Amneal Pharmaceuticals Private Limited
Form 483 issued December 23, 2022 · Ahmedabad, India
- Inspection
- Dec 13 – Dec 23, 2022
- Investigator
- Thomas J. Arista
- Observations
- 4
- Pages
- 9
- FEI number
- 3010254278
In short: On December 23, 2022, FDA issued a Form 483 with 4 observations to Amneal Pharmaceuticals Private Limited in Ahmedabad, Gujarat (FEI 3010254278) after an inspection that ran Dec 13 – Dec 23, 2022. The investigator was Thomas J. Arista. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 4 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The Personnel behavior and practices in aseptic process area, document number AP-SMC-020, establish the responsibility of…
- 02
To perform the requisite aseptic set up operations of the aseptic fill line a Parenteral, the…
- 03
Production operators wear protective eyewear (i.e., goggles) during the aseptic processing of…
- 04
The Summary Report for Disinfectant Qualification, document number AP-QCM-MIS-43-00, dated Aug 23, 2022; consists of a…
This inspection in context
Thomas J. Arista
21 documents · 2001–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmAmneal Pharmaceuticals Private Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amneal Pharmaceuticals Private Limited?
FDA listed 4 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Amneal Pharmaceuticals Private Limited?
Thomas J. Arista is named on this Form 483, for the inspection of Dec 13 – Dec 23, 2022. Each investigator has a profile showing what they cite most.
When was Amneal Pharmaceuticals Private Limited inspected by FDA?
The inspection ran Dec 13 – Dec 23, 2022, and the Form 483 is dated December 23, 2022.
How do I get the full Form 483 for Amneal Pharmaceuticals 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.