# China NMPA Drug Inspection - Zhangzhou Jushantang Pharmaceutical Co., Ltd. - Northern Sophora root

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/zhangzhou-jushantang-pharmaceutical-co-ltd/016b9418-7179-446b-99a2-1fb4232684d5/
Source feed: China

> China NMPA drug inspection for Zhangzhou Jushantang Pharmaceutical Co., Ltd. published July 31, 2017. Drug: Northern Sophora root. The Fujian Province Drug Quality Announcement (Issue 6, 2017, Total Issue 67), published on July 31, 2017, reports on su

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Fujian Province Drug Quality Bulletin (Issue 6, 2017, Serial No. 67)
- Company Name: Zhangzhou Jushantang Pharmaceutical Co., Ltd.
- Publication Date: 2017-07-31
- Drug Name: Northern Sophora root
- Inspection Finding: The following items are not in compliance with the standard: Appearance and identification (1) Microscopic identification
- Action Taken: Food and drug regulatory authorities at all levels are organizing investigations and handling in accordance with the law.
- Summary: The Fujian Province Drug Quality Announcement (Issue 6, 2017, Total Issue 67), published on July 31, 2017, reports on supervision and sampling inspections conducted by provincial and municipal food and drug regulatory departments in Fujian, China. These inspections aimed to uphold public medication safety across drug production, distribution, and user units. The regulatory framework for these assessments was based on the "Drug Administration Law of the People's Republic of China" and various editions of the "Chinese Pharmacopoeia." Fifteen batches of drugs were identified as non-compliant with these established standards. Key manufacturers implicated in multiple non-compliances include Zhangzhou Jushantang Pharmaceutical Co., Ltd., Jiangxi Shunfutang Traditional Chinese Medicine Pharmaceutical Pieces Co., Ltd., and Zhangshu Qingren Traditional Chinese Medicine Slices Co., Ltd. The primary issues identified were unacceptable levels of "Sulfur Dioxide Residue" in several Traditional Chinese Medicine ingredients like Angelica sinensis, Moutan Cortex, and Yam Slices. Additional violations concerned product "Appearance," "Properties," and "Identification" (including microscopic identification and content determination) for items such as Sophora flavescens, Asarum sieboldii, Cicada Slough, Kudzu Root, and Madder. In response, regulatory departments are currently undertaking investigations and implementing appropriate legal actions for the non-compliant drugs and their respective units.

Company: https://www.globalkeysolutions.net/companies/zhangzhou-jushantang-pharmaceutical-co-ltd/e71d70ec-2a06-4bf2-a487-157e245ba436/