FDA 483 - Jiangyin SINBON Electronics Co., Ltd. - April 17, 2025

An FDA inspection of Jiangyin SINBON Electronics Co., Ltd. in Wuxi, China, a contract manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for design change, corrective and preventive actions, and control of nonconforming products. These issues indicate a lack of robust quality management practices.