Issued to Par Health USA, LLC & Endo USA, Inc.. Serious post-market compliance violation.
Issued
April 15, 2026Product
CGMP/Finished Pharmaceuticals/Adulterated
Company
Par Health USA, LLC & Endo USA, Inc.
Review center
CDERStage
Final Decision
Assyro regulatory brief
FreeSource facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
FDA issued a warning letter to Par Health USA, LLC & Endo USA, Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Laboratory controls and testing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
Review the exact FDA warning letter, cited violations, requested corrections, and any later response or closeout before assessing current status.
Open the document workspaceFDA source document
FDA publishes this warning letter as a web document.
Open the exact FDA source to read the complete letter and verify its current response or closeout status.
Serious post-market compliance violation. Public notice requiring prompt remediation. FDA issued this letter on April 15, 2026.
The firm is expected to respond in writing, normally within 15 working days, describing corrective actions and timelines. FDA verifies remediation — often through reinspection — and issues a closeout letter when violations are corrected. Unresolved warning letters can escalate to import alerts, seizure, or injunction.