China NMPA Inspection - Tianjin Yangquan Medical Equipment Co., Ltd. - June 23, 2017

An unannounced inspection conducted by the State Food and Drug Administration (SFDA) from May 9-11, 2017, identified significant deficiencies at Tianjin Yangquan Medical Device Co., Ltd., a manufacturer of disposable hemoperfusion devices. The inspection was carried out under the "Measures for Unannounced Inspections of Drugs and Medical Devices" and evaluated the company's compliance with "Good Manufacturing Practice for Medical Devices" and its "Appendix: Sterile Medical Devices." Key violations centered on serious problems within the company's production quality management system. Specifically, inspectors found a lack of a suitable hazardous materials storage area for anhydrous ethanol, which is used in large quantities (approximately 2 tons monthly). Ethanol was reportedly stored in a workshop passageway designated as "Temporary Ethanol Storage," with no dedicated hazardous materials facility identified. Furthermore, a substantial discrepancy in raw material inventory was discovered: approximately 90 tons of resin, purchased in 2012, were unaccounted for in the material requisition ledger, despite a 100-ton purchase contract. As a result, Tianjin Yangquan Medical Device Co., Ltd. has been ordered to immediately cease production for comprehensive rectification. The company must address all identified deficiencies, including those related to medical device registration management, and will only be permitted to resume operations after passing a subsequent follow-up inspection. The local regulatory commission is required to publish the company's suspension and rectification status. Additionally, the Tianjin Municipal Market and Quality Supervision and Management Commission is tasked with strengthening its daily oversight, increasing inspection frequency for problematic enterprises, and ensuring rigorous adherence to medical device manufacturing standards to safeguard product safety and effectiveness.