China NMPA Inspection - Yisheng Technology (Beijing) Co., Ltd. - April 26, 2017

An unannounced inspection report, published by the Beijing Municipal Food and Drug Administration on April 26, 2017, detailed significant compliance issues at Yisheng Technology (Beijing) Co., Ltd. The inspection revealed that the company's operational practices and overall quality management system exhibited deficiencies that did not conform to the stringent requirements of the Good Manufacturing Practice for Medical Devices. While specific details of the non-compliant actions were not enumerated in this summary, the report clearly indicated that the company's procedures fell short of the necessary standards for medical device manufacturing. These findings highlight a critical need for enhanced adherence to regulatory frameworks designed to ensure the quality and safety of medical products. Consequently, the Beijing Municipal Food and Drug Administration has formally instructed Yisheng Technology (Beijing) Co., Ltd. to undertake immediate and comprehensive corrective actions. The company is required to rectify all identified deficiencies within a specified period, thereby bringing its quality management system and manufacturing processes into full alignment with the Good Manufacturing Practice for Medical Devices to uphold public health standards.