Free FDA Registration Verification — Check Your Status

Verify FDA Registration — Frequently Asked Questions

How do I check whether my FDA registration is still active?

Check that the registration exists, that it was renewed in the last required window, and that the facility details and U.S. agent on file still match reality. Any one of those can be wrong while the others look fine, which is why a lapse often goes unnoticed until a shipment is held.

Why would a registration be treated as mismatched?

Usually because something changed and the filing did not. A moved facility, a renamed legal entity, a facility identifier that no longer matches, or a U.S. agent who no longer agrees to serve. Under 21 CFR 1.231 the agent must confirm agreement to serve.

What does it take to restore a lapsed registration?

A new or corrected filing, plus reconciling whatever drifted — facility details, the identifier, the U.S. agent appointment. Under 21 CFR 1.241 failure to register or renew is a prohibited act, so the priority is getting the registration active before the next shipment moves.

Know your renewal cycle

Food, Beverage & Supplements

Renew between October 1 and December 31 of every even-numbered year — 2026 is a renewal year. Miss it and FDA considers the registration expired.21 CFR 1.230

Drugs / OTC

Establishment registration renews every year, October 1 – December 31, with drug listing certification alongside.21 CFR 207.29

Medical Devices

Establishment registration and listing renew annually in the same October – December window.21 CFR Part 807

Frequently asked questions

Why can’t I check my FDA food facility registration online myself?

FDA does not publish the food facility registration list — it is exempt from public disclosure under 21 CFR 1.243. That means there is no public database to search, and verification requires a regulatory check.

What can make an FDA registration invalid?

Common causes include a missed renewal window (FDA treats an unrenewed registration as expired), a change of ownership without re-registration, a foreign facility’s U.S. Agent not accepting the designation, or a missing or mismatched unique facility identifier (DUNS).

What do I receive from the free verification?

Axentra’s regulatory team checks your registration status and emails you the result. If anything is invalid or at risk — a lapsed renewal, a U.S. Agent gap, mismatched details — we tell you exactly what to fix and how.

Is the verification really free?

Yes — verification is free with no obligation. If remediation is needed, Axentra’s published flat fees apply, such as the Market Access Bundle at $299 per facility per year covering U.S. Agent service and FDA registration.