American Regent, Inc.
Form 483 issued July 19, 2024 · Brea, California
- Inspection
- Jan 15 – Jul 19, 2024
- Investigator
- Rowena S. Nguyen
- Observations
- 5
- Pages
- 2
- FEI number
- 3011148804
In short: On July 19, 2024, FDA issued a Form 483 with 5 observations to American Regent, Inc. in Brea, California (FEI 3011148804) after an inspection that ran Jan 15 – Jul 19, 2024. The investigator was Rowena S. Nguyen. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
5 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (5×)
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
Observation 2: scanned text, readable in the full document.
- 03
Sour firm uses UN} WS to…
- 04
Yaw firm uses the followin excel forms te Am late est vesults for Pacli axel…
This inspection in context
Rowena S. Nguyen
12 documents · 2022–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in California.
The firmAmerican Regent, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Regent, Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected American Regent, Inc.?
Rowena S. Nguyen is named on this Form 483, for the inspection of Jan 15 – Jul 19, 2024. Each investigator has a profile showing what they cite most.
When was American Regent, Inc. inspected by FDA?
The inspection ran Jan 15 – Jul 19, 2024, and the Form 483 is dated July 19, 2024.
How do I get the full Form 483 for American Regent, 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.