FDA 483 - OSRX Inc. - November 14, 2025

OSRX Inc., an outsourcing facility in Missoula, MT, was inspected and cited for significant deficiencies in its manufacturing and quality control systems. The inspection revealed failures in preventing microbiological contamination during sterile drug production, including inadequate aseptic process simulations and smoke studies, some of which were repeat observations. Additionally, the firm's complaint handling and out-of-specification investigations were found to be insufficient, and critical laboratory test methods lacked established reproducibility and proper computer system controls.