China NMPA Drug Inspection - Gansu Kangshengtang Co., Ltd. - leech

The Gansu Provincial Drug Administration issued a Drug Quality Announcement on December 30, 2019, identifying significant quality deficiencies across 15 batches of drugs from 14 manufacturers. Led by Gansu Yalan Pharmaceutical Co., Ltd., the implicated companies failed to meet standards outlined in the Chinese Pharmacopoeia 2015 Edition, Part I. Key violations included deficiencies in quality control parameters such as elevated total aerobic bacteria count, issues with physical properties like appearance and pH, and purity concerns related to total ash, acid-insoluble ash, loss on ignition, and extractives. Some products also demonstrated non-compliance in content determination, and the presence of heavy metals and harmful elements. In response, regulatory authorities have implemented immediate control measures, including sealing and seizing the non-compliant products. Investigations into the responsible units have been initiated or are underway, with findings slated for public release within three months. Furthermore, municipal and prefectural market supervision bureaus are tasked with enhanced oversight, compelling the involved companies to thoroughly investigate the root causes, develop and execute rectification plans, and effectively mitigate future risks to ensure public safety and product integrity.