FDA 483 - Cardinal Health 200, LLC - December 20, 2023

An FDA inspection of Cardinal Health 200, LLC in Waukegan, IL, revealed significant deficiencies in their quality system for medical devices. Observations included inadequate corrective and preventive action procedures, insufficient controls over purchased products and suppliers, and sampling plans not based on valid statistical rationale. These issues primarily concerned Monojet Syringes and could lead to device failures and patient harm.