483
Jiangsu Xinbei Electrical Appliance Co., LTD.Jiangsu Xinbei Electrical Appliance Co., LTD. – FDA 483, Nov 9, 2023
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.
- Inspection date
- November 9, 2023
- Product type
- device
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ID · 7008427e-4570-425c-a491-52f811910ce6
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