Amneal Oncology Private Limited
FDA inspection history in Mahaboobnagar, India, 2018 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Mahaboobnagar, India.
- 2023One Form 483, at Mahaboobnagar, India.
- 2023The longest 483 on file: 9 observations over 10 pages at Mahaboobnagar, India.
Cited most
Across all Amneal Oncology Private Limited observations on file
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.192Production record review2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.160General requirements1
- 21 CFR 211.165Testing and release for distribution1
The complete Amneal Oncology 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
Mahaboobnagar, India
Two Form 483s · 2018 to 2023 · 13 observations
Latest: Form 483, Nov 17, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-11-17 | 483 Form 483 | Mahaboobnagar, India | 9 | $99 |
| 2018-03-15 | 483 Form 483 | Mahaboobnagar, India | 4 | $99 |
Investigators on these documents
Anastasia M. Shields (1)Carrie A. Hughes (1)Eileen A. Liu (1)Rajiv R. Srivastava (1)
FEI number 3005903939 · most recent document Nov 17, 2023
About Amneal Oncology Private Limited
How many FDA Form 483s has Amneal Oncology Private Limited received?
FDA Intel has 2 Form 483s on file for Amneal Oncology Private Limited; the most recent is dated Nov 17, 2023.
When was Amneal Oncology Private Limited last inspected by FDA?
The most recent FDA inspection document on file for Amneal Oncology Private Limited is a Form 483 dated Nov 17, 2023, for the site in Mahaboobnagar, India.
What did FDA cite at Amneal Oncology Private Limited?
The regulations cited most in the observations on file for Amneal Oncology Private Limited are 21 CFR 211.100(a) (Written procedures; deviations), 2 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 1 time.