consisting of a narrative  and 
454   supporting documents that  communicates the summary of information reviewed,  conditions and practices  
455   found, and the  observations  identified. FDA generally expects to  provide a written copy of the narrative  
456   portion of  the RRA report40  to the establishment, following the  determination  that the RRA is closed  (see  
457   21 CFR 20.64(d)(3)).  At that  time,  the report and supporting documents, with any applicable  redactions,  
458   also  become  available for public disclosure upon request.  
 
40  There may be some instances where a report  may  not be  written or  provided, such as when the requested records  
under  section  704(a)(4) of the  FD&C Act  were used to prepare for an inspection  or for some requests for FSVP  
records under  21 CFR 1.510(b)(3) and 1.512(b)(5)(ii)(C).  
17