# China NMPA Drug Inspection - Guangdong Dexin Pharmaceutical Co., Ltd. - Fuxue'an Tablets

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/guangdong-dexin-pharmaceutical-co-ltd/75877b7c-4c46-4f76-aa38-7f55d2d90055/
Source feed: China

> China NMPA drug inspection for Guangdong Dexin Pharmaceutical Co., Ltd. published April 09, 2021. Drug: Fuxue'an Tablets. On April 9, 2021, the Chongqing Municipal Drug Administration published an announcement detailing quality failures in 12

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement from Chongqing Municipal Drug Administration Regarding 12 Batches of Drugs That Failed to Meet Regulations
- Company Name: Guangdong Dexin Pharmaceutical Co., Ltd.
- Publication Date: 2021-04-09
- Drug Name: Fuxue'an Tablets
- Inspection Finding: Inspection (weight difference) did not meet the requirements
- Action Taken: Necessary control measures such as sealing, seizure, suspension of sales, and recall will be implemented, and the matter will be handled in accordance with relevant laws and regulations.
- Summary: On April 9, 2021, the Chongqing Municipal Drug Administration published an announcement detailing quality failures in 12 batches of drugs produced by 11 different companies. Key manufacturers involved include Sichuan Haobo Pharmaceutical Co., Ltd., Shenyang Hongyao Group Co., Ltd., Guangdong Dexin Pharmaceutical Co., Ltd., and Chengdu Qilong Traditional Chinese Medicine Pieces Co., Ltd. The findings were the result of organized sampling inspections conducted by various regional drug testing institutes to maintain market order and public safety.

The main violations cited in the report involve failures to meet strict quality specifications. Specific issues included identification discrepancies, such as thin-layer chromatography failures, and incorrect ingredient concentrations. Furthermore, several batches of traditional Chinese medicine pieces were found to contain organochlorine pesticide residues, while other tablet products failed to meet standard weight variation requirements. These products were assessed under the regulatory framework of the Chinese Pharmacopoeia (2015 Edition) and local provincial processing standards.

Following these results, the Chongqing Municipal Drug Administration has mandated immediate enforcement actions. These required actions include the sealing and seizure of non-compliant products, the total suspension of sales, and the mandatory recall of the affected batches. The administration will continue to handle these cases in accordance with relevant national laws and regulations to ensure future compliance.

Company: https://www.globalkeysolutions.net/companies/guangdong-dexin-pharmaceutical-co-ltd/000c2b6d-a6a3-4e9b-9f4c-5dce5e731b26/