China NMPA Drug Inspection - Yuncheng Fenglingdu Development Zone Huachang Pharmaceutical Co., Ltd. - Corydalis

This document, an announcement from the State Food and Drug Administration (SFDA) dated October 23, 2015, details findings from a nationwide special supervision and sampling inspection of Chinese medicinal materials and prepared Chinese medicinal herbs. The primary issue identified was the illegal presence of Auramine O, a chemical dye with known toxic effects, in nine batches of products, which is strictly prohibited.Multiple pharmaceutical and traditional Chinese medicine processing companies were implicated, including Anguo Wanlian Traditional Chinese Medicine Pieces Co., Ltd., Anhui Yiyuantang Traditional Chinese Medicine Pieces Technology Co., Ltd., Anhui Hukun Traditional Chinese Medicine Pieces Co., Ltd., Bozhou Changsheng Traditional Chinese Medicine Pieces Co., Ltd., Bozhou Gongyao Pieces Factory, Sinopharm Holdings Guangxi Traditional Chinese Medicine Pieces Co., Ltd., and Anguo Huifa Traditional Chinese Medicine Pieces Processing Co., Ltd. Additionally, Yuncheng Fenglingdu Development Zone Huachang Pharmaceutical Co., Ltd., a non-drug enterprise, was cited for selling non-compliant products. The affected materials included Phellodendron bark and Corydalis rhizome.The SFDA mandated that provincial regulatory bodies implement immediate control measures, such as sealing products, suspending production, and recalling affected batches. Further rigorous investigations into the involved entities are required, with severe penalties for violations and potential criminal prosecution for suspicious cases. Provincial administrations in Shanxi, Fujian, and Anhui received specific directives to investigate product origins, verify manufacturing claims, and report findings by November 15, 2015, ensuring public disclosure. This enforcement action underscores the SFDA's commitment to upholding drug quality and consumer safety against illegal adulteration.