FDA 483 - OSRX Inc. - October 25, 2024

From October 16-25, 2024, the FDA inspected OSRX Inc., an outsourcing facility in Missoula, MT, with FEI Number 3014549846. The inspection revealed six observations regarding the firm's compliance with regulations for sterile drug product manufacturing and quality control.

**Observation 1: Deficient Procedures for Preventing Microbiological Contamination** * **Aseptic Operator Qualification:** Personnel media fills were insufficient, with operators filling only a small fraction of units compared to maximum batch sizes, inadequately assessing aseptic technique. * **Media Fill Incubation:** Not all integral units from media fills were incubated, with units removed for testing or production loss reasons not being incubated or justified. * **Gowning Qualification:** No gowning qualification program existed for entering Cleanroom Suite 100, failing to ensure sterile gowning without contamination. * **Smoke Study:** A smoke study performed on March 29, 2024, was not conducted under dynamic conditions, failing to simulate aseptic processing behavior with multiple employees.

**Observation 2: Failure to Thoroughly Review Discrepancies** * **Environmental Monitoring Exceedances:** Quality events with environmental monitoring recoveries exceeding specification limits were not thoroughly investigated, lacking adequate corrective actions, scientific justification, and impact assessments before product release. Examples include Staphylococcus epidermidis and Staphylococcus lentus recoveries. * **