FDA 483 - Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co, Ltd. - January 14, 2020

An FDA inspection of Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co, Ltd. in Chengdu, China, revealed significant deficiencies in its quality system for medical devices. The firm failed to adequately establish procedures for complaint handling, sterilization validation, and design controls for its sterile Intravenous Sets and syringes intended for the US market. These issues are serious, especially given the firm's export of devices to the US without proper 510(k) clearance.