Amneal Pharmaceuticals, LLC
FDA inspection history in Branchburg, New Jersey, 2019 to 2022
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Branchburg, New Jersey.
- 2019The longest 483 on file: 3 observations over 5 pages at Branchburg, New Jersey.
- 2022One Form 483, at Branchburg, New Jersey.
Cited most
Across all Amneal Pharmaceuticals observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.84(d)(2)Testing and approval or rejection of components, drug product containers, and closures1
The complete Amneal Pharmaceuticals 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
Branchburg, New Jersey
Two Form 483s · 2019 to 2022 · 6 observations
Latest: Form 483, Nov 18, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-11-18 | 483 Form 483 | Branchburg, New Jersey | 3 | $99 |
| 2019-02-21 | 483 Form 483 | Branchburg, New Jersey | 3 | $99 |
Investigators on these documents
FEI number 3004488497 · most recent document Nov 18, 2022
About Amneal Pharmaceuticals, LLC
How many FDA Form 483s has Amneal Pharmaceuticals, LLC received?
FDA Intel has 2 Form 483s on file for Amneal Pharmaceuticals, LLC; the most recent is dated Nov 18, 2022.
When was Amneal Pharmaceuticals, LLC last inspected by FDA?
The most recent FDA inspection document on file for Amneal Pharmaceuticals, LLC is a Form 483 dated Nov 18, 2022, for the site in Branchburg, New Jersey.
What did FDA cite at Amneal Pharmaceuticals, LLC?
The regulations cited most in the observations on file for Amneal Pharmaceuticals, LLC are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.42 (Design and construction features), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.