Amneal Pharmaceuticals Private Limited
Form 483 issued June 19, 2024 · Ahmedabad, India
- Inspection
- Jun 10 – Jun 19, 2024
- Investigators
- Bijoy Panicker· Jigar R. Patel
- Observations
- 4
- Pages
- 4
- FEI number
- 3010254278
In short: On June 19, 2024, FDA issued a Form 483 with 4 observations to Amneal Pharmaceuticals Private Limited in Ahmedabad, Gujarat (FEI 3010254278) after an inspection that ran Jun 10 – Jun 19, 2024. The investigators were Bijoy Panicker and Jigar R. Patel. Most observations concern production and facilities & equipment.
At a glance
3 of 4 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 04
Routine calibration of electronic equipment is not performed according to a written program designed…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
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 211.100
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 facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Amneal Pharmaceuticals Private Limited?
Bijoy Panicker and Jigar R. Patel are named on this Form 483, for the inspection of Jun 10 – Jun 19, 2024. Each investigator has a profile showing what they cite most.
When was Amneal Pharmaceuticals Private Limited inspected by FDA?
The inspection ran Jun 10 – Jun 19, 2024, and the Form 483 is dated June 19, 2024.
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.