FDA 483 - Southern California Compounding Pharmacy, LLC - August 01, 2019

An FDA inspection of Southern California Compounding Pharmacy, LLC, conducted from July 8 to August 1, 2019, identified significant deficiencies in their manufacturing and quality control processes. The firm, a producer of sterile and non-sterile drug products, received a Form FDA 483 outlining multiple observations related to inadequate Good Manufacturing Practices. Key issues included deficient personnel and environmental monitoring within ISO 5 sterile environments, specifically regarding the lack of growth promotion for media and positive controls for sampling. Gowning and aseptic practices were found to be inadequate, with operators observed having exposed skin during sterile operations and cleaning. Furthermore, the firm's cleaning and disinfecting procedures for aseptic processing areas were substandard, involving the use of non-sterile wipes and un-sanitized items. The inspection also highlighted an inadequate smoke study for verifying unidirectional airflow in the ISO 5 Laminar Airflow Workstation, which is critical for sterile product manufacturing. Lastly, laboratory controls for finished non-sterile drug products were found to be deficient, lacking essential testing for microorganisms. Southern California Compounding Pharmacy, LLC is now required to address these observations by implementing comprehensive corrective and preventive actions to ensure compliance with regulatory standards for drug product safety and quality.