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

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/yuncheng-fenglingdu-development-zone-huachang-pharmaceutical-co-ltd/82679fab-3a09-44c8-9a64-3425c178c649/
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> China NMPA drug inspection for Yuncheng Fenglingdu Development Zone Huachang Pharmaceutical Co., Ltd. published October 23, 2015. Drug: Corydalis. This State Food and Drug Administration (SFDA) announcement, dated October 23, 2015, reports findings from a recent nati

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 78 of 2015 from the State Food and Drug Administration regarding the detection of auramine O in 9 batches of Chinese medicinal materials and prepared slices of Chinese medicinal herbs.
- Company Name: Yuncheng Fenglingdu Development Zone Huachang Pharmaceutical Co., Ltd.
- Publication Date: 2015-10-23
- Drug Name: Corydalis
- Inspection Finding: Auramine O was detected; this does not comply with the requirements of Part I of the 2010 edition of the Chinese Pharmacopoeia (properties and microscopic identification).
- Action Taken: Relevant provincial (regional) food and drug regulatory departments have taken control measures in accordance with the law, including sealing and seizing products, suspending production, and requiring companies to recall products. They have also been instructed to further investigate and deal with the matter seriously; cases suspected of constituting crimes must be promptly transferred to public security organs for criminal prosecution. The Shanxi Provincial Food and Drug Administration has been required to thoroughly investigate the source of the substandard Corydalis rhizome products from this company.
- Summary: This State Food and Drug Administration (SFDA) announcement, dated October 23, 2015, reports findings from a recent nationwide supervision and sampling inspection of Chinese medicinal materials and prepared Chinese medicinal herbs. The inspection revealed nine batches of products contaminated with Auramine O, a toxic chemical dye illegally used and prohibited in drug production. Several companies were implicated, including Anguo Wanlian, Anhui Yiyuantang, Anhui Hukun, Bozhou Changsheng, Bozhou Gongyao Pieces Factory, Sinopharm Holdings Guangxi, and Anguo Huifa Traditional Chinese Medicine Pieces Processing Co., Ltd. Their Phellodendron bark and Corydalis rhizome products tested positive for Auramine O. Additionally, Corydalis rhizome sold by Yuncheng Fenglingdu Development Zone Huachang Pharmaceutical Co., Ltd., a non-drug enterprise, was found to be substandard. Notably, some manufacturers denied producing the non-compliant batches, indicating potential supply chain integrity issues. Operating under the SFDA's drug quality control framework, provincial regulatory departments were directed to promptly implement control measures, including product sealing, seizure, production suspension, and recalls. The SFDA mandated thorough investigations into the involved entities and their supply chains, with serious violations or suspected criminal offenses to be referred to public security organs. All provincial administrations were required to submit their investigation and handling results to the SFDA by November 15, 2015, for public release, ensuring accountability and addressing these significant drug safety breaches.

Company: https://www.globalkeysolutions.net/companies/yuncheng-fenglingdu-development-zone-huachang-pharmaceutical-co-ltd/386f9481-7da6-4994-a0da-0c9327de7ead/