FDA 483 - Medtronic (Changzhou) Medical Devices Technology Co Ltd - December 15, 2011

Changzhou Kanghui Medical Innovation Co., Ltd. in Changzhou, China, a medical device manufacturer, was cited for significant deficiencies in its quality system during an FDA inspection. The inspection revealed inadequate procedures for corrective and preventive actions, control of non-conforming products, and conducting quality audits. Additionally, device history records did not consistently demonstrate manufacturing in accordance with master records, showing discrepancies in unit counts and missing product labels.