Drug factory · FDA FEI 3007772056
Revance Therapeutics, Inc.
7555 Gateway Boulevard, Newark, CA, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 27, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2025: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Botulinum Toxin Type A | Makes it, makes the active ingredient and tests it | Revance Therapeutics, Inc. | 72960-112 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 27, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Feb 27, 2025 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that conform to appropriate standards of identity, strength, quality and purity.
Registered with FDA for: analysis; api manufacture; manufacture.