Regulatory Remote Assessments - Questions & Answers in a Nutshell

Introduction on Remote Regulatory Assessments by the U.S. FDA 

The U.S. FDA published the final version of a Guidance for Industry on conducting remote regulatory assessments in June of 2025. Remote Regulatory Assessments (or in short: RRA's) were utilized during the COVID-19 pandemic to allow the U.S. FDA to perform its inspection duties whilst travel restrictions were in place.  

Remote Regulatory Assessments does not translate to a singular form of performing a remote assessment but could also mean (for example):  

• A remote interactive evaluation,
• A remote record review,

Although the exact method may vary, the unifying factor is that all RRA’s are completely remote. 

Following the success of RRA’s and the subsequent questions that were received from the industry the U.S. FDA released this guidance. 

Why was this guidance published? 

The main purpose of this guidance is to increase transparency in why / how RRA’s are utilized and to increase consistency in the way RRA’s are conducted, how companies can respond to an RRA request and how the U.S. FDA evaluates a company’s response and timeliness. 

Who may be subject to an RRA? 

Mandatory RRAs 

Mandatory RRAs include those conducted for: (1) establishments that are subject to section 704(a)(4) of the FD&C Act; 12 and (2) importers, as defined in 21 CFR 1.500, that are subject to FSVP under section 805 of the FD&C Act and to the records review requirements in 21 CFR 1.510(b)(3) or 1.512(b)(5)(ii)(C), as applicable. 

In plain English, the following categories of companies may be subjected to mandatory RRAs: 

• U.S.-based food production or processing facilities under FDA oversight.
• U.S. food importers responsible for foreign supplier safety(FSVP).

Does this mean that pharmaceutical manufacturers/importers/distributors are excluded from mandatory RRA’s? In this version of the guidance, pharma companies can receive RRA’s but they are not named in the mandatory RRA section because no statute forces FDA to do so. 

Voluntary RRAs 

If an RRA is not mandated, or the FDA chooses not to use it, any other establishment under the jurisdiction of the U.S. FDA may be requested to participate in a voluntary RRA. 

Voluntary means that companies may decline the RRA. This means that there will be no punitive action. Declining a voluntary RRA is, however, not free of consequences.  

As a result of a declined voluntary RRA: 

• The likelihood of a mandatory FDA inspection increases, it may come earlier than expected, be more comprehensive and could be less flexible in timing.
• Reviews may take longer as the FDA has less information to baseit’sdecision on.
• Product approvals or submissions may be delayed.
• The FDA will view your site as “unassessed” for a longerperiod of time, if theycan’tperform a RRA andcan’tinspect in person for whatever reason then they simply lack visibility.

Declining a voluntary RRA won’t get you in trouble, but it often leads to slower reviews, more uncertainty, and a higher chance of a full FDA inspection instead, which is more disruptive. 

RRA – Quick Facts 

What is an RRA? 

A Remote Regulatory Assessment (RRA) is an FDA examination conducted remotely to support regulatory oversight and decision-making. 

Who may be subject to an RRA? 

Any FDA-regulated establishment. 
RRAs may be: 

• Mandatory (mainly certainfood establishments/importers), or
• Voluntary (e.g. pharma, biologics, devices).

Do RRAs replace inspections or other oversight tools? 

No. RRAs do not replace inspections or other established ways FDA collects information. 

Is an RRA an FDA inspection? 

No. An RRA is not an inspection under section 704 of the FD&C Act and: 

• Is conducted by designated FDA staff
• Is performed within a reasonable timeframe
• Does not result in a Form 483

When may FDA initiate or request an RRA? 

FDA may request an RRA when it: 

• Cannot easily conduct an on-site inspection (e.g. travel restrictions)
• Needs information to support regulatory decisions
• Determinesan RRA wouldassistits oversight responsibilities

Will FDA use RRAs during or as part of an inspection? 

No. RRAs are separate from inspections and are not conducted as part of one. 

What are the benefits of an RRA? 

RRAs can: 

• Improve inspection and regulatory preparedness
• Reduce time and resource burden
• Support regulatory decisions
• Provide additional operational insight
• Help verify corrective actions

Expectations During an RRA 

How may FDA request an RRA? 

FDA may: 

• Contact the establishment’s Point of Contact (PoC)
• Request records using FDA Form 4003
• Use RRAs to support PAIs and PLIs
• Request documents in advance
• Provide sufficiently detailed record requests
• Confirm receipt of submitted materials 

What should an establishment expect during an RRA? 

An RRA may include: 

• Requests for documents and records
• Virtual meetings with FDA
• Livestream or pre-recorded video of operations
• Remote review of electronic systems
• Discussion of observations with FDA

Are there consequences for declining a voluntary RRA? 

Yes, indirectly. Declining is allowed, but FDA may: 

• Schedule an on-site inspection instead
• Take longer to assess the establishment
• Delay regulatory or application decisions
• An establishment cannot decline an FDA inspection.

Are there technological expectations? 

Yes. Establishments should ensure: 

• Adequate hardwareandconnectivity
• Secure systems
• Sufficientimageandvideo quality
• Camera resolution suitable for remote viewing
  All to support FDA’s oversight activities.

Requests and Records 

What records may FDA request during an RRA? 

FDA may request: 

• Facility summaries and overviews
• Batch and quality control records
• SOPs
• Read-only access to electronic databases

How may FDA use information gathered during an RRA? 

Information may be used to: 

• Support marketing application reviews
• Assess product compliance
• Decide whether an inspection is needed
• Support regulatory actions (e.g. warning letters)
• Support import actions or recall activities

What is the timeframe for submitting records? 

Timeframes are: 

• Consistent with applicable legal authorities
• Communicated by FDA as part of the request

How should records be provided to FDA? 

Records should be: 

• Submitted electronically
• Readable and accessible
• Not encrypted or password-protected
• Scanned to PDF if paper-based
• Provided in English (or verified English translation)

Completion of an RRA 

What happens when an RRA is completed? 

FDA may: 

• Hold a close-out meeting with management
• Present a written list of observations

FDA: 

• Encourages discussion during the close-out meeting
• Encourages written responses within 15 business days
• May use RRA outcomes to support future actions or decisions
• Intends to prepare an internal RRA report
  An RRA is not a final Agency decision.

Additional reference 

RRAs should be read in conjunction with PIC/S guidance on Remote Assessments.