FDA 483 - Jiangsu Xinbei Electrical Appliance Co., LTD. - November 09, 2023

Jiangsu Xinbei Electrical Appliance Co., LTD. in Wuxi, China, received a Form FDA 483 with seven observations during an inspection. The firm demonstrated significant deficiencies in its quality system, including inadequate procedures for complaint handling, medical device reporting, corrective and preventive actions, and control of nonconforming products. Additionally, issues were noted with documentation for design validation, design reviews, and equipment calibration.