FDA 483 - Cardinal Health 414 LLC - March 18, 2021

Cardinal Health 414 LLC in Las Vegas, NV, was inspected from March 16-18, 2021, and received a Form 483 citing a significant deficiency in production and process controls. The firm lacked adequate controls to ensure consistent production of PET drugs, specifically regarding cleaning and disinfection methods and contact times within ISO 5 hot cells and laminar air flow work stations. This indicates potential issues with the quality and purity of their PET drug products.