FDA 483 - Cardinal Health 414 LLC - August 28, 2025

Cardinal Health 414 LLC, a PET drug manufacturer in Van Nuys, CA, was cited for failing to approve processes and procedures before implementation. The inspection revealed deficiencies in media fill simulations, which did not adequately qualify production operators or represent actual manufacturing conditions. Additionally, the visual inspection test kit used for operator qualification was deemed inadequate, indicating a lack of robust quality control over critical manufacturing processes.