# China NMPA Drug Inspection - Anhui Yishengyuan Traditional Chinese Medicine Pieces Technology Co., Ltd. - Huangbai

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/anhui-yishengyuan-traditional-chinese-medicine-pieces-technology-co-ltd/f3252371-26c7-439f-82d9-9465c5d001cb/
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> China NMPA drug inspection for Anhui Yishengyuan Traditional Chinese Medicine Pieces Technology Co., Ltd. published October 23, 2015. Drug: Huangbai. 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: Anhui Yishengyuan Traditional Chinese Medicine Pieces Technology Co., Ltd.
- Publication Date: 2015-10-23
- Drug Name: Huangbai
- Inspection Finding: Auramine O was detected
- Action Taken: The relevant provincial (regional) food and drug regulatory authorities have taken control measures in accordance with the law, such as sealing and seizing, suspending production, and requiring enterprises to recall products. They have also been required to further investigate and deal with the cases seriously. If a crime is suspected, the case should be transferred to the public security organs in a timely manner to pursue criminal liability.
- 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/anhui-yishengyuan-traditional-chinese-medicine-pieces-technology-co-ltd/c2292c5b-5423-41d2-824e-557e75208bc9/