Recipient Title VP Manufacturing Operations, Par Health USA, LLC & Endo USA, Inc., 870 Parkdale Road Rochester , MI 48307-1740 United StatesFEI 1818977Issued Apr 15, 2026Center for Drug Evaluation and Research (CDER)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 1818977.
Violations3
Issue DateApr 15, 2026
Product TypeDrugs
StatusOpen
Letter Details
Firm
Par Health USA, LLC & Endo USA, Inc.
Location
Recipient Title VP Manufacturing Operations, Par Health USA, LLC & Endo USA, Inc., 870 Parkdale Road Rochester , MI 48307-1740 United States
FEI Number
1818977
Country
United States
Issue Date
April 15, 2026
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
Talk to a Specialist