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Revance Therapeutics, Inc. FDA Inspection Record

FEI 3007772056 · Inspections, Form 483s, warning letters and import refusals

Revance Therapeutics, Inc. is an FDA-registered facility (FEI 3007772056) located in Newark, CA, US. Registered operations: ANALYSIS; API MANUFACTURE; MANUFACTURE. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Feb 27, 2025: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Form 483 and inspection documents
3 in FDA's reading room
Import refusals
4

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Feb 27, 2025Voluntary Action Indicated (VAI)Scientifically sound laboratory controls (21 CFR 211.160(b))

Form 483s and inspection documents

  • 483 on FDA.gov
    Inspection Jul 11, 2022 to Jul 15, 2022 (dates printed on the document). FDA listing date Jul 15, 2022. Published by FDA Jun 20, 2025.
  • 483 on FDA.gov
    Issued Jul 2, 2021 (dates printed on the document). FDA listing date Jul 2, 2021. Published by FDA Oct 12, 2021.
  • Establishment Inspection Report (EIR) on FDA.gov
    FDA listing date Jul 2, 2021, which is not always the inspection or issue date. Published by FDA Nov 18, 2021.

Facility details

Company
Revance Therapeutics, Inc
Location
Newark, CA (US)
Registration Expires
Dec 31, 2027
Operations
ANALYSIS; API MANUFACTURE; MANUFACTURE
Source
both

Import refusals

FDA data resources

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