Revance Therapeutics, Inc.
Form 483 issued July 15, 2022 · Newark, California
- Inspection
- Jul 11 – Jul 15, 2022
- Investigators
- Patricia F. Hughes· Sarah Johnson· Virginia A. Carroll
- Observations
- 3
- Pages
- 1
- FEI number
- 3007772056
In short: On July 15, 2022, FDA issued a Form 483 with 3 observations to Revance Therapeutics, Inc. in Newark, California (FEI 3007772056) after an inspection that ran Jul 11 – Jul 15, 2022. The investigators were Patricia F. Hughes, Sarah Johnson and Virginia A. Carroll. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
2 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (2×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Deviations are not always initiated according to SOP_QA_0042…
- 02
SOP_EQ_0419, Operation and Cleaning of (b)(4) does not contain adequate information to…
- 03
Cell bank storage facility information is…
This inspection in context
Patricia F. Hughes
2 documents · 2022–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in California.
The firmRevance Therapeutics, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Revance Therapeutics, Inc.?
FDA listed 3 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Revance Therapeutics, Inc.?
Patricia F. Hughes, Sarah Johnson and Virginia A. Carroll are named on this Form 483, for the inspection of Jul 11 – Jul 15, 2022. Each investigator has a profile showing what they cite most.
When was Revance Therapeutics, Inc. inspected by FDA?
The inspection ran Jul 11 – Jul 15, 2022, and the Form 483 is dated July 15, 2022.
How do I get the full Form 483 for Revance Therapeutics, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.