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FDA Warns Par Health Endo USA for Sterile Injectable CGMP Violations

FDA issued Warning Letter 320-26-68 to Par Health USA, LLC and Endo USA, Inc. following an October 2025 inspection of their sterile injectable drug manufacturing facility in Rochester, MI. Investigators documented significant CGMP violations including inadequate aseptic processing line design, deficient environmental monitoring, and improper unidirectional airflow protection. FDA determined the firm's November 2025 response was inadequate and that its drug products are adulterated under Section 501(a)(2)(B) of the FD&C Act.