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

Cardinal Health 414 LLC, a PET Manufacturer in Tampa, FL, was cited for significant quality system deficiencies during an FDA inspection. Observations included failures to establish and follow written quality assurance procedures, inadequate corrective actions for nonconforming products, incomplete investigations into sterility failures, and deficient complaint records. These issues indicate a lack of robust control over manufacturing processes and quality management.