American Regent Inc.
FDA inspection history in Hilliard, Ohio, 2019 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Hilliard, Ohio.
- 2023One Form 483, at Hilliard, Ohio.
- 2023The longest 483 on file: 2 observations over 3 pages at Hilliard, Ohio.
Cited most
Across all American Regent observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 314.81(b)(1)(ii)Other postmarketing reports1
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
Hilliard, Ohio
Two Form 483s · 2019 to 2023 · 4 observations
Latest: Form 483, Jul 20, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-07-20 | 483 Form 483 | Hilliard, Ohio | 2 | $99 |
| 2019-03-08 | 483 Form 483 | Hilliard, Ohio | 2 | $99 |
Investigators on these documents
FEI number 3005761472 · most recent document Jul 20, 2023
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 20, 2023.
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 20, 2023, for the site in Hilliard, 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 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.