FDA 483 - Hunan Vathin Medical Instrument Co., Ltd. - March 01, 2024

Hunan Vathin Medical Instrument Co., Ltd. in Xiangtan, China, was inspected by the FDA, revealing significant deficiencies in its quality system. The inspection found that the firm had not established adequate procedures for design control, complaint handling, and corrective and preventive actions, indicating a lack of fundamental quality management processes for medical device manufacturing.