FDA 483 - ROi CPS LLC - October 28, 2022

ROI CPS LLC, a manufacturer of Class II surgical kits in Republic, MO, was cited for significant deficiencies in its quality system. The inspection revealed inadequate corrective and preventive action procedures, leading to repeat nonconformities, and a failure to adequately establish procedures for ensuring purchased products and services meet specified requirements, particularly concerning supplier qualification. These issues indicate a systemic breakdown in quality management.