FDA 483 - Advanced Bionics, LLC - September 15, 2004

An FDA inspection of Advanced Bionics Corporation revealed significant quality system deficiencies, primarily concerning moisture entrapment in hermetically sealed cochlear implants, leading to device failures. The firm failed to adequately report these issues to the FDA, conduct proper management reviews, establish effective design and process validations, and implement robust corrective and preventive actions. These systemic problems expose patients to risks of device failure and surgical intervention.