China NMPA Inspection - Shanghai Weining Plastic Surgery Products Co., Ltd. - July 18, 2018

Shanghai Weining Plastic Surgery Products Co., Ltd. underwent an unannounced causal inspection by the FDA NMPA on June 28-29, 2018, regarding its Silicone Gel Breast Implants. The inspection, based on the "Good Manufacturing Practice for Medical Devices" and its "Appendix for Implantable Medical Devices," uncovered significant deficiencies in the company's production quality management system. Four serious defects were identified, including an unreasonable cleanroom layout requiring improper access, inconsistencies in raw material records and purchasing, critical omissions in finished product inspection procedures (missing checks for product shell, residual small molecules, and edge angles), and the absence of a management representative's signature on product release review forms. Sixteen general defects were also found, encompassing deficiencies in equipment validation and status labeling, inadequate control of cleanroom environment and infrastructure, insufficient documentation and record-keeping, uncalibrated instruments, laboratory equipment issues, a lack of personnel protection procedures for hazardous materials, improper disinfectant management, undefined batch number generation for export products, and missing water quality monitoring records. As a result, the Shanghai Food and Drug Administration ordered Shanghai Weining Plastic Surgery Products Co., Ltd. to immediately cease production and rectify all identified issues. The company is required to assess product safety risks, recall any potentially hazardous products, and face legal action for non-compliance with medical device regulations.