FDA 483 - Klarity Medical Products LLC - February 25, 2020

Klarity Medical Products LLC in Newark, OH, was inspected and cited for multiple deficiencies in its quality system. The inspection revealed significant issues across corrective and preventive actions, design change control, supplier agreements, rework procedures, acceptance activities, complaint handling, and process controls for manufacturing medical devices like Vacuum Bags and BiteLok devices. These issues indicate a systemic failure to establish and follow adequate procedures for ensuring product quality and regulatory compliance.