China NMPA Drug Inspection - Henan Xin Sifang Pharmaceutical Co., Ltd. - Atractylodes lancea

The Henan Provincial Food and Drug Administration issued an announcement on June 6, 2016, detailing the findings of its 2015-2016 drug supervision and sampling inspections across Henan Province. This initiative aimed to enhance drug quality oversight and safeguard public health.The inspections identified 28 substandard drug samples from multiple manufacturers, including Changzhou Kangpu Pharmaceutical, Jiangzhong Pharmaceutical, Qingdao Huanghai Pharmaceutical, and various traditional Chinese medicine producers like Anhui Yishengyuan Traditional Chinese Medicine Pieces Technology Co., Ltd. and Hunan Guhantang Ejiao Pharmaceutical Co., Ltd. Significant violations included the presence of counterfeit drugs such as Compound Diphenoxylate Tablets and Nifedipine Sustained-Release Tablets II. Other critical issues comprised failures in drug identification, incorrect content specifications, deviations in physical properties like disintegration time and weight, and unacceptable levels of impurities, such as sulfur dioxide residue in dried ginger. A notable concern in traditional Chinese medicine products like Tortoise Shell Glue and Deer Antler Glue was the misrepresentation or adulteration of animal-derived ingredients.In response to these findings, local authorities are mandated to investigate and take appropriate enforcement actions in accordance with the "Drug Administration Law of the People's Republic of China" and other pertinent regulations, ensuring accountability and improving drug quality standards.