American Regent, Inc.
FDA inspection history in Brea, California, 2019 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Brea, California.
- 2019The longest 483 on file: 8 observations over 9 pages at Brea, California.
- 2024One Form 483, at Brea, California.
Cited most
Across all American Regent observations on file
- 21 CFR 211.68Automatic, mechanical, and electronic equipment6
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.186Master production and control records1
- 21 CFR 211.188Batch production and control records1
The complete American Regent file.
All 2 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
Brea, California
Two Form 483s · 2019 to 2024 · 9 observations
Latest: Form 483, Jul 19, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-19 | 483 Form 483 | Brea, California | 1 | $99 |
| 2019-01-25 | 483 Form 483 | Brea, California | 8 | $99 |
Investigators on these documents
FEI number 3011148804 · most recent document Jul 19, 2024
About American Regent, Inc.
How many FDA Form 483s has American Regent, Inc. received?
FDA Intel has 2 Form 483s on file for American Regent, Inc.; the most recent is dated Jul 19, 2024.
When was American Regent, Inc. last inspected by FDA?
The most recent FDA inspection document on file for American Regent, Inc. is a Form 483 dated Jul 19, 2024, for the site in Brea, California.
What did FDA cite at American Regent, Inc.?
The regulations cited most in the observations on file for American Regent, Inc. are 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 6 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.165 (Testing and release for distribution), 1 time.