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Par Health USA, LLC & Endo USA, Inc. Warning Letter Details

Warning Letter

Par Health USA, LLC & Endo USA, Inc.

Recipient Title VP Manufacturing Operations, Par Health USA, LLC & Endo USA, Inc., 870 Parkdale Road Rochester , MI 48307-1740 United States

Issue DateApril 15, 2026

FEI Number1818977

Violations3

CountryUnited States

Issuing Office

Center for Drug Evaluation and Research (CDER)

Product Type

Drugs

Status

Open

Subject

CGMP/Finished Pharmaceuticals/Adulterated

Par Health USA, LLC & Endo USA, Inc. FDA Warning Letter, April 15, 2026