Amneal Oncology Private Limited
Form 483 issued March 15, 2018 · Mahaboobnagar, India
- Inspection
- Mar 8 – Mar 15, 2018
- Investigators
- Anastasia M. Shields· Carrie A. Hughes
- Observations
- 4
- Pages
- 6
- FEI number
- 3005903939
In short: On March 15, 2018, FDA issued a Form 483 with 4 observations to Amneal Oncology Private Limited in Mahaboobnagar, TG (FEI 3005903939) after an inspection that ran Mar 8 – Mar 15, 2018. The investigators were Anastasia M. Shields and Carrie A. Hughes. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
The quality control unit lacks authority to review production records to assure that no errors have…
- 03
Deviations from written production and process control procedures are…
- 04
Written records of investigations into unexplained discrepancies do not always include…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
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 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amneal Oncology Private Limited?
FDA listed 4 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Amneal Oncology Private Limited?
Anastasia M. Shields and Carrie A. Hughes are named on this Form 483, for the inspection of Mar 8 – Mar 15, 2018. Each investigator has a profile showing what they cite most.
When was Amneal Oncology Private Limited inspected by FDA?
The inspection ran Mar 8 – Mar 15, 2018, and the Form 483 is dated March 15, 2018.
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.