China NMPA Drug Inspection - Gansu Zhongxiang Biotechnology Co., Ltd. - Qianhu

The Ningxia Food and Drug Administration announced the results of its 2017 regional drug sampling inspection on November 7, 2017, carried out under the "2017 Regional Drug Sampling Inspection Work Plan." The inspection focused on 18 batches across 16 varieties of traditional Chinese medicine (TCM) decoction pieces, with all batches found non-compliant with established quality standards. Key manufacturers whose products were implicated include Hebei Qixin Traditional Chinese Medicine Granules & Slices Co., Ltd., Hebei Anguo Zhenyu Pharmaceutical Co., Ltd., Anguo Changda Traditional Chinese Medicine Slices Co., Ltd., Baoji Hanfang Guoyao Pharmaceutical Co., Ltd., Beijing Bencao Fangyuan Pharmaceutical Co., Ltd., Gansu Guocao Pharmaceutical Co., Ltd., Pingliang Yongcheng Pharmaceutical Co., Ltd., Pingliang Zhukang Traditional Chinese Medicine Slices Co., Ltd., Pingliang Qingsong Traditional Chinese Medicine Pieces Co., Ltd., Lanzhou Xukang Pharmaceutical Co., Ltd., Gansu Zhongxiang Biotechnology Co., Ltd., Longxi Zhongtian Pharmaceutical Co., Ltd., and Hebei Yabao Pharmaceutical Co., Ltd. Violations ranged from issues with appearance (including counterfeit products and adulteration) to failures in specific tests for acid-insoluble ash, moisture content, active ingredient content (e.g., limonene), physicochemical and microscopic identification, thin-layer chromatography, extractives, ash content, and sulfur dioxide levels. These findings violated specifications outlined in the *Chinese Pharmacopoeia* (2010 and 2015 Editions, Part I) and the *Ningxia Traditional Chinese Medicine Processing Standards (1997 Edition)*. In response, relevant city and county market supervision administrations have initiated investigations and enforcement actions against the non-compliant drugs as per regulatory requirements.