FDA 483 - Advanced Bionics Corp.

An FDA inspection of Advanced Bionics Corp. in Sylmar, CA, revealed significant deficiencies in medical device reporting (MDR) and quality system management. The firm failed to report evaluation results for explanted cochlear implants, did not submit initial MDR events, and submitted erroneous MDR forms. Additionally, the firm failed to submit PMA supplements for various manufacturing and design changes, and management did not ensure adequate resources for prompt failure analysis and complete MDR reporting.