FDA 483 - Cardinal Health 414 LLC - January 09, 2024

An FDA inspection of Cardinal Health 414 LLC in Beltsville, MD, from January 4-9, 2024, revealed that the firm failed to follow its written quality assurance procedures. Specifically, the company did not thoroughly review unexplained discrepancies or implement adequate corrective and preventive actions for nonconformances related to cleaning, environmental monitoring, and microbial growth.