FDA 483 - Mission Pharmacal Company - September 22, 2022

Mission Pharmacal Company in Boerne, TX, a drug product manufacturer, received two observations during an FDA inspection. The facility was cited for inadequate pest control, with live insects and glue boards found in a drug product coating room. Additionally, the firm failed to maintain written records and conduct investigations for unexplained discrepancies, specifically regarding a pinhole leak in manufacturing equipment.