# China NMPA Drug Inspection - Sichuan Tianyun Minkang Traditional Chinese Medicine Pieces Co., Ltd. - Akebia stem (processed Chinese medicinal herbs)

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/sichuan-tianyun-minkang-traditional-chinese-medicine-pieces-co-ltd/f000d536-e097-4bcf-b6c2-a89cad6b8772/
Source feed: China

> China NMPA drug inspection for Sichuan Tianyun Minkang Traditional Chinese Medicine Pieces Co., Ltd. published July 22, 2019. Drug: Akebia stem (processed Chinese medicinal herbs). The Sichuan Provincial Drug Administration released its Third Issue of the 2019 Drug Quality Bulletin on July 22, 2019, 

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Sichuan Province Drug Quality Bulletin (Third Issue, 2019)
- Company Name: Sichuan Tianyun Minkang Traditional Chinese Medicine Pieces Co., Ltd.
- Publication Date: 2019-07-22
- Drug Name: Akebia stem (processed Chinese medicinal herbs)
- Inspection Finding: [Characteristics] [Identification] [(1) Microscopic identification, (2) Thin-layer chromatography] Unqualified
- Action Taken: The sale and use of the products were suspended, the products were recalled, an investigation was conducted into the reasons for non-compliance, and thorough rectification measures were implemented.
- Summary: The Sichuan Provincial Drug Administration released its Third Issue of the 2019 Drug Quality Bulletin on July 22, 2019, announcing the results of recent sampling inspections conducted across various drug production, distribution, and use units in Sichuan Province. These inspections identified 44 batches of non-compliant drugs from multiple manufacturers and distributors.

The main violations encompassed a range of quality control deficiencies. These included issues with product "properties" (such as appearance and microscopic identification), failures in "content determination" of active ingredients, and deviations in parameters like "moisture" content, "pack weight difference," presence of "impurities," elevated "heavy metals" (specifically arsenic), unacceptable "pesticide residues," and non-conforming "extractives." The regulatory framework for these assessments primarily referenced the "Chinese Pharmacopoeia" (predominantly the 2015 Edition I) and relevant provincial Traditional Chinese Medicine processing specifications.

In response to these findings, the drug supervision and management departments have mandated several corrective actions. These include requiring the implicated enterprises to immediately "suspend sales and use" of the affected products, initiate "product recalls," conduct thorough "investigations into the reasons for non-compliance," and implement "earnest and thorough rectification" of the identified issues.

Company: https://www.globalkeysolutions.net/companies/sichuan-tianyun-minkang-traditional-chinese-medicine-pieces-co-ltd/acc3930c-7414-41f7-b975-efda320d5419/