483
Beijing Kingst Commercial & Trade Co., Ltd.Beijing Kingst Commercial & Trade Co., Ltd. – FDA 483, Apr 25, 2024
Record Details
An FDA inspection of Beijing Kingst Commercial & Trade Co. Ltd., a medical device manufacturer in Beijing, China, revealed a significant deficiency in their quality system. The firm failed to adequately establish process control procedures for soldering operations during the assembly of Class II medical devices, specifically lacking clear descriptions and parameters to ensure product specifications are met.
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ID · a8f32bc9-eb4b-4aae-867e-d01600720305
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