Revance Therapeutics, Inc.
Form 483 issued July 2, 2021 · Newark, California
- Inspection
- Jun 21 – Jul 2, 2021
- Investigator
- Carla J. Lundi
- Observations
- 5
- Pages
- 3
- FEI number
- 3007772056
In short: On July 2, 2021, FDA issued a Form 483 with 5 observations to Revance Therapeutics, Inc. in Newark, California (FEI 3007772056) after an inspection that ran Jun 21 – Jul 2, 2021. The investigator was Carla J. Lundi. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 3 of 5 observations.
Most cited: 21 CFR 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
The current manufacturing process is not the…
- 03
The firm’s Quality Unit lacks the responsibility and authority for the control, review, and approval of…
- 04
Actual yield and percentages of theoretical yield, indicators of process performance, are not determined at the…
This inspection in context
Carla J. Lundi
9 documents · 2009–2021
Cites 211.160 (general requirements) 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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Revance Therapeutics, Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Revance Therapeutics, Inc.?
Carla J. Lundi is named on this Form 483, for the inspection of Jun 21 – Jul 2, 2021. Each investigator has a profile showing what they cite most.
When was Revance Therapeutics, Inc. inspected by FDA?
The inspection ran Jun 21 – Jul 2, 2021, and the Form 483 is dated July 2, 2021.
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.