China NMPA Inspection - Suzhou Frankman Medical Devices Co., Ltd. - June 23, 2017

An unannounced inspection by the State Food and Drug Administration (SFDA) in May 2017, targeting medical device manufacturers, identified significant compliance issues at Suzhou Frankman Medical Device Co., Ltd., and Changzhou Weike Medical Device Co., Ltd. For Suzhou Frankman, inspected from May 24-26, 2017, under the "Good Manufacturing Practice for Medical Devices" and its "Appendix: Sterile Medical Devices," 16 general defects were found. These included critical deficiencies in their quality management system, such as a lack of management representative identification, unrecorded dehumidifier operations, and expired calibration of testing equipment. Problems extended to supplier management, with expired supplier certificates and outdated cleanroom reports, and environmental control issues in cleanroom areas, including high humidity readings and unverified compressed air used for direct product contact. The SFDA, in a June 20, 2017 notification, instructed the Jiangsu Provincial Food and Drug Administration to ensure both companies rectify these issues within a set timeframe. This includes conducting follow-up inspections, assessing product safety risks, and initiating recalls if necessary, in accordance with the "Regulations on the Recall Management of Medical Devices." Furthermore, the provincial administration must enhance daily supervision, increase inspection frequency, analyze root causes, and strictly enforce GMP requirements to guarantee the safety and effectiveness of medical devices.