China NMPA Drug Inspection - Jiangxi Dongfeng Pharmaceutical Co., Ltd. - Traumatic Injury and Blood Circulation Powder

The China Food and Drug Administration (CFDA) announced on December 7, 2016, critical findings from national drug sampling inspections. Six batches of drugs from five companiesJilin Yongli Pharmaceutical Co., Ltd., Jilin Dongfeng Pharmaceutical Co., Ltd., Jilin Shuangshi Pharmaceutical Co., Ltd., Jinhe Tibetan Medicine Co., Ltd., and Tibet Jinzhu Yalong Tibetan Medicine Co., Ltd.were found to contain unauthorized substances. Specifically, Dieda Huoxue San from Jilin Yongli, Jilin Dongfeng, and Jilin Shuangshi was contaminated with abietic acid (rosin acid), indicating potential raw material adulteration. Ershiwuwei Shanhu Wan from Jinhe Tibetan Medicine and Tibet Jinzhu Yalong Tibetan Medicine contained 808 scarlet, an illegal dye, suggesting potential raw material dyeing. These discoveries highlighted severe deficiencies in the companies' production quality management systems. Regulatory authorities, including provincial and regional Food and Drug Administrations, immediately implemented product control measures such as sealing, seizing, suspending sales, and initiating mandatory recalls. The CFDA mandated that the involved companies cease production of affected products, conduct thorough investigations into the root causes, and implement corrective actions before resuming operations. Further investigations and penalties under the "Drug Administration Law of the People's Republic of China" were ordered. This included tracing the origin of illegal raw materials and referring suspected criminal cases to public security organs, alongside public disclosure of all findings.