China NMPA Inspection - Jiangxi Zhangshu Gexuan Traditional Chinese Medicine Pieces Co., Ltd. - April 17, 2015

From March 25th to 27th, 2015, a joint inspection by the State Food and Drug Administration and the Jiangxi Provincial Food and Drug Administration uncovered significant compliance failures at Jiangxi Zhangshu Gexuan Traditional Chinese Medicine Pieces Co., Ltd. The inspection revealed two primary violations. First, the company is suspected of falsifying production and inspection records, as the capacity of their hot air circulating oven and high-performance liquid chromatograph (HPLC) did not align with the quantities and varieties of traditional Chinese medicine pieces being produced. Further investigation into HPLC usage records and personnel interviews corroborated these suspicions. Second, the company was found to be operating beyond its permitted scope, specifically producing and selling Heishun slices without the necessary authorization for processing toxic medicinal materials. These actions represent serious breaches of the "Drug Administration Law" and Good Manufacturing Practice (GMP) regulations. Consequently, the Jiangxi Provincial Food and Drug Administration has revoked the company's GMP certificate, ordered an immediate cessation of production, and mandated the recall of all affected products. Legal cases have been initiated to investigate and penalize these unlawful activities, with the potential for transfer to public security organs if criminal conduct is identified.