FDA Remote Regulatory Assessment Request? A Guide for Supplement Makers

If your dietary supplement company has received a request from FDA for a Remote Regulatory Assessment, start with what it is. FDA's final guidance, Conducting Remote Regulatory Assessments: Questions and Answers, is dated June 2025 on its cover. It defines an RRA as "an examination of an FDA-regulated establishment and/or its records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements." It also says plainly that "an RRA is not an inspection" under the inspection sections of the FD&C Act. For a 21 CFR Part 111 manufacturer that does not import, the RRA FDA can ask for is usually a voluntary one. You can decline it, but the guidance makes clear that declining does not end FDA's interest in your facility.

Is an RRA an inspection?

No, with one exception. The guidance says an RRA "is not an inspection under sections 704(a)(1) or 704(a)(5) of the FD&C Act," and FDA says it does not intend to issue a Form FDA 482, Notice of Inspection, for one, whether the RRA is mandatory or voluntary. The exception is a records request under the Foreign Supplier Verification Program (FSVP), which the guidance says functions as an inspection. That matters if your company also imports ingredients or finished product and is an FSVP importer.

Do you have to say yes?

That depends on which kind of RRA it is, and the guidance describes three.

For FSVP requests, the guidance says "FDA generally expects FSVP records to be sent within 72 hours of the request."

A supplement maker that also manufactures OTC drugs is a drug establishment, and a supplement company that imports may be an FSVP importer, so read the request carefully for the authority FDA cites. The guidance also notes that section 704(a)(4) and FSVP "are not necessarily the only types of mandatory RRAs for which FDA has authority."

For a voluntary RRA, the guidance says "FDA will not take enforcement action solely based on an establishment declining a voluntary RRA." It also says FDA "may consider other activities… such as an inspection." And it is explicit that "an establishment may not opt out of an FDA inspection."

In my view, the practical decision is less about whether FDA will see your records and more about whether you would rather show them remotely, on a timeline you help set, or in person during an inspection.

What happens once you agree?

The guidance describes a process that is more collaborative than most firms expect.

• The request. FDA contacts your establishment's point of contact by email or phone. Where practicable, it seeks consent in writing and tells you "the purpose and planned scope of the RRA and of the right to refuse consent."
• Timing. For a voluntary RRA, "FDA may suggest timeframes." If you need more time, the guidance asks you to tell the FDA point of contact as soon as possible.
• Format. Records "generally should be submitted in an electronic format," and paper records should be scanned "as searchable Portable Document Format (PDF) files." FDA says it intends to identify and use a secure means of transfer.
• Language. FDA may ask for records in English or with an English translation, together with "a verification that the translation is complete and accurate."
• Video. An RRA can include "livestream and/or pre-recorded video." FDA says it generally does not intend to record a livestream and will tell you first if it does. If the video is not good enough, FDA may end the RRA and consider an inspection.
• Confidentiality. FDA says it "will follow federal laws and regulations governing the confidentiality and retention of records."

What to check before you send any records

Part 111 already requires you to keep its records "readily available during the retention period for inspection and copying by FDA when requested" (21 CFR 111.610). So the question in an RRA is rarely whether a record exists. It is whether the record is complete, legible and tells a consistent story. Before anything goes to FDA, I would check:

1. The authority and scope in writing. Confirm which kind of RRA this is, what FDA asked for, and who your single point of contact on each side is.
2. Each requested record against the rule it answers. Specifications (§111.70), master manufacturing records (§111.205), batch production records (§111.255) and complaint records (§111.570) are common places for gaps to show.
3. Completeness and legibility. Missing pages, unsigned entries and unreadable scans read worse remotely than on a conference-room table, because nobody is there to explain them.
4. Translations. Any record not in English needs a translation and a statement that it is complete and accurate.
5. The timeline. If FDA's suggested timeframe does not fit the volume of records, ask for more time early rather than sending an incomplete set.
6. A log of what you sent. Keep a list of every document provided, the version and the date, so your response to any observation can point to the same record FDA saw.

After the RRA: observations and your response

At the end, "FDA may have a closeout meeting" and "may present a written list of RRA observations." FDA "does not intend to issue a Form FDA 483" for an RRA, and it asks for a written response "within fifteen (15) U.S. business days."

Do not treat the absence of a 483 as the absence of risk. The guidance says the observation list "is not a final Agency action." It also says that after an RRA "FDA may conduct an inspection or… an enforcement action."

RRA findings can support "a regulatory meeting, warning letter, import action, recall activity" and help FDA "determine the priority of establishments for inspection." Observations can also appear on a later Form 483 once an investigator confirms them on site, and the list may be released under the Freedom of Information Act.

A good response answers each observation on its own. It says what you found when you investigated, what you corrected right away, what you changed so it does not happen again, and when each change will be finished, with evidence attached. Our warning letter response playbook walks through the same structure, and it works for RRA observations too.

As of September 2026, the June 2025 final guidance is FDA's current statement on how it conducts RRAs. It does not mention dietary supplements or Part 111 by name, so read it through the lens of whether your company is only a Part 111 manufacturer or also an importer or a drug establishment.

How Certify Consulting Group helps

Certify Consulting Group is a regulatory compliance consultant for dietary supplement manufacturers, and FDA Remote Regulatory Assessments are part of that work. When a request arrives, I confirm what kind it is and review the records against 21 CFR 111 before they go to FDA. I prepare your team for any video portion and draft the written response to the observations within FDA's 15-business-day window. Start with our dietary supplement consultants page or book a call.