China NMPA Drug Inspection - Jiyuan Jishi Pharmaceutical Co., Ltd., Henan Province - earth dragon

The Henan Provincial Food and Drug Administration published its 2016 Drug Quality Announcement on November 3, 2016, detailing results from province-wide supervision and sampling inspections. These inspections aimed to bolster drug quality oversight and safeguard public medication safety. The primary issues identified included serious instances of counterfeit products, notably Atorvastatin Calcium Tablets attributed to Pfizer Pharmaceuticals Co., Ltd., and Clopidogrel Bisulfate Tablets linked to Sanofi (Hangzhou) Pharmaceutical Co., Ltd. Beyond counterfeiting, numerous other drug products, from various manufacturers including Hubei Qianjiang Pharmaceutical Co., Ltd. and several traditional Chinese medicine ingredient suppliers like Yuzhou Kaixuan Pharmaceutical Co., Ltd., were found to be substandard. Violations encompassed critical failures in identification (e.g., thin-layer chromatography, liquid chromatography), inadequate content determination, unacceptable particle size, and issues with physical characteristics, appearance, or impurity levels in herbal preparations. Operating under the "Drug Administration Law of the People's Republic of China," the announcement mandates local authorities to thoroughly investigate all reported non-compliance. Required actions involve addressing the identified violations and implementing appropriate enforcement measures against manufacturers and distributors of substandard or counterfeit drugs to ensure public health and uphold drug quality standards.