China NMPA Inspection - Zhejiang Kehui Medical Instrument Co., Ltd. - June 23, 2017

An unannounced inspection by the State Food and Drug Administration (NMPA) between May 22-24, 2017, revealed serious deficiencies at Zhejiang Sujia Medical Device Co., Ltd., a manufacturer of disposable electronic controlled analgesia pumps. Operating under the "Measures for Unannounced Inspections of Drugs and Medical Devices" and the "Good Manufacturing Practice for Medical Devices," the inspection identified four critical violations in the company's production quality management system. These included significant discrepancies in micro-motor specifications between design and production documentation without proper risk assessment, and inadequate raw material testing for polyvinyl chloride film, which failed to meet national mandatory standards. Furthermore, finished product testing was found insufficient, with the leakage current measuring instrument lacking the ability to detect required DC components, and dielectric strength testing being omitted from inspection procedures and reports. Consequently, Zhejiang Sujia Medical Device Co., Ltd. has been ordered to immediately cease production for rectification, address all identified legal violations, and pass a follow-up inspection by the Zhejiang Provincial Food and Drug Administration before resuming operations. The provincial authority is also mandated to publicly disclose these actions and strengthen ongoing supervision to ensure full compliance with medical device regulations, thereby safeguarding product safety and effectiveness.