# China NMPA Drug Inspection - Jilin Yimintang Pharmaceutical Co., Ltd. - An Shen Bu Xin Pian (a traditional Chinese medicine)

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/jilin-yimintang-pharmaceutical-co-ltd/fe01bc14-2edb-4fa8-99c6-e1ae726cdbec/
Source feed: China

> China NMPA drug inspection for Jilin Yimintang Pharmaceutical Co., Ltd. published November 02, 2018. Drug: An Shen Bu Xin Pian (a traditional Chinese medicine). The Guangxi Zhuang Autonomous Region Food and Drug Administration (part of China's National Medical Products Administrat

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Drug Quality Bulletin of Guangxi Zhuang Autonomous Region Food and Drug Administration (Issue 10, 2018)
- Company Name: Jilin Yimintang Pharmaceutical Co., Ltd.
- Publication Date: 2018-11-02
- Drug Name: An Shen Bu Xin Pian (a traditional Chinese medicine)
- Inspection Finding: Non-compliant - [Inspection] Weight variation
- Action Taken: The Guangxi Zhuang Autonomous Region Food and Drug Administration has organized relevant food and drug administrations to take necessary control measures for drugs that do not meet the standards, and is investigating and prosecuting them in accordance with relevant laws and regulations.
- Summary: The Guangxi Zhuang Autonomous Region Food and Drug Administration (part of China's National Medical Products Administration regulatory framework) issued its 10th Drug Quality Announcement of 2018 on November 2, 2018. This announcement followed a series of sampling inspections across drug production, distribution enterprises, and medical institutions, aimed at strengthening drug quality supervision and ensuring public medication safety.

The inspections identified five batches of drugs that failed to meet established quality standards. Specifically, three batches of drug preparations and two batches of traditional Chinese medicine decoction pieces were found to be non-compliant. Noteworthy violations included Shangqiu Jinma Pharmaceutical Co., Ltd.'s Yuanhu Zhitong Tablets, which had issues with appearance and film coating; Jilin Baixingtang Pharmacy Industry Co., Ltd.'s Anshen Buxin Tablets, found to have non-compliant tablet weight differences; and Donggeer Pharmaceutical Co., Ltd.'s Twenty-Five Flavors Ferula Capsules, which failed content uniformity tests. For traditional Chinese medicine, Guangxi Herbal Source Traditional Chinese Medicine Decoction Pieces Pharmaceutical Co., Ltd.'s Kudzu Root did not meet total ash content standards, and Nanning Weizhong Pharmaceutical Co., Ltd.'s Prepared Polygonum multiflorum Prepared Slices were non-compliant for anthraquinone levels.

These findings were evaluated against the 2015 edition of the Chinese Pharmacopoeia and specific product standards. In response, the Guangxi FDA has directed relevant local food and drug administrations to implement necessary control measures for the substandard drugs and to initiate investigations and enforcement actions in accordance with applicable Chinese laws and regulations.

Company: https://www.globalkeysolutions.net/companies/jilin-yimintang-pharmaceutical-co-ltd/9d7550b7-ee12-4fac-a920-2a7cd9892c6f/