China NMPA Drug Inspection - Chongqing Grelin Pharmaceutical Co., Ltd. - Ginseng and Atractylodes Macrocephala Powder
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On February 9, 2018, the Henan Provincial Food and Drug Administration announced findings regarding four batches of substandard drugs from various manufacturers in China. This regulatory action followed tests conducted by several local drug inspection agencies, with the Chinese Pharmacopoeia 2015 Edition, Part I, serving as the primary regulatory framework for assessing product quality. The identified deficiencies pertained to specific quality attributes for traditional Chinese medicine products. Bozhou Jingwan Traditional Chinese Medicine Pieces Factory's Wujiapi (五加皮) was found to have substandard extractives. Anhui Yiyuantang Traditional Chinese Medicine Pieces Technology Co., Ltd. produced stir-fried Atractylodes lancea with non-compliant moisture and content levels. Hubei Daodi Medicinal Materials Technology Co., Ltd.'s safflower product exceeded impurity limits. Lastly, Chongqing Grelin Pharmaceutical Co., Ltd.'s Ginseng and Atractylodes Macrocephala Powder was found to contain excessive moisture. In response, the Henan Provincial Food and Drug Administration mandated immediate risk control measures. These included sealing, seizing, and suspending sales of the identified substandard drugs. Regulatory departments were further instructed to investigate and legally penalize the entities responsible for distributing these non-compliant products to ensure public safety and adherence to quality standards.
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