China NMPA Drug Inspection - Shanghai Dedatang Traditional Chinese Medicine Co., Ltd. - Polygala tenuifolia (processed Polygala tenuifolia)

The Shanghai Municipal Drug Administration released its 2019 Issue 6 Drug Quality Sampling Inspection Announcement on July 30, 2019, following inspections conducted to uphold drug quality and market order. The announcement identified 42 batches of non-compliant drug products, predominantly Traditional Chinese Medicine (TCM) decoction pieces and a few medical institution preparations. Multiple manufacturers were implicated, including Anhui Wansheng Traditional Chinese Medicine Pieces Co., Ltd., Anhui Yijiantang Traditional Chinese Medicine Pieces Technology Co., Ltd., Tianma (Anhui) National Pharmaceutical Technology Co., Ltd., and Tongling Hetian Traditional Chinese Medicine Pieces Co., Ltd., among others, alongside preparations from Shanghai Ninth People's Hospital and Huashan Hospital.Violations were diverse, frequently involving discrepancies in "Properties" (e.g., appearance, insect infestation) and "Processing" standards. Other critical issues included inaccuracies in "Content Determination," excessive "Moisture Content," elevated "Total Ash" and "Acid-Insoluble Ash," and the presence of prohibited substances like "Sulfur Dioxide Residue," the dyeing agent "Auramine O," and the carcinogen "Aflatoxin." These findings were assessed against the 2015 Chinese Pharmacopoeia, 2008 Shanghai Processing Regulations, and other specific health administration standards.In response, regulatory bodies have mandated that affected companies and units implement control measures, including suspending sales, usage, or recalling products based on risk assessment. Furthermore, they are required to investigate the underlying causes of non-compliance and take necessary actions to mitigate future risks, ensuring public safety and product integrity.