Amneal Pharmaceuticals of New York, LLC
FDA inspection history in Brookhaven, New York, 2023
- 1
- Form 483
Every document, by year
- Form 483
2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One Form 483, at Brookhaven, New York.
Cited most
Across all Amneal Pharmaceuticals of New York observations on file
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.67Equipment cleaning and maintenance1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
The complete Amneal Pharmaceuticals of New York file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Brookhaven, New York
One Form 483 · 2023 · 5 observations
Latest: Form 483, Jun 7, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-06-07 | 483 Form 483 | Brookhaven, New York | 5 | $99 |
Investigators on these documents
FEI number 3005263655 · most recent document Jun 7, 2023
About Amneal Pharmaceuticals of New York, LLC
How many FDA Form 483s has Amneal Pharmaceuticals of New York, LLC received?
FDA Intel has 1 Form 483 on file for Amneal Pharmaceuticals of New York, LLC; the most recent is dated Jun 7, 2023.
When was Amneal Pharmaceuticals of New York, LLC last inspected by FDA?
The most recent FDA inspection document on file for Amneal Pharmaceuticals of New York, LLC is a Form 483 dated Jun 7, 2023, for the site in Brookhaven, New York.
What did FDA cite at Amneal Pharmaceuticals of New York, LLC?
The regulations cited most in the observations on file for Amneal Pharmaceuticals of New York, LLC are 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time; 21 CFR 211.67 (Equipment cleaning and maintenance), 1 time.