FDA 483 - NEURELEC - June 02, 2022

An FDA inspection of Oticon Medical, a manufacturer of Cochlear Implant devices, revealed significant deficiencies in its quality system. The firm failed to adequately establish procedures for complaint handling, including timely processing, documentation, and Medical Device Report (MDR) reportability evaluations. Additionally, corrective and preventive action activities, particularly investigations into device failures leading to recalls, were not properly documented.