Jiangsu Xinbei Electrical Appliance Co., LTD.November 9, 2023

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

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Record Details

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.

Company: Jiangsu Xinbei Electrical Appliance Co., LTD.
Inspection Date: November 9, 2023
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Catherine J. Laufmann (Consumer Safety Officer)

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ID · 7008427e-4570-425c-a491-52f811910ce6