FDA 483 - OSRX Inc. - November 03, 2025

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from November 3 to November 14, 2025, OSRX Inc., an outsourcing facility in Missoula, MT, received a Form 483 detailing significant observations. The inspection revealed critical deficiencies across production, quality, and laboratory operations, indicating a failure to adhere to established good manufacturing practices for sterile drug products.In production, the FDA noted that procedures designed to prevent microbiological contamination were not consistently followed. Issues included inadequate active viable and non-viable air sampling, media fills and aseptic process simulations that did not accurately represent routine production, and insufficient smoke studies. Furthermore, disinfectant efficacy studies for cleanroom disinfectants were not performed.Quality system observations highlighted an inadequate complaint handling process, where patient reports of product issues were not consistently investigated or documented. Additionally, Out-of-Specification (OOS) investigations often failed to identify root causes for product deviations, leading to product release without proper resolution.Laboratory findings included a lack of established procedures for identifying organisms during sterility test failures. Control over computer systems was also found to be deficient, specifically regarding the absence of audit trail reviews for analytical instruments like High-Performance Liquid Chromatography (HPLC) prior to drug product release.OSRX Inc. is required to implement comprehensive corrective and preventive actions to address these observations, ensuring the integrity and sterility of its drug products and compliance with regulatory expectations for outsourcing facilities.