Endo USA, Inc.
Warning letter issued April 15, 2026 · Rochester, Michigan
- Inspection
- Oct 6 – Oct 20, 2025
- Pages
- 9
- FEI number
- 1818977
In short: On April 15, 2026, FDA sent a warning letter to Endo USA, Inc. in Rochester, Michigan (FEI 1818977).
Inside this warning letter
The full warning letter
Every page of the warning letter, exactly as written.
Get the full warning letterThis inspection in context
Questions about this warning letter
When was Endo USA, Inc. inspected by FDA?
The inspection ran Oct 6 – Oct 20, 2025, and the Warning letter is dated April 15, 2026.
How do I get the full Warning letter for Endo USA, Inc.?
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.