FDA 483 - Dana Medical Co., Ltd - April 06, 2023

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.