Guidance Breakdown: Conducting Remote Regulatory Assessments (Q&As for Industry)
Remote regulatory assessments are now a permanent FDA oversight tool. (But don't call them an "inspection!")
This guidance breakdown is available in full to paid subscribers. Only paid subscribers get regular full access to our guidance breakdowns and other analyses. If you’re not already a paid subscriber, you can upgrade here.
The FDA just finalized its guidance “Conducting Remote Regulatory Assessments – Questions & Answers.”
The COVID-era experience demonstrated that real-time video walk-throughs, remote record reviews, and other off-site activities can keep regulatory oversight moving even when travel is stalled.
The new Q&A locks RRAs in as a standing tool—voluntary in many cases, mandatory in others—across every FDA Center and product class, from drugs and biologics to devices, tobacco, foods and veterinary products.
We distilled the Q&As below.
What counts as an RRA?
An RRA is an examination of an FDA-regulated establishment and/or its records, conducted entirely off-site, to evaluate compliance with the FD&C Act or other laws FDA enforces.
“Remote interactive evaluations,” “remote record reviews,” and similar activities all fall under the RRA umbrella.
RRAs are not inspections under §704(a)(1); no Form 482 is issued, and a Form 483 will only appear later if FDA confirms observations during a separate on-site inspection.
Who can be tapped—and do you have to say yes?
The guidance clarifies the distinction between mandatory and voluntary RRAs.
Mandatory RRAs: Drug and device manufacturers and BIMO sites can be compelled to provide any records FDA may inspect (§704(a)(4)). Food importers must supply Foreign Supplier Verification Program (FSVP) records within 72 hours (§805). Declining may trigger prohibited-act charges or import refusal.
Voluntary RRAs: Any FDA-regulated facility—domestic or foreign—may be invited to a voluntary RRA. You may refuse, but the FDA can respond with an inspection or other enforcement tools based on risk and resource needs.
When will the FDA lean on RRAs?
The agency makes this pretty clear:
To verify corrective actions after an inspection.
To support a time-sensitive application decision when an on-site visit is impractical.
When travel is blocked by a public-health emergency, natural disaster or geopolitical constraint.
As triage: determining whether a full inspection should be scheduled sooner, later, or at all.
FDA stresses that RRAs will never run simultaneously with an on-site inspection but can precede or follow one. Observations noted remotely must be confirmed in person before they appear on a 483.
What actually happens during an RRA?
Expect a tailored mix of:
Record requests—anything FDA could inspect on-site, plus read-only access to electronic systems.
Interactive sessions—screen-sharing walkthroughs, virtual interviews with SMEs, livestream or prerecorded video of operations (e.g., aseptic line set-up).
Rolling feedback—investigators aim to discuss emerging observations so you can clarify or correct in real time.
Your technological capability must be “adequate” for the FDA to observe and evaluate; poor video quality or network security gaps can prompt the FDA to halt the RRA and default to other oversight actions.
Records: what, how, and how fast?
Long story short:
Scope: Batch documentation, deviation investigations, validation packages, SOPs, database queries—essentially whatever underpins CGMP, QSR or FSVP compliance.
Format: Prefer searchable PDFs or read-only system access. Paper must be scanned. English or verified English translation may be required.
Timeframe:
§704(a)(4) drug/device/BIMO requests: typically 15 calendar days (30 days if translation needed), but shorter windows are possible for goal-date pressures.
FSVP importers: within 72 hours.
Failure to meet a mandatory deadline can constitute a prohibited act or lead to import refusal.
Close-out and follow-up
The FDA may hold a virtual close-out meeting and provide a written list of RRA observations. Responses submitted within 15 business days are considered before further action. No Form 483 is issued, but the narrative report—minus redactions—can become public under FOIA.
Remote findings can:
Satisfy the FDA that no further action is needed.
Trigger warning letters, import alerts or other enforcement.
Be folded into risk models that decide your next inspection date.
A few recommended action items from us
Here are detailed steps we recommend teams consider to operationalize this guidance:
Stand up a “digital front desk.” Create a dedicated RRA SharePoint or secure portal with indexed, OCR-searchable PDFs of:
last three years of batch records, deviation/CAPA files, validation/qualification reports, and SOPs;
site-master diagram, quality-system descriptions, and management review minutes.
Format and language matter: FDA can require English or certified translations, and scans must be legible and searchable.
Script a 24-hour triage workflow for mandatory record calls. Drug, device, and BIMO sites get as little as 15 calendar days (30 if translation required); FSVP importers just 72 hours. Pre-assign:
a regulatory liaison to log the request,
IT support to provision read-only system access,
a translator pool for non-English records,
QA reviewers to double-check sensitive redactions before release.