Revance Therapeutics, Inc FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Revance Therapeutics, Inc has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Revance Therapeutics, Inc" is on file. FDA has published 2 Form 483s for Revance Therapeutics, Inc.

What these totals cover: FDA records filed under the name "Revance Therapeutics, Inc" and its spelling variant "Revance Therapeutics".

Latest inspection
May 1, 2025 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Revance Therapeutics, Inc Form 483s

2 Form 483s published by FDA.

DateDocumentFEI
Jul 15, 20224833007772056
Jul 2, 20214833007772056

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

2 inspections from Feb 27, 2025 to May 1, 2025.

DateSiteProductClassificationFEI
May 1, 2025Moffett Field, CADrugsNo Action Indicated (NAI)3019604545
Feb 27, 2025Newark, CADrugsVoluntary Action Indicated (VAI)3007772056
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3019604545Moffett Field, CA1May 1, 2025
FEI 3007772056Newark, CA1Feb 27, 2025

Revance Therapeutics, Inc and the FDA: common questions

Has Revance Therapeutics, Inc received an FDA warning letter?

No FDA warning letter addressed to the name "Revance Therapeutics, Inc" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Revance Therapeutics, Inc received an FDA Form 483?

FDA has published 2 Form 483s for Revance Therapeutics, Inc in its reading room, the most recent dated Jul 15, 2022. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Revance Therapeutics, Inc?

The most recent FDA inspection on file ended May 1, 2025 at Moffett Field, CA and was classified NAI. FDA has 2 inspections of Revance Therapeutics, Inc on file.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.