FDA 483 - UCLA Biomedical Cyclotron - July 31, 2025

An FDA inspection of UCLA Biomedical Cyclotron in Los Angeles, a PET drug manufacturer, revealed significant deficiencies. The firm failed to approve processes before implementation, specifically regarding media fill simulations that did not reflect actual production. Additionally, the quality of microbiological media used in testing was not adequately controlled, and required testing on finished PET drug products was not performed before release.