# China NMPA Drug Inspection - Jiangxi Zhangshu Gexuan Traditional Chinese Medicine Pieces Co., Ltd. - Notopterygium

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/jiangxi-zhangshu-gexuan-traditional-chinese-medicine-pieces-co-ltd/28e11d40-fd15-44df-9398-a1b3e53e0a1b/
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> China NMPA drug inspection for Jiangxi Zhangshu Gexuan Traditional Chinese Medicine Pieces Co., Ltd. published July 20, 2018. Drug: Notopterygium. The National Medical Products Administration (NMPA) released an announcement on July 20, 2018, detailing significant qua

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 63 of 2018 from the National Medical Products Administration regarding 14 batches of drugs that did not meet the requirements.
- Company Name: Jiangxi Zhangshu Gexuan Traditional Chinese Medicine Pieces Co., Ltd.
- Publication Date: 2018-07-20
- Drug Name: Notopterygium
- Inspection Finding: The content determination did not meet the requirements (volatile oil, citronellol, and isoimperatorin).
- Action Taken: Relevant drug regulatory authorities have taken control measures such as sealing and seizing, requiring enterprises to suspend sales and use, recall products, and rectify the situation. Relevant provincial drug regulatory authorities have initiated investigations into the aforementioned enterprises and units for their illegal production and sale of counterfeit and substandard drugs in accordance with Articles 73, 74, and 75 of the "Drug Administration Law of the People's Republic of China," and will complete the investigation and handling of the relevant enterprises or units within three months from the date of receiving the inspection report and publicly disclose the results.
- Summary: The National Medical Products Administration (NMPA) released an announcement on July 20, 2018, detailing significant quality and safety deviations across 14 batches of drugs produced by 13 different manufacturers. The inspections, conducted by six drug testing institutions, revealed various non-compliance issues with national drug standards. Prominent violations included Shaanxi Hanwang Pharmaceutical Co., Ltd.'s Muxiang Shunqi Pills and several batches of Qianghuo from multiple companies failing appearance standards. Jiangxi Decheng Pharmaceutical Co., Ltd.'s Compound Dexamethasone Acetate Cream, along with other products, exhibited issues with content determination and fill volume. Solubility was compromised in Shilintong Granules by Sichuan Ziren Pharmaceutical Co., Ltd., while Jianmin Pharmaceutical Group Co., Ltd.'s Xiaojin Capsules exceeded microbial limits. Furthermore, Chifeng Weikang Biochemical Pharmaceutical Co., Ltd. and Gansu Xifeng Pharmaceutical Co., Ltd. had content determination problems with Vitamin U Belladonna Aluminum Capsules, and Zhejiang Huidisen Pharmaceutical Co., Ltd.'s Latamoxef Sodium for Injection showed elevated related substances. These failures contravene standards outlined in the Pharmacopoeia of the People's Republic of China and other national regulations. As a result, authorities initiated immediate control measures including product recalls, sales suspensions, and seizures. The NMPA directed provincial drug regulatory bodies to investigate these entities for producing and distributing substandard drugs, citing Articles 73, 74, and 75 of the Drug Administration Law of the People's Republic of China. These investigations are mandated for completion, with public disclosure of findings, within three months, underscoring a commitment to consumer safety and regulatory enforcement.

Company: https://www.globalkeysolutions.net/companies/jiangxi-zhangshu-gexuan-traditional-chinese-medicine-pieces-co-ltd/a908196d-ffd2-4858-ba1e-704b7ca5cc7d/