FDA 483 - OSRX Inc. - September 23, 2021

OSRX, Inc. dba Pinnacle Compounding in Missoula, MT, a producer of sterile drug products, was inspected by the FDA. The inspection revealed a significant concern regarding the firm's laminar airflow studies (smoke studies). These studies were found not to be representative of current aseptic compounding practices, failing to simulate critical operations and interventions used during sterile drug production.