FDA 483 - Argenta US Manufacturing LLC - December 15, 2023

An FDA inspection of TriRx Shawnee, LLC revealed significant deficiencies in procedures designed to prevent microbiological contamination of sterile drug products. The firm failed to adequately respond to operator action level excursions, lacked scientific rationale for environmental monitoring limits, and did not implement effective corrective and preventative actions for recurring mold contamination in aseptic areas. These findings indicate a serious risk to the sterility of drug products manufactured at the facility.