483
Dana Medical Co., LtdDana Medical Co., Ltd – FDA 483, Apr 6, 2023
Record Details
Dana Medical Co., Ltd, a medical device manufacturer in Jangseong-gun, Korea, was inspected by the FDA from April 3-6, 2023. The inspection revealed significant deficiencies in their quality system, specifically concerning complaint handling, corrective and preventive actions, nonconforming product control, and design review procedures. These issues indicate a lack of adequate controls for ensuring product quality and regulatory compliance.
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ID · 823892e8-a26b-48a4-af4d-91fc5ad8cf39
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