FDA 483 - Cardinal Health 414 LLC - January 23, 2026

Cardinal Health 414 LLC in Phoenix, AZ, a PET drug manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included inadequate procedures for equipment cleaning, leading to Aspergillus contamination in manufacturing areas, and facility conditions that failed to prevent product contamination. These issues pose a risk to the quality and sterility of PET drugs intended for patient infusion.