FDA 483 - Cardinal Health 414 LLC - February 06, 2026

Cardinal Health 414 LLC in Tampa, FL, a PET drug manufacturer, was cited for significant quality system deficiencies. Observations included failures to establish and follow written quality assurance procedures, inadequate corrective actions for nonconforming products, and incomplete investigations into sterility out-of-specification results. Additionally, complaint records lacked essential information regarding the nature and follow-up of adverse events.