China NMPA Drug Inspection - Shanghai Zhenrentang Pharmaceutical Co., Ltd. - Astragalus

The Shanghai Municipal Food and Drug Administration (Shanghai MFDA) issued an announcement on May 7, 2018, detailing the results of its drug supervision and sampling inspections conducted in 2018. These inspections aimed to bolster quality management, regulate market order, and ensure the safety of drugs and pharmaceutical packaging materials across production, operation, and use units in the city. Multiple entities, including manufacturers like Macheng Jiuzhou Traditional Chinese Medicine Development Co., Ltd., Anhui Wugeng Traditional Chinese Medicine Slices Co., Ltd., Shanghai Dehua Guoyao Products Co., Ltd., and Shanghai Tongjitang Pharmaceutical Co., Ltd., were cited for non-compliance. The inspections revealed significant issues primarily concerning traditional Chinese medicinal slices. Common violations included deficiencies in product appearance, improper processing methods, inaccurate content determination, and excessive sulfur dioxide residue. The regulatory framework underpinning these findings was predominantly the 2015 Edition Chinese Pharmacopoeia, alongside the 2008 Edition Shanghai Processing Regulations for specific items. In response to the unqualified products, the Shanghai MFDA mandated immediate suspension of sales and use, product recalls, and comprehensive rectification of identified problems. Furthermore, relevant regulatory departments were instructed to investigate and handle these cases legally, implement control measures, and strengthen follow-up inspections. Enterprises are required to investigate root causes, develop and execute corrective actions, and mitigate future risks.