FDA 483 - Centurion Medical Products, LP - November 01, 2019

Centurion Medical Products Corporation in Williamston, MI, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to adequately establish design history files, implement effective corrective and preventive actions, ensure purchased products conform to requirements, and validate critical inspection processes. These issues led to the distribution of nonconforming medical devices, including occluded catheters and convenience kits with incomplete seals, some resulting in patient harm and a Class II recall.