# China NMPA Drug Inspection - Gansu Xuanyuan Pharmaceutical Development Co., Ltd. - alum

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/gansu-xuanyuan-pharmaceutical-development-co-ltd/ac89a5d3-244e-4c84-bc55-3921cfd5ceb3/
Source feed: China

> China NMPA drug inspection for Gansu Xuanyuan Pharmaceutical Development Co., Ltd. published October 15, 2018. Drug: alum. The Gansu Provincial Food and Drug Administration, operating under China's National Medical Products Administration fram

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Gansu Provincial Food and Drug Administration Drug Quality Announcement
- Company Name: Gansu Xuanyuan Pharmaceutical Development Co., Ltd.
- Publication Date: 2018-10-15
- Drug Name: alum
- Inspection Finding: examine
- Action Taken: Relevant food and drug administration departments have taken control measures such as sealing and seizing, requiring enterprises to suspend the sale and use of products and to rectify the situation. The municipal (prefecture-level) food and drug administration departments where the sampled products are located should, in accordance with Articles 73, 74, and 75 of the "Drug Administration Law of the People's Republic of China," investigate and prosecute illegal activities involving the production and sale of counterfeit and substandard drugs, and publicly disclose the results of the handling of relevant enterprises or units that produced and sold substandard drugs within three months.
- Summary: The Gansu Provincial Food and Drug Administration, operating under China's National Medical Products Administration framework, released an announcement on October 15, 2018, detailing the outcomes of targeted supervision and sampling inspections. These inspections specifically focused on traditional Chinese medicine (TCM) decoction pieces, which had previously shown high rates of non-compliance. The initiative identified 11 batches of products from several companies, including Gansu Guocao Pharmaceutical Co., Ltd., Shaanxi Kangchao Kangjian Pharmaceutical Co., Ltd., Anhui Yiyuan Pharmaceutical Co., Ltd., Pingliang Zhukang Traditional Chinese Medicine Pieces Co., Ltd., Gansu Xuanyuan Pharmaceutical Development Co., Ltd., Baoji Xiangyuan Traditional Chinese Medicine Slices Co., Ltd., Baoji Hanfang Pharmaceutical Co., Ltd., and Gansu Lanya Pharmaceutical Co., Ltd., that failed to meet quality standards. Key violations included deficiencies in content determination (e.g., for Cattail Pollen, Kudzu Root, Licorice), improper moisture content (Alum), and non-compliance with product properties or impurity limits (Lysimachia christinae, Typha Pollen). These assessments were conducted based on standards outlined in the Chinese Pharmacopoeia (2010 and 2015 Editions) and the Gansu Provincial Standard for Traditional Chinese Medicine 2009 Edition, all within the regulatory framework of the "Drug Administration Law of the People's Republic of China." Required actions included immediate control measures like seizing and sealing non-compliant products, mandating enterprises to suspend sales and usage, and initiate rectification. Furthermore, local food and drug administrations were instructed to conduct thorough investigations into illegal activities and publicly disclose the findings for involved companies within three months to enhance drug quality and public safety.

Company: https://www.globalkeysolutions.net/companies/gansu-xuanyuan-pharmaceutical-development-co-ltd/53cf4073-32d8-4b32-878f-214de8c4652a/