# China NMPA Drug Inspection - Jiangxi Pengshi Guoyaotang Pharmaceutical Co., Ltd. - Sophora tonkinensis

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/jiangxi-pengshi-guoyaotang-pharmaceutical-co-ltd/0b421670-6972-4568-b707-887caf8e082b/
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> China NMPA drug inspection for Jiangxi Pengshi Guoyaotang Pharmaceutical Co., Ltd. published May 09, 2018. Drug: Sophora tonkinensis. The Sichuan Provincial Food and Drug Administration issued an announcement on May 9, 2018, detailing the findings of its

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Sichuan Provincial Food and Drug Administration's Sichuan Provincial Drug Quality Bulletin (Second Issue of 2018)
- Company Name: Jiangxi Pengshi Guoyaotang Pharmaceutical Co., Ltd.
- Publication Date: 2018-05-09
- Drug Name: Sophora tonkinensis
- Inspection Finding: [Properties] [Identification] (Thin-layer chromatography)
- Action Taken: The municipal (prefecture-level) food and drug administration bureaus where the enterprises are located are required to investigate and prosecute the illegal acts of enterprises or units involved in the production, sale and use of substandard drugs in accordance with the relevant provisions of the "Drug Administration Law" and the "Regulations for the Implementation of the Drug Administration Law". The results of the handling shall be made public within three months and the relevant information shall be reported to the provincial bureau in a timely manner.
- Summary: The Sichuan Provincial Food and Drug Administration issued an announcement on May 9, 2018, detailing the findings of its provincial drug quality sampling inspections. These inspections, conducted across various drug production, distribution, and use units, aimed to enhance drug supervision and ensure the safety and efficacy of pharmaceutical products within the region.The inspections identified 26 batches of substandard drugs from multiple manufacturers and suppliers. Common violations included issues with "Properties," such as incorrect physical characteristics; "Inspection" parameters, frequently involving excessive sulfur dioxide residue, impurities, or moisture content; and failures in "Extractives" and "Identification" tests, indicating a deviation from established drug standards. For example, specific drugs like Epimedium and Salvia miltiorrhiza were found to contain impurities or excessive sulfur residue, while others like Yam and Small Tetrapanax failed property or identification criteria.Operating under the National Drug Sampling Management Measures and the provincial Drug Administration Law, the announcement mandates strict corrective actions. Local food and drug administration bureaus are required to investigate and prosecute the involved enterprises for their non-compliance. Furthermore, they must publicly disclose the investigation outcomes within three months and report all relevant information to the provincial authority, ensuring accountability and adherence to drug quality standards.

Company: https://www.globalkeysolutions.net/companies/jiangxi-pengshi-guoyaotang-pharmaceutical-co-ltd/782c387c-87f3-40bd-a42d-1870af0bf135/