FDA 483 - Medtronic (Changzhou) Medical Devices Technology Co Ltd - August 20, 2015

Changzhou Kanghui Medical Innovation Co., Ltd. in Changzhou, China, was inspected by the FDA from August 17-20, 2015. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding corrective and preventive action procedures and device history record management. These issues indicate a lack of adequate controls over product quality and record-keeping.