China NMPA Inspection - Phytoconcile (Shanghai) Medical Devices Co., Ltd. - January 09, 2018

Phytoconcile (Shanghai) Medical Devices Co., Ltd. underwent an unannounced compliance inspection by the Shanghai Municipal Food and Drug Administration on November 20-21, 2017. The inspection, based on the Good Manufacturing Practice for Medical Devices, revealed four general defects. Key issues included inadequate training records, specifically lacking training plans and assessments. The company also failed to segregate medical and non-medical devices in its warehouse, storing items like 'chargers' alongside medical products. Furthermore, daily temperature and humidity records were incomplete, with no data recorded for weekends. Finally, the company lacked established early warning measures for inventory products approaching their expiration dates. In response to these findings, Phytoconcile is mandated to rectify all identified issues within a specified timeframe. The Shanghai Municipal Food and Drug Administration will conduct follow-up inspections and report the rectification status to the Medical Device Supervision Department of the State Administration for Market Regulation, adhering to the "Regulations on the Supervision and Administration of Medical Devices."