FDA 483 - Cardinal Health 414, LLC - July 31, 2025

Cardinal Health 414, LLC, a PET Drug Manufacturer & Nuclear Pharmacy in Fort Lauderdale, FL, was cited for significant deficiencies in aseptic processing, environmental control, and quality assurance procedures. Observations included blocked "first air" in ISO areas, inadequate disinfection and gowning practices, and repeated failures to follow and properly document quality assurance procedures, particularly concerning Bacterial Endotoxin Test (BET) investigations and corrective actions. The findings indicate a need for improved adherence to established protocols and robust investigation processes to prevent recurrence of quality problems.