# China NMPA Drug Inspection - Jingzhou Jinfeng Pharmaceutical Development Co., Ltd. - Isatis root granules

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/jingzhou-jinfeng-pharmaceutical-development-co-ltd/6553734a-0baa-42cd-bac9-6eb36632f688/
Source feed: China

> China NMPA drug inspection for Jingzhou Jinfeng Pharmaceutical Development Co., Ltd. published October 24, 2017. Drug: Isatis root granules. On October 24, 2017, the Henan Provincial Food and Drug Administration announced findings regarding three batches of tra

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement from Henan Provincial Food and Drug Administration Regarding 3 Batches of Substandard Drugs Found in Spot Checks
- Company Name: Jingzhou Jinfeng Pharmaceutical Development Co., Ltd.
- Publication Date: 2017-10-24
- Drug Name: Isatis root granules
- Inspection Finding: Microbial limits not in compliance with regulations
- Action Taken: Risk control measures such as sealing, seizing, and suspending sales were implemented, and the units that sourced the inspected goods were investigated and punished in accordance with the law.
- Summary: On October 24, 2017, the Henan Provincial Food and Drug Administration announced findings regarding three batches of traditional Chinese medicines that failed quality standards. These issues were identified through inspections conducted by various municipal institutes, with testing based on the Chinese Pharmacopoeia (2015 and 2010 editions), serving as the core regulatory framework. Three companies were cited for specific deficiencies. Jilin Songliao Pharmaceutical Co., Ltd.'s product, Tongqiao Biyan Pian (batch 20161003), was deemed substandard due to its appearance. Jingzhou Jinfeng Pharmaceutical Development Co., Ltd.'s Banlangen Granules (batch 151106) failed to meet microbial limit requirements, indicating potential contamination. Additionally, Sichuan Fengchun Pharmaceutical Co., Ltd.'s Yimucao Granules (batch 161104) were non-compliant with solubility specifications, which could affect drug efficacy. In response to these violations, the Henan Provincial Food and Drug Administration instructed relevant regulatory departments to implement immediate risk control measures. These actions include sealing, seizing, and suspending the sales of the identified substandard drugs. Furthermore, the regulatory body mandated investigations and legal enforcement against the implicated manufacturers to ensure accountability and uphold public health and safety standards within the pharmaceutical sector.

Company: https://www.globalkeysolutions.net/companies/jingzhou-jinfeng-pharmaceutical-development-co-ltd/efc0a58e-91ec-499c-8c99-80508e13163c/