Amneal Complex Products Research LLC
FDA inspection history in Bridgewater, New Jersey, 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 Bridgewater, New Jersey.
- 2018The longest 483 on file: 2 observations over 2 pages at Bridgewater, New Jersey.
- 2024One Form 483, at Bridgewater, New Jersey.
Cited most
Across all Amneal Complex Products Research observations on file
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
The complete Amneal Complex Products Research 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
Bridgewater, New Jersey
Two Form 483s · 2018 to 2024 · 3 observations
Latest: Form 483, May 17, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-05-17 | 483 Form 483 | Bridgewater, New Jersey | 1 | $99 |
| 2018-04-18 | 483 Form 483 | Bridgewater, New Jersey | 2 | $99 |
Investigators on these documents
FEI number 3010529997 · most recent document May 17, 2024
About Amneal Complex Products Research LLC
How many FDA Form 483s has Amneal Complex Products Research LLC received?
FDA Intel has 2 Form 483s on file for Amneal Complex Products Research LLC; the most recent is dated May 17, 2024.
When was Amneal Complex Products Research LLC last inspected by FDA?
The most recent FDA inspection document on file for Amneal Complex Products Research LLC is a Form 483 dated May 17, 2024, for the site in Bridgewater, New Jersey.
What did FDA cite at Amneal Complex Products Research LLC?
The regulations cited most in the observations on file for Amneal Complex Products Research LLC are 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 1 time.