Amneal Pharmaceuticals Private Limited

Warning letter issued August 27, 2025 · Brookhaven, New York

Inspection: Mar 10 – Mar 19, 2025
Pages: 6
FEI number: 3018907202

In short: On August 27, 2025, FDA sent a warning letter to Amneal Pharmaceuticals Private Limited in Brookhaven, New York (FEI 3018907202).

Inside this warning letter

The full warning letter

Every page of the warning letter, exactly as written.

Get the full warning letter

This inspection in context

The firm

Amneal Pharmaceuticals Private Limited history

All 2 documents on file for this site, in date order, with what was cited at each inspection.

Complete the picture

483
Form 483 from this inspectionMar 19, 2025$99

Amneal Pharmaceuticals Private Limited site file

All 2 documents for this site in one go: $198.

See the site history

Questions about this warning letter

When was Amneal Pharmaceuticals Private Limited inspected by FDA?

The inspection ran Mar 10 – Mar 19, 2025, and the Warning letter is dated August 27, 2025.

How do I get the full Warning letter 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.