China NMPA Inspection - Shandong March 3rd Gene Technology Co., Ltd. - April 11, 2017

An important report released by the National Medical Products Administration (NMPA) on April 11, 2017, detailed findings from an unannounced inspection of Shandong Sanyuesan Gene Technology Co., Ltd. The inspection revealed that the company's operations did not adhere to the relevant requirements of the Good Manufacturing Practice for Medical Devices. Specifically, significant deficiencies were identified within its quality management system. The regulatory framework governing this inspection is the Good Manufacturing Practice for Medical Devices, which outlines the standards for manufacturing quality and safety. As a result of these findings, the Shandong Provincial Food and Drug Administration issued a directive to Shandong Sanyuesan Gene Technology Co., Ltd., mandating the rectification of all identified deficiencies within a specified timeframe to ensure compliance with regulatory standards.