Amneal Pharmaceuticals Private Limited
FDA inspection history in Ahmedabad, India, 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 Ahmedabad, India.
Cited most
Across all Amneal Pharmaceuticals Private Limited observations on file
- 21 CFR 211.160General requirements1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Amneal Pharmaceuticals Private Limited file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Ahmedabad, India
One Form 483 · 2023 · 2 observations
Latest: Form 483, May 2, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-05-02 | 483 Form 483 | Ahmedabad, India | 2 | $99 |
Investigators on these documents
FEI number 3017573557 · most recent document May 2, 2023
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 May 2, 2023.
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 May 2, 2023, for the site in Ahmedabad, 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 211.160 (General requirements), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.