FDA 483 - Contec Medical Systems Co., Ltd. - June 12, 2025

An FDA inspection of Contec Medical Systems Co., Ltd. in Qinhuangdao, China, revealed significant deficiencies in its quality system. The firm failed to adequately establish procedures for corrective and preventive actions, design validation (including software), and complaint handling. Additionally, the inspection found issues with record accessibility and an organizational structure where personnel lacked product familiarity and struggled to locate quality documentation.