# China NMPA Drug Inspection - Jiangxi Qirentang Traditional Chinese Medicine Pieces Co., Ltd. - Northern Sophora root

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/jiangxi-qirentang-traditional-chinese-medicine-pieces-co-ltd/a0b8ebab-3669-4454-a630-5cdfdbc76273/
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> China NMPA drug inspection for Jiangxi Qirentang Traditional Chinese Medicine Pieces Co., Ltd. published May 29, 2018. Drug: Northern Sophora root. On May 25, 2018, the Sichuan Provincial Food and Drug Administration issued an announcement detailing the outcomes of re

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Sichuan Provincial Food and Drug Administration's Sichuan Provincial Drug Quality Bulletin (Third Issue, 2018)
- Company Name: Jiangxi Qirentang Traditional Chinese Medicine Pieces Co., Ltd.
- Publication Date: 2018-05-29
- Drug Name: Northern Sophora root
- Inspection Finding: [Properties] [Identification] ((1) Microscopic identification, (2) Thin-layer chromatography) [Content determination] (Bat kuslinine and bat kuslinine)
- 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: On May 25, 2018, the Sichuan Provincial Food and Drug Administration issued an announcement detailing the outcomes of recent drug quality inspections. Supervisory sampling inspections, carried out by various city and prefecture-level food and drug administrations, targeted multiple drug production, distribution, and use units across the province. These inspections were conducted in accordance with the National Drug Sampling Management Measures and provincial guidelines.

The inspections identified a total of 37 batches of substandard drugs from numerous manufacturers and distributors, including entities such as Sichuan Ziren Pharmaceutical Co., Ltd., Sichuan Haobo Pharmaceutical Co., Ltd., and Sichuan Fengyi Chinese Medicine Pieces Co., Ltd. Key violations predominantly involved quality control issues. These included incorrect content determination of active ingredients (e.g., Rosmarinic Acid, Puerarin), the presence of impurities (e.g., sulfur dioxide residue, excessive ash), and failures in identification or properties tests. These non-compliances were assessed against the standards outlined in the Chinese Pharmacopoeia and, for certain items, the Sichuan Province Traditional Chinese Medicine Pieces Processing Specification.

As a result, the local food and drug administration bureaus overseeing the implicated enterprises are mandated to investigate and prosecute these illegal activities in strict adherence to the Drug Administration Law and its implementing regulations. They are required to publicly release the results of their investigations within three months and promptly report relevant information to the provincial bureau. This initiative underscores a commitment to strengthening drug supervision and safeguarding the safe and effective use of medications.

Company: https://www.globalkeysolutions.net/companies/jiangxi-qirentang-traditional-chinese-medicine-pieces-co-ltd/bc7f8cb1-0f93-4edf-8db9-836c24e4fc31/