# China NMPA Drug Inspection - Zhongxiang Second People"s Hospital Zhuandou Branch - Bupleurum

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/zhongxiang-second-peoples-hospital-zhuandou-branch/0ae7c3c2-28a0-45cd-b46e-487779a5a925/
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> China NMPA drug inspection for Zhongxiang Second People"s Hospital Zhuandou Branch published November 28, 2019. Drug: Bupleurum. This Hubei Province Drug Quality Bulletin, published in July 2016 and covering the first quarter of that year, details e

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Hubei Province Drug Quality Bulletin (Issue 1, 2016)
- Company Name: Zhongxiang Second People"s Hospital Zhuandou Branch
- Publication Date: 2019-11-28
- Drug Name: Bupleurum
- Inspection Finding: Properties and identification (thin-layer chromatography)
- Action Taken: Food and drug administration departments in all cities (prefectures) should investigate and deal with the matter in accordance with relevant laws and regulations on drug supervision, and increase the intensity of follow-up sampling and testing of substandard drugs; for counterfeit drugs announced, their source should be traced to clarify the purchase and sales channels, and those suspected of committing crimes should be transferred to the public security department for investigation and handling in accordance with the law.
- Summary: This Hubei Province Drug Quality Bulletin, published in July 2016 and covering the first quarter of that year, details extensive quality control failures across numerous pharmaceutical entities. The regulatory body, Hubei Provincial Food and Drug Administration, conducted sampling inspections throughout the province, identifying 185 batches of non-compliant drugs. The issues spanned both Chinese Medicinal Herbs (Processed Pieces) and various customized dosage forms. For herbal products, violations included incorrect physical properties, identification discrepancies (e.g., microscopic characteristics, thin-layer chromatography), excessive moisture, impurities, ash content, and insufficient active compound levels. A significant concern was the prevalence of products either not manufactured by the indicated company, from companies with cancelled licenses, or from untraceable sources. Finished drug products, such as capsules, injections, and tablets, demonstrated issues including improper moisture levels, color variations in solutions, unacceptable impurity profiles, and deviations in dosage or weight. The regulatory framework cited for these non-compliances primarily includes the Chinese Pharmacopoeia 2010 Edition and various supplementary national and provincial drug standards. In response, local food and drug administration departments are mandated to investigate and enforce compliance, increase follow-up inspections, trace the origins of substandard or counterfeit drugs, and refer any suspected criminal activities to law enforcement. This bulletin underscores a critical need for enhanced quality assurance and supply chain integrity within the regional pharmaceutical sector.

Company: https://www.globalkeysolutions.net/companies/zhongxiang-second-peoples-hospital-zhuandou-branch/53e333f0-be01-4f65-9e3b-c1f092241e24/