FDA 483 - UCLA Biomedical Cyclotron - July 31, 2020

UCLA Biomedical Cyclotron, a PET drug manufacturer in Los Angeles, CA, was cited for significant deficiencies across its quality and laboratory control systems during an FDA inspection. Observations included failures in equipment qualification, analytical method validation, record-keeping, and quality assurance procedures, with one observation being a repeat from a previous inspection. These issues indicate a lack of robust controls necessary to ensure the quality and purity of PET drug products.