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# CGMP Violations at Par Health USA/Endo USA
- URL: https://www.fdaweb.com/cgmp-violations-at-par-health-usa-endo-usa/
- Published: 2026-04-21T12:00:00.000Z
- Updated: 2026-09-14T13:37:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161014

A 10/6-10/20/2025 FDA inspection at the Par Health USA/Endo USA drug manufacturing facility in Rochester, MI, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/15 Warning Letter says the specific violations were:

- failure to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mixups in aseptic processing areas;
- failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and including validation of all aseptic and sterilization processes; and
- failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.

FDA says it encourages the use of suitable automatic visual inspection for particulates to augment the visual inspection program. It notes that significant inspection findings demonstrate that the firm does not operate an effective quality system in accordance with CGMP. The agency says the firm’s executive management should immediately and comprehensively assess the company’s global manufacturing operations to ensure that its systems, processes, and products conform to FDA requirements.

Par/Endo was told to promptly correct violations and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, along with a schedule for completing the corrections.