# China NMPA Drug Inspection - Guangxi Huaxing Pharmaceutical and Medical Device Co., Ltd. - Xiangdan Injection

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/guangxi-huaxing-pharmaceutical-and-medical-device-co-ltd/f490351e-32dd-4d9d-9228-9863fda1c95b/
Source feed: China

> China NMPA drug inspection for Guangxi Huaxing Pharmaceutical and Medical Device Co., Ltd. published June 29, 2018. Drug: Xiangdan Injection. On June 29, 2018, the Guangxi Zhuang Autonomous Region Food and Drug Administration released its 6th Drug Quality Announ

---

## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Drug Quality Bulletin of Guangxi Zhuang Autonomous Region Food and Drug Administration (Issue 6, 2018)
- Company Name: Guangxi Huaxing Pharmaceutical and Medical Device Co., Ltd.
- Publication Date: 2018-06-29
- Drug Name: Xiangdan Injection
- Inspection Finding: Selling drugs that do not meet the standards
- Action Taken: Investigate and deal with according to law
- Summary: On June 29, 2018, the Guangxi Zhuang Autonomous Region Food and Drug Administration released its 6th Drug Quality Announcement, summarizing findings from routine drug quality sampling inspections. These inspections were conducted under the Guangxi drug sampling inspection plan, with the primary goal of ensuring public medication safety. The announcement highlighted a significant non-compliance issue involving one batch of Xiangdan Injection. The product, manufactured by Kaikai Yuansheng Pharmaceutical Co., Ltd., specifically batch number 1701211 (2ml per vial), was distributed by Guangxi Huaxing Pharmaceutical and Medical Device Co., Ltd. The main violation identified was the presence of visible foreign matter, a finding that contravened the quality standards set forth in the Chinese Pharmacopoeia 2015 Edition Part IV and the Ministry of Health Drug Standards Volume 17 (1998).

In response, the Guangxi Zhuang Autonomous Region Food and Drug Administration directed the Laibin City Food and Drug Administration to implement immediate and necessary control measures. These actions included sealing, seizing, and suspending the sale of the affected drugs. Additionally, a legal investigation and appropriate punitive actions are to be taken against the entities responsible for sourcing and distributing the non-compliant samples, with particular focus on Guangxi Huaxing Pharmaceutical and Medical Device Co., Ltd. This enforcement demonstrates the regulatory body's dedication to maintaining drug quality and protecting public health.

Company: https://www.globalkeysolutions.net/companies/guangxi-huaxing-pharmaceutical-and-medical-device-co-ltd/fe622e33-3d18-4505-a5bf-33808efd9eff/