FDA 483 - Carefusion 2200 Inc - October 19, 2022

Carefusion 2200 Inc, a medical device manufacturer in Vernon Hills, IL, was inspected by the FDA. The inspection revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures and the reporting of recall actions. Specifically, the firm failed to adequately address known product integrity issues for sterilization containers and provided inaccurate information in a recall report to the FDA.