China NMPA Drug Inspection - Shaanxi Renkang Pharmaceutical Co., Ltd. - Stir-fried Atractylodes lancea

The Shaanxi Provincial Food and Drug Administration published an announcement on March 6, 2018, detailing the results of its "2018 Third Quarter Sampling Inspection." This regulatory action involved drug quality inspections conducted across the province to safeguard public health. The inspections identified 18 batches of drugs from multiple manufacturers that failed to meet established quality standards. Key manufacturers whose products were found non-compliant include Ningxian Kang Shengyuan Pharmaceutical Co., Ltd., Pingliang Qingsong Traditional Chinese Medicine Pieces Co., Ltd., Beijing Tongrentang (Bozhou) Pharmaceutical Pieces Co., Ltd., and several other pharmaceutical and traditional Chinese medicine pieces companies. The main violations discovered pertained to critical quality parameters, specifically "properties" (physical characteristics), "identification" (authenticity verification), general "inspection" criteria, "content determination" (active ingredient strength), and "extractives" (soluble component levels). These non-conformities indicate failures in drug quality control. The regulatory framework used for assessment primarily comprised the "Chinese Pharmacopoeia 2015 Edition" and "Shaanxi Provincial Standards for Traditional Chinese Medicine Decoction Pieces." As a direct consequence, municipal and county-level food and drug regulatory departments have implemented necessary control measures concerning the implicated units. Investigations are currently in progress, and appropriate legal and regulatory actions will be enforced to address these violations and ensure the safety and efficacy of medicinal products available to the public.