Amneal Pharmaceuticals Private Limited
FDA inspection history in Ahmedabad, India, 2018 to 2024
- 3
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2022: 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 Ahmedabad, India.
- 2022–24Two Form 483s, at Ahmedabad, India.
- 2022The longest 483 on file: 4 observations over 9 pages at Ahmedabad, India.
Cited most
Across all Amneal Pharmaceuticals Private Limited observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.28Personnel responsibilities1
The complete Amneal Pharmaceuticals Private Limited file.
All 3 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
Ahmedabad, India
Three Form 483s · 2018 to 2024 · 9 observations
Latest: Form 483, Jun 19, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-06-19 | 483 Form 483 | Ahmedabad, India | 4 | $99 |
| 2022-12-23 | 483 Form 483 | Ahmedabad, India | 4 | $99 |
| 2018-04-24 | 483 Form 483 | Ahmedabad, India | 1 | $99 |
Investigators on these documents
Bijoy Panicker (1)Jigar R. Patel (1)Marie B. Buen-Bigornia (1)Niketa Patel (1)Thomas J. Arista (1)
FEI number 3010254278 · most recent document Jun 19, 2024
About Amneal Pharmaceuticals Private Limited
How many FDA Form 483s has Amneal Pharmaceuticals Private Limited received?
FDA Intel has 3 Form 483s on file for Amneal Pharmaceuticals Private Limited; the most recent is dated Jun 19, 2024.
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 Jun 19, 2024, 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 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.