FDA 483 - West Coast Nuclear Pharmacy - March 23, 2018

During an inspection conducted from March 19-23, 2018, the FDA identified significant deficiencies at West Coast Nuclear Pharmacy, LLC, a nuclear pharmacy in Tampa, FL. The inspection highlighted critical issues in aseptic processing and environmental control essential for manufacturing sterile radiopharmaceuticals. Main violations included the presence of actionable microbial contamination, specifically Bacillus spp., in the ISO 5 aseptic area without adequate sporicidal treatment. Inspectors observed poor aseptic practices, such as personnel touching non-sterile surfaces with gloved hands before continuing sterile operations without proper sanitation, and rapid movements disrupting controlled airflow. Additional concerns involved the lack of comprehensive media fills simulating worst-case production, a facility design allowing lower-quality air into cleanrooms, and the use of non-sterile cleaning agents and wipes in critical areas. The company also failed to perform post-sterilizing filter testing and lacked an appropriate whole-room disinfection schedule based on environmental monitoring. These observations indicate non-compliance with fundamental quality system requirements for sterile drug manufacturing. West Coast Nuclear Pharmacy, LLC must promptly address these deficiencies to ensure product sterility, prevent contamination, and uphold patient safety in accordance with regulatory standards.