American Regent, Inc.
FDA inspection history in Shirley, New York, 2018 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Shirley, New York.
- 2024One Form 483, at Shirley, New York.
- 2024The longest 483 on file: 7 observations over 10 pages at Shirley, New York.
Cited most
Across all American Regent observations on file
- 21 CFR 211.113(b)Control of microbiological contamination2
- 21 CFR 211.42(c)(10)(iii)Design and construction features2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.142(b)Warehousing procedures1
- 21 CFR 211.25(a)Personnel qualifications1
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
Shirley, New York
Two Form 483s · 2018 to 2024 · 9 observations
Latest: Form 483, Apr 24, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-04-24 | 483 Form 483 | Shirley, New York | 7 | $99 |
| 2018-04-11 | 483 Form 483 | Shirley, New York | 2 | $99 |
Investigators on these documents
FEI number 2410375 · most recent document Apr 24, 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 Apr 24, 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 Apr 24, 2024, for the site in Shirley, New York.
What did FDA cite at American Regent, Inc.?
The regulations cited most in the observations on file for American Regent, Inc. are 21 CFR 211.113(b) (Control of microbiological contamination), 2 times; 21 CFR 211.42(c)(10)(iii) (Design and construction features), 2 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time.