# China NMPA Drug Inspection - Chengdu Xinfuyuan Traditional Chinese Medicine Pieces Co., Ltd. - Atractylodes lancea (stir-fried with wheat bran)

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/chengdu-xinfuyuan-traditional-chinese-medicine-pieces-co-ltd/f4511246-9316-4aec-afa2-a72c563745cb/
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> China NMPA drug inspection for Chengdu Xinfuyuan Traditional Chinese Medicine Pieces Co., Ltd. published August 20, 2018. Drug: Atractylodes lancea (stir-fried with wheat bran). The Sichuan Provincial Food and Drug Administration (NMPA) issued an announcement on August 14, 2018, detailing findings

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Sichuan Province Drug Quality Bulletin (Sixth Issue, 2018)
- Company Name: Chengdu Xinfuyuan Traditional Chinese Medicine Pieces Co., Ltd.
- Publication Date: 2018-08-20
- Drug Name: Atractylodes lancea (stir-fried with wheat bran)
- Inspection Finding: [Properties] [Content Determination] (Atractylodes lancea)
- Action Taken: The municipal (prefecture-level) food and drug administration bureau where the enterprise is located shall, in accordance with the relevant provisions of the "Drug Administration Law" and the "Regulations for the Implementation of the Drug Administration Law", investigate and punish the illegal acts of enterprises or units that produce, sell or use substandard drugs, disclose the results of the handling within three months, and report the relevant information to the provincial bureau in a timely manner.
- Summary: The Sichuan Provincial Food and Drug Administration (NMPA) issued an announcement on August 14, 2018, detailing findings from supervisory sampling inspections conducted by municipal (prefecture) food and drug administrations. This "Sixth Issue, 2018" bulletin identified 23 batches of substandard drugs from various pharmaceutical companies and distributors across the province. The inspections, which culminated in this 2018 announcement, revealed a range of quality control issues. Common violations included failures in drug properties, identification tests (such as thin-layer chromatography and microscopic features), and specific inspection parameters like total ash, sulfur dioxide residue, acid-insoluble ash, and water content. Furthermore, several batches failed content determination tests for active pharmaceutical ingredients, including naringin, Mongolian glycoside, volatile oil, puerarin, atractylodes lancea, honokiol, gentianin, and psoralen, indicating potential issues with efficacy or purity. These findings were made in accordance with the "National Drug Sampling Management Measures," "Sichuan Province's drug sampling work" requirements, and specific monographs from the "Chinese Pharmacopoeia." The regulatory framework for enforcement is based on the "Drug Administration Law" and its "Regulations for Implementation." As a result, the Provincial Administration mandated that the local food and drug administrations investigate and prosecute all illegal activities related to the production, sale, and use of these unqualified drugs. They are required to publicly disclose the handling results within three months and promptly report relevant information back to the Provincial Administration, ensuring accountability and safeguarding public health.

Company: https://www.globalkeysolutions.net/companies/chengdu-xinfuyuan-traditional-chinese-medicine-pieces-co-ltd/69a90b69-42d6-467b-8c0d-b0b97806df48/