FDA 483 - Advanced Medical Design Co., Ltd. - January 19, 2023

Advanced Medical Design Co., Ltd. in New Taipei City, Taiwan, a medical device manufacturer, was inspected and cited for significant quality system deficiencies. Observations included inadequate procedures for evaluating purchased products and services, failure to register a contract manufacturer with the FDA, and systemic issues with complaint handling and investigation. Additionally, the firm failed to submit a Medical Device Report (MDR) within the required 30-day timeframe for a serious injury event.