# China NMPA Drug Inspection - Henan Fusen Pharmaceutical Co., Ltd. - Shuanghuanglian Injection

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/henan-fusen-pharmaceutical-co-ltd/2ba5acb3-dd35-4fd6-904f-eb829d88cc1f/
Source feed: China

> China NMPA drug inspection for Henan Fusen Pharmaceutical Co., Ltd. published November 05, 2021. Drug: Shuanghuanglian Injection. On November 5, 2021, the Gansu Provincial Drug Administration published the results of its third round of 2021 drug samp

---

## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Drug Quality Announcement from Gansu Provincial Drug Administration
- Company Name: Henan Fusen Pharmaceutical Co., Ltd.
- Publication Date: 2021-11-05
- Drug Name: Shuanghuanglian Injection
- Inspection Finding: The following inspection item is non-compliant and does not meet the requirements: [Inspection] (Pyrogen)
- Action Taken: The drug regulatory authorities have instructed relevant entities to implement risk control measures and to investigate and punish substandard products in accordance with relevant laws and regulations. The company submitted an objection and retested the retained samples from the same batch and 12 adjacent batches; all results met the requirements.
- Summary: On November 5, 2021, the Gansu Provincial Drug Administration published the results of its third round of 2021 drug sampling inspections, identifying five batches of pharmaceutical products that failed to meet required quality standards. The inspections, carried out by regional testing centers including the Jiuquan Municipal Drug Inspection and Testing Center, focused on both raw medicinal materials and finished injectable products. The four companies identified in the report are Lanzhou Xukang Pharmaceutical Co., Ltd., Zhangye Guangtai Medicinal Materials Co., Ltd., Gansu Fuxinghou Biomedical Technology Co., Ltd., and Henan Fusen Pharmaceutical Co., Ltd.

The violations involved failures in several critical quality categories. Issues included non-compliant physical properties in Typhae Pollen, insufficient active ingredient levels (trans-Anethole) in Fennel, and appearance defects in Poria Cocos. Most significantly, two batches of Shuanghuanglian Injection from Henan Fusen Pharmaceutical failed pyrogen testing, which checks for contaminants that cause fever. While Henan Fusen challenged the findings for one batch based on its own internal and third-party testing, the Gansu authorities maintained the non-compliant status in the official record.

The inspections were conducted under the regulatory framework of the Chinese Pharmacopoeia (2015 Edition), the Gansu Province Traditional Chinese Medicine Processing Standards (2009 Edition), and the Ministry of Health Drug Standards. Following these findings, the drug administration directed the relevant units to implement immediate risk control measures and process the substandard products according to provincial and national laws to ensure consumer safety.

Company: https://www.globalkeysolutions.net/companies/henan-fusen-pharmaceutical-co-ltd/3f732843-9d83-49bb-a790-2ca733151c2e/