Remote Interactive Evaluations of 
Drug Manufacturing and 
Bioresearch Monitoring Facilities 
Guidance for Industry 
 
 
 
 
 
 
DRAFT GUIDANCE 
 
  This guidance document is being distributed for comment purposes only.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publication in the Federal Register of the notice announcing the availability of the draft 
guidance.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. 
 
For questions regarding this draft document, contact (CDER) Tina Kiang 301-796-6487; (CBER) 
Office of Communication, Outreach and Development, 800-835-4709 or 240-402-8010; or 
(CVM) AskCVM@fda.hhs.gov.  
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
Center for Veterinary Medicine (CVM) 
 
 
 
 
October 2023 
Pharmaceutical Quality/Manufacturing Standards (CGMP) 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
Remote Interactive Evaluations of 
Drug Manufacturing and 
Bioresearch Monitoring Facilities 
Guidance for Industry 
 
 
Additional copies are available from: 
Office of Communications, Division of Drug Information  
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD 20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov  
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs  
and/or 
Office of Communication, Outreach and Development  
Center for Biologics Evaluation and Research 
 Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 71, Room 3128 
Silver Spring, MD 20993-0002 
Phone: 800-835-4709 or 240-402-8010 
Email: ocod@fda.hhs.gov 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances 
and/or 
Policy and Regulations Staff, HFV-6 
Center for Veterinary Medicine 
Food and Drug Administration 
7500 Standish Place, Rockville, MD 20855 
https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
Center for Veterinary Medicine (CVM) 
 
October 2023 
Pharmaceutical Quality/Manufacturing Standards (CGMP) 
 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  PLANNING A REMOTE INTERACTIVE EVALUATION ....................................... 2 
A.  Selecting and Notifying the Facility .............................................................................................. 3 
B.  Preparing for a Remote Interactive Evaluation .......................................................................... 6 
IV.  CONDUCTING A REMOTE INTERACTIVE EVALUATION ................................. 6 
A.  Technological Requirements ......................................................................................................... 7 
B.  Remote Interactive Evaluation of Documents and Records ...................................................... 8 
V.  CONCLUDING A REMOTE INTERACTIVE EVALUATION ................................. 8 
VI.  TIMEFRAMES FOLLOWING COMPLETION OF A REMOTE INTERACTIVE 
EVALUATION ................................................................................................................. 9 
A.  Response Timeframes for All Inspection Programs ................................................................... 9 
B.  Response Timeframes for Remote Interactive Evaluations in Support of Preapproval and 
Prelicense Inspection Programs .................................................................................................... 9 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
Remote Interactive Evaluations of Drug Manufacturing and 
Bioresearch Monitoring Facilities 
Guidance for Industry1 
 
 
This draft guidance, when finalized, will represent 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 responsible 
for this guidance as listed on the title page.  
 
 
 
 
I.  INTRODUCTION  
 
FDA conducts inspections for many purposes and programs, ensuring necessary oversight of 
FDA-regulated products and assessing facilities compliance with the Federal Food, Drug, and 
Cosmetic Act (FD&C Act). FDA may use alternative tools, such as Remote Regulatory 
Assessments (RRAs)2, in advance or in lieu of an inspection or to support an inspection of a 
facility and assess compliance with applicable laws and regulations. For instance, if a program 
office determines that an inspection is not necessary, feasible, or practical, FDA may instead 
conduct an RRA. An RRA is an examination of an FDA-regulated establishment and/or its 
records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements. 
RRAs may consist of (or include) a request to conduct voluntary remote interactive evaluations.  
 
FDA is issuing this guidance to describe how we request and conduct voluntary remote 
interactive evaluations at facilities3 where drugs4,5 are manufactured, processed, packed, 
compounded, or held, and at drug facilities covered under FDAs bioresearch monitoring 
(BIMO) program. FDA may consider the use of a remote interactive evaluation for any of the 
inspection program areas described in Section III of this guidance.  
 
 
1 This guidance has been prepared by the Office of Pharmaceutical Quality in the Center for Drug Evaluation and 
Research in cooperation with the Center for Biologics Evaluation and Research, the Center for Veterinary Medicine, 
and the Office of Regulatory Affairs at the Food and Drug Administration.  
2 See the FDA draft guidance for industry Conducting Remote Regulatory Assessments  Questions and Answers 
(July 2022). When final, this guidance will represent FDAs current thinking on this topic. We update guidances 
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 In this guidance, the term facility covers persons, sites, entities, and establishments subject to FDA drug 
manufacturing and bioresearch monitoring regulations and statutory authority for drugs. 
4 A drug includes human and animal drugs (including drug products produced by facilities registered as human 
drug compounding outsourcing facilities under section 503B of the FD&C Act, and all compounded animal drugs), 
and biological drug products for humans. 
5 In this guidance, the term drug includes biologics. 
  1  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
Instead, guidances describe the Agencys 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 
 
During the Coronavirus Disease 2019 (COVID-19) pandemic, FDA expanded our use of 
alternative tools for evaluating drug manufacturing facilities to support regulatory decision-
making. When an inspection was not feasible or practical because of the public health 
emergency, FDA used other available tools and information to support regulatory decisions and 
oversight of facilities. Although inspections have largely resumed and the Secretary of Health 
and Human Services has announced that the COVID-19 public health emergency declaration has 
ended,6 FDA has determined that continued use of alternative tools, including remote interactive 
evaluations, based on risk and program needs, will enhance our ability to assess facilities. 
 
This guidance describes the various remote interactive tools we may request to use to conduct an 
evaluation. In this guidance, we refer to our use of any combination of these interactive tools as a 
remote interactive evaluation. FDA may request to conduct a remote interactive evaluation prior 
to or following other types of regulatory oversight activities (e.g., an inspection or a request for 
records or other information).7 
 
 
III.  PLANNING A REMOTE INTERACTIVE EVALUATION 
 
FDA may request to conduct a remote interactive evaluation whenever a program office 
determines it is appropriate based on mission needs and any travel limitations. FDA conducts 
inspections for many purposes and programs, and we will consider each of those inspection 
program areas as possible candidates for a remote interactive evaluation. This policy applies to 
all drug inspection programs including, but not limited to:  
  Preapproval Inspections (PAIs) and Prelicense Inspections (PLIs): FDA may perform a 
PAI or PLI to assess a marketing application. FDA uses these inspections to ensure that 
any facility named or referenced in support of an application can perform the proposed 
manufacturing operations in conformance with current good manufacturing practice 
(CGMP) requirements, to verify conformance with the application, and to confirm that 
data submitted in the application are accurate and complete. 
  Postapproval Inspections (PoAIs): PoAIs focus on a specific drug and changes to its 
 
6 https://www.hhs.gov/coronavirus/covid-19-public-health-emergency/index.html 
7 A remote interactive evaluation is not an inspection as described in sections 704(a)(1) or 704(a)(5) of the FD&C 
Act (21 U.S.C. 374(a)(1), 374(a)(5)) or a request for records or other information in advance of or in lieu of an 
inspection, as described in section 704(a)(4) of the FD&C Act (21 U.S.C. 374(a)(4)). Similarly, a remote interactive 
evaluation or a request under section 704(a)(4) does not constitute an inspection for purposes of sections 503B(b)(4) 
(21 U.S.C. 353b(b)(4)) and 510(h)(3) (21 U.S.C. 360(h)(3)) of the FD&C Act. 
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
manufacturing operations, the evaluation of process validation, any changes submitted 
to the application, and the execution of supporting activities according to application 
commitments and CGMP requirements. 
  Surveillance Inspections: Surveillance drug quality inspections examine overall 
operations, including controls that ensure manufacturing processes produce quality 
drugs, thereby reducing the risk of adulterated or misbranded drugs reaching consumers 
and patients. FDA uses surveillance inspections to evaluate the CGMP compliance of 
manufacturing operations. Surveillance inspections are performed at active 
pharmaceutical ingredient and drug product manufacturing facilities, as well as 
outsourcing facilities that have registered with FDA under section 503B of the FD&C 
Act (21 U.S.C. 353b). 
  Follow-Up and Compliance Inspections: When a specific drug quality problem or 
facility issue comes to FDAs attention, we may initiate a follow-up or compliance drug 
quality inspection. For example, FDA may conduct an inspection to investigate: (1) 
product safety, effectiveness, or quality concerns arising from defect reports; (2) 
information provided by an informant about a facility; (3) violative activities involving 
a facility that were discovered during the inspection of another facility; or (4) corrective 
actions undertaken by a facility in response to, for example, a warning letter or 
regulatory meeting. 
  Bioresearch Monitoring (BIMO) Inspections: The BIMO program is a comprehensive, 
Agency-wide program of inspections and data audits designed to monitor all aspects of 
the conduct and reporting of FDA-regulated research. The goals of the BIMO program 
are to protect the rights, safety, and welfare of research subjects; to verify the accuracy, 
reliability, and integrity of clinical and nonclinical trial data submitted to FDA; and to 
assess compliance with FDAs regulations governing the conduct of clinical and 
nonclinical trials, including regulations for informed consent and ethical review, and 
certain postmarketing requirements. 
 
A.  Selecting and Notifying the Facility 
 
FDA intends to apply risk management methods and tools to determine when to request a 
facilitys participation in a remote interactive evaluation. In some cases, FDA may request 
records or request that a facility participate in a remote interactive evaluation prior to an 
inspection. We do not intend to accept requests from applicants or facilities for FDA to perform 
a remote interactive evaluation. Such decisions depend on many factors and information not 
always known to applicants or facilities, and it would be unduly burdensome on all parties to 
establish a request-based program. 
 
Once FDA determines that a remote interactive evaluation is appropriate for a particular facility 
or drug, we intend to notify the facility and applicant (when appropriate) by electronic 
correspondence or phone call. We will use the facilitys registration or application information to 
identify the facility point of contact or U.S. agent. Correspondence or phone contact will include 
a request for confirmation of the facilitys willingness and ability to participate in a remote 
interactive evaluation, including the use of teleconference, livestream video, and screen sharing 
of data and documents. The request would indicate the name and address of the facility to be 
  3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
evaluated, the reason for the use of a remote interactive evaluation, and the names of FDA 
participants, if known in advance. Where practicable, FDA generally intends to seek to obtain 
such facility consent in writing. 
 
Following a facilitys agreement to be evaluated remotely, FDA will contact the facility to 
confirm the point of contact for the remote interactive evaluation, facilitate planning, and 
determine a facilitys ability to transfer records and perform remote interactions with FDA staff. 
FDA will identify the FDA lead for the remote interactive evaluation. FDA will also work with 
facilities to procure information necessary to plan and coordinate the activities for a remote 
interactive evaluation. The facility should meet these requests or inform FDA of any challenges 
in meeting these requests as soon as possible. 
 
Declining FDAs request to perform a remote interactive evaluation could impede our ability to 
make a timely regulatory decision (e.g., regarding adequacy of a clinical trial used in support of a 
pending application or adequacy of a drug manufacturing operation described in the application). 
 
1.  Specific Considerations for Preapproval and Prelicense Inspections 
 
When FDA cannot perform a PAI or PLI, when we determine it would be useful to supplement a 
planned inspection, or when we determine that facility risks can be assessed and application 
assessment can be completed without inspection, we will consider using tools other than 
inspection, selecting the most appropriate method to address the specific risks at issue. FDA may 
request a remote interactive evaluation to support an application action if we determine that: (1) 
remote interaction with the facility will help us assess risks identified during application review, 
and (2) there are no data integrity or other issues that FDA determines require an inspection.8 
 
FDA may request records and other information under section 704(a)(4) of the FD&C Act (21 
U.S.C. 374(a)(4)) before initiating a remote interactive evaluation. 
 
2.  Specific Considerations for Postapproval Inspections 
 
When FDA cannot perform a PoAI, or when we determine it would be useful to supplement a 
planned inspection, we will consider using tools other than inspection to address the specific 
risks that justify the need for the PoAI; we may determine that requesting a remote interactive 
evaluation is an appropriate alternative to conducting an inspection. FDA may request a remote 
interactive evaluation for PoAIs when: (1) a facility has an acceptable inspection history with no 
data integrity or other concerns that FDA determines require an inspection; and (2) specific 
application considerations and CGMP manufacturing risks that warrant a PoAI can be 
sufficiently assessed through a remote interactive evaluation. 
 
8 For criteria used to determine whether FDA will consider the use of a remote regulatory assessment or other 
alternative tools, see the FDA draft guidances for industry Conducting Remote Regulatory Assessments  Questions 
and Answers (July 2022) and Use of Alternative Tools to Assess Manufacturing Facilities Named in Pending 
Applications (September 2023), respectively. When final, these guidances will represent FDAs current thinking on 
these topics. We update guidances 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. 
  4  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
3.  Specific Considerations for Surveillance Inspections 
 
In prioritizing facilities, domestic and foreign, for remote interactive evaluations, we intend to 
follow the same risk-based approach currently used by FDA for surveillance inspections.9  
 
A remote interactive evaluation does not constitute an inspection for purposes of sections 
503B(b)(4), 510(h)(3) (21 U.S.C. 360(h)(3)), 704(a)(1), or 704(a)(5) of the FD&C Act. 
However, FDA may use information gathered via a remote interactive evaluation to determine 
the scope, depth, and timing of a future inspection. 
 
4.  Specific Considerations for Follow-Up and Compliance Inspections 
 
A follow-up or compliance inspection examines operations, records, and other information that 
relate to the specific issue being addressed (e.g., drug quality control, facility, or manufacturing 
problem). FDA will determine whether a remote interactive evaluation is appropriate, such as 
when an inspection cannot be performed due to travel restrictions or to supplement a planned 
inspection. The use of a remote interactive evaluation will depend on the nature of the facility 
and the reason for the assignment, including, but not limited to, inspection history and any data 
integrity concerns. 
 
After pursuing an advisory action (e.g., warning letter or regulatory meeting), FDA generally 
will conduct an inspection to confirm that corrective actions have been implemented. 
 
To evaluate defect reports (e.g., Field Alert Reports or Biological Product Deviation Reports), 
FDA may request a remote interactive evaluation and/or make a records request under section 
704(a)(4) of the FD&C Act. 
 
5.  Specific Considerations for Bioresearch Monitoring Inspections 
 
Selection of facilities for BIMO inspections is risk based. While some facility selection factors 
such as inspection history and time since last inspection may be common across BIMO 
programs, other factors are unique to each BIMO program.  
 
FDA intends to consider BIMO facilities for remote interactive evaluation according to existing 
risk-based facility selection methodologies when there are no data integrity or other concerns 
that FDA determines require an inspection, and information to be evaluated can be accessed 
remotely. Generally, FDA intends to use information obtained from a remote interactive 
evaluation to assess the facilitys conduct, including data reliability and human subject 
protections, to determine the acceptability of BIMO studies for FDAs application decision-
making. 
   
 
9 See, for example, the risk-based approach described in MAPP 5014.1 Understanding CDERs Risk-Based Site 
Selection Model, available at https://www.fda.gov/media/118214/download. 
  5  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
B.  Preparing for a Remote Interactive Evaluation 
 
Once the facility confirms its willingness and ability to participate in a remote interactive 
evaluation, FDA will schedule a brief virtual meeting to discuss logistics, responsibilities, and 
expectations. Discussion topics may include, but are not limited to, the following: 
  Objectives and scope of the remote interactive evaluation. 
  Introduction of the FDA remote interactive evaluation team and the remote interactive 
evaluation lead.  
  Identification of the facility point of contact and all other participants (e.g., sponsor or 
contract research organization, monitor, remote ancillary operations). 
  Schedule of virtual interactions and the anticipated duration of the remote interactive 
evaluation. 
  FDAs expectations during livestreaming walkthroughs of the facility. 
  Time zone differences and translation services (i.e., spoken and written translation), if 
applicable. Virtual interactions, including remote observation of manufacturing 
operations or livestream assessment of data, usually will occur during the facilitys 
normal business hours. 
  Methods for sharing requested information, including sharing documents and the use of 
video-streaming technology. 
  Technological limitations that could impair or prevent FDAs remote interactive 
evaluation of the facility.  
  Check of the internet connection throughout the facility to verify that the signal strength 
is adequate to support livestreaming video and audio during the actual remote 
interactive evaluation. 
 
 
IV.  CONDUCTING A REMOTE INTERACTIVE EVALUATION 
 
When facilities agree to participate in a remote interactive evaluation, FDA expects them to 
cooperate with the same level of transparency as they would during an FDA inspection. We 
expect appropriate staff to be available at scheduled times for interviews and other virtual 
interactions, and we expect the facility to be operational to the extent possible for FDA to 
evaluate areas and operations of interest (e.g., manufacturing, laboratory, packaging). If a facility 
is unable to support video or other virtual interactions, or if FDA determines that the video or 
any other virtual interaction during the remote interactive evaluation does not permit a sufficient 
examination of the facility or of a corrective action, FDA may terminate the remote interactive 
evaluation and instead perform an inspection or use other available tools. 
 
As part of a remote interactive evaluation, FDA may: 
  6  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
  Request and review documents, records, and other information (electronic systems).10 
  Use livestream and/or prerecorded video to examine facilities, operations, and data and 
other information.11 
  Through the facilitys point of contact, schedule interviews and meetings to address any 
questions or concerns. 
  Evaluate a facilitys corrective actions (e.g., in response to a previous inspection or 
evaluation, or to the current remote interactive evaluation). An inspection instead of a 
remote interactive evaluation may be necessary to verify the adequacy of some 
corrective actions, or if evaluating the corrective actions remotely would unreasonably 
extend the duration of the remote interactive evaluation. 
  Provide verbal updates to the facility on observations and outstanding issues, whenever 
feasible. 
FDA will not issue a Form FDA 482, Notice of Inspection, to announce or open a remote 
interactive evaluation. 
 
A.  Technological Requirements 
 
The quality of the remote connection (e.g., connectivity, image quality, cameras used) should be 
adequate for FDA to remotely review, observe, examine, and evaluate the information requested. 
To the extent practicable, technologies employed also should allow access for clear and stable 
remote viewing and evaluation of operations at the facility, as necessary (e.g., aseptic practices, 
equipment cleaning and set up, material weighing and dispensing, instrument set up, sampling, 
testing). FDA understands that there may be temporary connection issues during the virtual 
interaction, and we expect either party to resolve the issue in a timely manner. 
 
For security reasons, FDA will use its own IT platforms and equipment12 to host virtual 
interactions during remote interactive evaluations (e.g., videoconferences, livestreaming video of 
the facility and operations in the facility). FDA currently uses the following conferencing 
platforms: 
  FDA Microsoft Teams 
  FDA Zoom for Government 
  FDA Adobe Connect 
 
 
 
10 FDA requests, including requests for records, during a remote interactive evaluation are considered voluntary 
unless a section 704(a)(4) request is sent to the facility.  
11 For example, for a remote interactive evaluation supporting a pending biologics license application, FDA usually 
will expect a facility to provide for livestream video of the manufacturing operations described in the application. 
12 FDA is not able to supply equipment to a facility to enable FDAs remote interactive evaluation. Additionally, 
FDA is not able to accept equipment or devices from a facility for our use in conducting a remote interactive 
evaluation. 
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B.  Remote Interactive Evaluation of Documents and Records 
 
FDA will usually request and review documents and other information in advance of a remote 
interactive evaluation13 to ensure the livestream interactions are as efficient as possible. 
However, we may request additional documents and other information, including video 
recordings, at any time during the remote interactive evaluation to address questions and to 
explain observations. Documents and other information requested during a remote interactive 
evaluation should be provided within a reasonable timeframe. 
 
FDA expects all documents provided during the remote interactive evaluation in response to 
FDAs request to be provided in electronic format or accessible by screen sharing during a live 
interaction so that the documents can be assessed efficiently. FDA will provide a secure means to 
send requested information during a remote interactive evaluation. For electronic documents and 
other information, facilities should identify any limitations and ensure that encrypted and 
password-protected files can be accessed by FDA. Documents submitted during a remote 
interactive evaluation should be in English. However, if translation is needed during a livestream 
interaction, the facility may need to provide a translator. 
 
FDA recognizes that some facilities maintain documents in paper format and not all electronic 
systems will be accessible for direct viewing. Thus, when such a facility agrees to participate in a 
remote interactive evaluation, they should consider taking steps to enable FDAs remote viewing 
and verification of the facilitys documents, procedures, and electronic systems. Requested 
documents maintained in paper format should be scanned as searchable Portable Document 
Format (PDF) files when possible. 
 
 
V.  CONCLUDING A REMOTE INTERACTIVE EVALUATION 
 
Upon completion of a remote interactive evaluation, FDA will have a closeout meeting with the 
facilitys management. During this meeting, FDA will usually present a written list of 
observations, if any, and describe and discuss any observations in sufficient detail to enable 
understanding and foster an appropriate response.14,15 This written list of observations will not be 
a final Agency action or decision. FDA will not issue a Form FDA 483, Inspectional 
Observations. As with an inspection, FDA encourages facilities to respond during the discussion 
and/or provide responses in writing to the observations within 15 U.S. business days. 
 
 
13 Generally, such requests for records or other information prior to the remote interactive evaluation will be made 
under section 704(a)(4) of the FD&C Act. 
14 If the remote interactive evaluation, including the review of any records before or during the evaluation, is 
intended to supplement a scheduled inspection, then FDA usually will combine any observations from the remote 
interactive evaluation(s) into a single written list of observations issued at the close of the inspection, which would 
be issued on a Form FDA 483, Inspectional Observations. 
15 See the FDA draft guidance for industry Conducting Remote Regulatory Assessments  Questions and Answers 
(July 2022) for further information on processes related to the completion of a remote regulatory assessment. When 
final, this guidance will represent FDAs current thinking on this topic. We update guidances 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. 
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Depending on the purpose and outcome of the remote interactive evaluation, the information and 
documentation collected may be used to, among other regulatory purposes: 
 
  Support FDAs assessment of pending applications, including whether to approve an 
application 
  Preclude the need for an inspection in follow-up to a reported concern or defect 
  Support a regulatory meeting, warning letter, import alert, recall activities, or 
enforcement action 
  Rank or prioritize a facility for an inspection, particularly a surveillance CGMP 
inspection 
  Justify a follow-up or compliance inspection or any other surveillance activity 
 
After the remote interactive evaluation concludes, FDA will generally provide a copy of the final 
remote interactive evaluation report to the facility. A remote interactive evaluation report and 
any written list of observations may be subject to a disclosure request under the Freedom of 
Information Act. 
 
If FDA determines that an inspection will be necessary based on the outcome of the remote 
interactive evaluation, we intend to use the information obtained from the remote interactive 
evaluation to prepare for and conduct the inspection. 
 
 
VI.  TIMEFRAMES FOLLOWING COMPLETION OF A REMOTE INTERACTIVE 
EVALUATION 
 
In general, the use of remote interactive evaluations should not affect FDAs ability to operate 
within normal timeframes (i.e., in a manner similar to an inspection). FDA may use information 
gained from remote interactive evaluations to meet user fee commitments and to update relevant 
internal databases. 
 
A.  Response Timeframes for Remote Interactive Evaluations Generally 
 
FDA encourages establishments to provide responses in writing to the observations made during 
the RIE within fifteen (15) U.S. business days. Any responses or corrective actions submitted to 
FDA during that timeframe in response to the issues identified during the RIE generally will be 
considered before further Agency action or decision. 
  
B.  Response Timeframes for Remote Interactive Evaluations in Support of 
Preapproval and Prelicense Inspection Programs 
 
FDA encourages establishments to provide responses in writing to the observations made during 
the RIE within fifteen (15) U.S. business days. Any responses or corrective actions submitted to 
FDA during that timeframe in response to the issues identified during the RIE generally will be 
considered before further Agency action or decision. 
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FDA may defer consideration of responses or corrective actions in the current application review 
cycle if received after 15 U.S. business days. Deferred responses or corrective actions will be 
considered in the next application user fee cycle if the application receives a complete response 
action and the facility requires reevaluation. 
  10