Contego Medical, Inc – FDA 483, May 22, 2026

Contego Medical, Inc. in Raleigh, NC, received a Form 483 with eight observations highlighting significant deficiencies in its quality system. The firm failed to adequately implement corrective and preventive actions, maintain complete design control documentation, ensure proper complaint handling and medical device reporting, and effectively manage outsourced processes and risk. These issues indicate a systemic breakdown in quality management, potentially impacting the safety and effectiveness of their Neuroguard IEP System and Paladin devices.