Amneal Pharmaceuticals Private Limited
FDA inspection history across 2 sites, 2025
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2025: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2025One warning letter and one Form 483, at Brookhaven, New York and Mehsana, India.
Cited most
Across all Amneal Pharmaceuticals Private Limited observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.160General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Amneal Pharmaceuticals Private Limited 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
Brookhaven, New York
One warning letter · 2025
Latest: Warning letter, Aug 27, 2025 →Mehsana, India
One Form 483 · 2025 · 4 observations
Latest: Form 483, Mar 19, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-08-27 | Warning letter Warning letter | Brookhaven, New York | — | $99 |
| 2025-03-19 | 483 Form 483 | Mehsana, India | 4 | $99 |
Investigators on these documents
FEI number 3018907202 · most recent document Aug 27, 2025
About Amneal Pharmaceuticals Private Limited
How many FDA Form 483s has Amneal Pharmaceuticals Private Limited received?
FDA Intel has 1 Form 483 on file for Amneal Pharmaceuticals Private Limited; the most recent is dated Mar 19, 2025.
When was Amneal Pharmaceuticals Private Limited last inspected by FDA?
The most recent FDA inspection document on file for Amneal Pharmaceuticals Private Limited is a Form 483 dated Mar 19, 2025, for the site in Mehsana, India.
What did FDA cite at Amneal Pharmaceuticals Private Limited?
The regulations cited most in the observations on file for Amneal Pharmaceuticals Private Limited are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.192 (Production record review), 1 time.
Has Amneal Pharmaceuticals Private Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Amneal Pharmaceuticals Private Limited; the most recent is dated Aug 27, 2025.