American Regent, Inc.
FDA inspection history in New Albany, Ohio, 2022
- 2
- Form 483s
Every document, by year
- Form 483
2022: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2022Two Form 483s, at New Albany, Ohio.
- 2022The longest 483 on file: 3 observations over 3 pages at New Albany, Ohio.
Cited most
Across all American Regent observations on file
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.25Personnel 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
New Albany, Ohio
Two Form 483s · 2022 · 4 observations
Latest: Form 483, Dec 9, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-12-09 | 483 Form 483 | New Albany, Ohio | 3 | $99 |
| 2022-09-30 | 483 Form 483 | New Albany, Ohio | 1 | $99 |
Investigators on these documents
FEI number 3010209784 · most recent document Dec 9, 2022
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 Dec 9, 2022.
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 Dec 9, 2022, for the site in New Albany, Ohio.
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 (Control of microbiological contamination), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.22(d) (Responsibilities of quality control unit), 1 time.