China NMPA Drug Inspection - Weifang Weicheng Economic Development Zone Hospital - Buzhong Yishen Capsules

The Shandong Provincial Food and Drug Administration announced on February 9, 2018, that nine batches of medical institution preparations from eight different facilities failed quality inspections. These inspections, conducted by five drug testing institutions including the Zibo Municipal Institute for Food and Drug Control and Weifang Municipal Food and Drug Inspection and Testing Center, revealed critical quality deficiencies. Key violations included product contamination in preparations from Zibo Municipal Traditional Chinese Medicine Hospital, Zibo Municipal Maternal and Child Health Hospital, Weifang Weicheng Economic Development Zone Hospital, and Jining Municipal Institute of Dermatology and Venereology. Additionally, four other institutions—Jining Vascular Disease Hospital, Yanzhou Jiuyi Hospital, Tai'an Second Traditional Chinese Medicine Hospital, and Yinan Panfeng Orthopedic Hospital—were cited for preparations found to be substandard in total amount. The affected products included various pills, oral solutions, capsules, and lotions, with batch numbers indicating production primarily in 2017. In response, the relevant municipal food and drug administration bureaus initiated control measures, including sealing, seizing, and suspending the sale of the non-compliant products. They are also investigating and addressing the issues with the implicated medical institutions in accordance with regulatory requirements. Furthermore, these bureaus are tasked with strengthening ongoing supervision, compelling institutions to identify root causes, implement corrective actions, and mitigate future risks to ensure patient safety and product quality.