China NMPA Inspection - Princeton Medical Technology (Zhuhai) Co., Ltd. - July 07, 2017

An unannounced inspection conducted by the State Food and Drug Administration on June 6-7, 2017, identified significant non-compliance at Princeton Medical Technology (Zhuhai) Co., Ltd. The inspection, carried out under the "Regulations on Unannounced Inspections of Drugs and Medical Devices," revealed critical deficiencies in the company's quality management system, particularly concerning its "Dynamic Glucose Monitoring System" product, even as it reported a halt in production for its "Disposable Insulin Pump Infusion Components." Key issues included the company's reliance on affiliated companies for shared sterile testing facilities, equipment, and water purification resources, lacking independent provisions for these crucial aspects. Specifically, the company did not possess its own testing facilities, and purchased purified water, while its internal process water management regulations lacked clarity. Furthermore, the rinsing room was found unsuitable for cleaning components requiring water for injection, a critical requirement for products interacting with substances like insulin. These findings indicate a failure to adhere to the *Good Manufacturing Practice for Medical Devices* and its *Appendix for Sterile Medical Devices*. Consequently, the Guangdong Provincial Food and Drug Administration is mandated to conduct immediate follow-up inspections of the company's operational products and affiliates. Rectification is required for any non-compliance identified. Production of the previously discontinued product may only resume after the company submits a compliance report and receives verification from the provincial authorities. The provincial bureau must then report all follow-up actions and compliance status to the national medical device supervision department.