# China NMPA Drug Inspection - Jinniu Central Pharmacy, Guoyao Chunwei Chain Co., Ltd., Daye City, Hubei Province - Coptis chinensis

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/jinniu-central-pharmacy-guoyao-chunwei-chain-co-ltd-daye-city-hubei-province/6bf11035-cd96-48c6-998c-0d42a5cf846b/
Source feed: China

> China NMPA drug inspection for Jinniu Central Pharmacy, Guoyao Chunwei Chain Co., Ltd., Daye City, Hubei Province published October 31, 2019. Drug: Coptis chinensis. The Hubei Province Drug Quality Bulletin (Issue 4, 2016), published on March 22, 2017, details findings from comprehensi

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Hubei Province Drug Quality Bulletin (Issue 4, 2016)
- Company Name: Jinniu Central Pharmacy, Guoyao Chunwei Chain Co., Ltd., Daye City, Hubei Province
- Publication Date: 2019-10-31
- Drug Name: Coptis chinensis
- Inspection Finding: The product's properties were substandard, and upon verification, it was found that it was not manufactured by the company indicated on the label.
- Action Taken: Local food and drug administration departments must investigate and punish substandard drugs and related entities in accordance with the law, strengthen follow-up sampling and testing, trace the source of problematic products, and transfer cases suspected of crimes to public security organs.
- Summary: The Hubei Province Drug Quality Bulletin (Issue 4, 2016), published on March 22, 2017, details findings from comprehensive drug quality sampling inspections conducted across various pharmaceutical production, operation, and use units in Hubei Province during the fourth quarter of 2016. A total of 144 drug batches were identified as non-compliant with established standards.

Main violations encompassed traditional Chinese medicinal herbs (processed pieces), medical institution preparations, and other pharmaceutical preparations. Common issues included failures in properties, identification (e.g., microscopic characteristics, thin-layer chromatography), and examination for impurities like sulfur dioxide residue, total ash, and moisture content. A significant and recurrent problem identified was product authenticity, with numerous instances where the indicated manufacturer denied production, could not be verified, or had their production license revoked, highlighting severe supply chain integrity concerns.

Regulatory assessments were based on the Chinese Pharmacopoeia (2010 and 2015 editions), Hubei Provincial Standards for Traditional Chinese Medicine Quality, and various national and Ministry of Health drug standards. Required actions include thorough investigations by local food and drug administration departments, increased follow-up sampling, tracing the source of non-compliant products, and referring suspected criminal cases to public security organs for prosecution, underscoring a commitment to reinforcing drug quality and supply chain control.

Company: https://www.globalkeysolutions.net/companies/jinniu-central-pharmacy-guoyao-chunwei-chain-co-ltd-daye-city-hubei-province/32e58c63-9101-4c52-8d6e-b69352e085e4/