Amneal Oncology Private Limited
Form 483 issued November 17, 2023 · Mahaboobnagar, India
- Inspection
- Nov 10 – Nov 17, 2023
- Investigators
- Eileen A. Liu· Rajiv R. Srivastava
- Observations
- 9
- Pages
- 10
- FEI number
- 3005903939
In short: On November 17, 2023, FDA issued a Form 483 with 9 observations to Amneal Oncology Private Limited in Mahaboobnagar, TG (FEI 3005903939) after an inspection that ran Nov 10 – Nov 17, 2023. The investigators were Eileen A. Liu and Rajiv R. Srivastava. Most observations concern facilities & equipment and laboratory controls.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Procedure designed to prevent microbiological contamination of drug products purporting to be sterile are not established…
- 03
Field Alert Report was not submitted within three working days of receipt of information concerning bacteriological…
- 04
Your firm failed to test samples of each component for conformity with all appropriate written specifications…
This inspection in context
Eileen A. Liu
41 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmAmneal Oncology Private Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amneal Oncology Private Limited?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Amneal Oncology Private Limited?
Eileen A. Liu and Rajiv R. Srivastava are named on this Form 483, for the inspection of Nov 10 – Nov 17, 2023. Each investigator has a profile showing what they cite most.
When was Amneal Oncology Private Limited inspected by FDA?
The inspection ran Nov 10 – Nov 17, 2023, and the Form 483 is dated November 17, 2023.
How do I get the full Form 483 for Amneal Oncology Private Limited?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.