China NMPA Inspection - Gansu Weikang Medical Equipment Co., Ltd. - January 09, 2018

Gansu Weikang Medical Equipment Co., Ltd. underwent an unannounced compliance inspection on November 21, 2017, based on the "Good Manufacturing Practice for Medical Devices" standard. The inspection revealed four general deficiencies concerning the company's quality management system. Key issues included an overly general training plan lacking specific content and assessment records, a failure to timely establish health records for some new personnel, and inadequate warehouse organization with no distinct shipping or return areas. Furthermore, the company's warehouse temperature and humidity monitoring records were only maintained once daily, contrary to the required twice-daily frequency. Consequently, the Gansu Provincial Food and Drug Administration is directed to order the company to implement corrective actions within a specified period. A subsequent follow-up inspection will verify these rectifications, and the outcomes will be reported to the Medical Device Supervision Department of the State Administration for Market Regulation, underscoring the company's obligation to maintain a robust and effective quality management system.