The letter outlines concerns regarding the marketing of convenience kits containing piston syringes without proper FDA approval. These devices are deemed adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act.
Furthermore, the FDA highlighted quality system regulation violations, particularly in the establishment of procedures to ensure product conformity and manufacturing controls. Cardinal Health’s failure to adequately address these violations may result in regulatory action, including seizure and injunction.
The letter requests prompt action to address the noted violations and urges Cardinal Health to provide a comprehensive response detailing corrective actions taken and plans for prevention. Failure to comply may impact the company’s ability to receive federal contracts and approval for certain medical devices.
Overall, the FDA emphasizes the importance of compliance with regulations to ensure the safety and effectiveness of medical devices distributed by Cardinal Health