Revance Therapeutics, Inc.
FDA inspection history in Newark, California, 2021 to 2022
- 3
- Form 483s
- 1
- EIR
Every document, by year
- Form 483
- EIR
2021: two Form 483s and one inspection report; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–22Three Form 483s and one inspection report, at Newark, California.
- 2021The longest 483 on file: 5 observations over 3 pages at Newark, California.
Cited most
Across all Revance Therapeutics observations on file
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.103Calculation of yield2
- 21 CFR 211.160General requirements2
- 21 CFR 211.113Control of microbiological contamination1
The complete Revance Therapeutics file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Newark, California
Three Form 483s and one inspection report · 2021 to 2022 · 13 observations
Latest: Form 483, Jul 15, 2022 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-07-15 | 483 Form 483 | Newark, California | 3 | $99 |
| 2021-10-12 | 483 Form 483 | Newark, California | 5 | $99 |
| 2021-07-02 | EIR EIR | Newark, California | — | $550 |
| 2021-07-02 | 483 Form 483 | Newark, California | 5 | $99 |
Investigators on these documents
Carla J. Lundi (2)Joao Pedras-Vasconcelos (1)Patricia F. Hughes (1)Sarah Johnson (1)Virginia A. Carroll (1)
FEI number 3007772056 · most recent document Jul 15, 2022
About Revance Therapeutics, Inc.
How many FDA Form 483s has Revance Therapeutics, Inc. received?
FDA Intel has 3 Form 483s on file for Revance Therapeutics, Inc.; the most recent is dated Jul 15, 2022.
When was Revance Therapeutics, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Revance Therapeutics, Inc. is a Form 483 dated Jul 15, 2022, for the site in Newark, California.
What did FDA cite at Revance Therapeutics, Inc.?
The regulations cited most in the observations on file for Revance Therapeutics, Inc. are 21 CFR 211.22 (Responsibilities of quality control unit), 4 times; 21 CFR 211.100 (Written procedures; deviations), 3 times; 21 CFR 211.103 (Calculation of yield), 2 times.