# China NMPA Drug Inspection - Jiangxi Zhongshan Pharmaceutical Co., Ltd. - Heat-clearing and detoxifying oral liquid

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/jiangxi-zhongshan-pharmaceutical-co-ltd/610aa2ce-e6f6-40c2-b3f7-937946271fb0/
Source feed: China

> China NMPA drug inspection for Jiangxi Zhongshan Pharmaceutical Co., Ltd. published December 14, 2022. Drug: Heat-clearing and detoxifying oral liquid. On December 14, 2022, China's National Medical Products Administration (NMPA) issued Announcement No. 57, detailing eigh

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: National Medical Products Administration Announcement No. 57 of 2022 Regarding 8 Batches of Drugs That Did Not Meet Regulations
- Company Name: Jiangxi Zhongshan Pharmaceutical Co., Ltd.
- Publication Date: 2022-12-14
- Drug Name: Heat-clearing and detoxifying oral liquid
- Inspection Finding: The presence of Lonicera japonica saponin B was detected, exceeding the limit value.
- Action Taken: Enterprises are required to take risk control measures such as suspending sales and use, and recalling products; investigate and rectify the reasons for non-compliance; and initiate investigations.
- Summary: On December 14, 2022, China's National Medical Products Administration (NMPA) issued Announcement No. 57, detailing eight batches of drugs that failed to meet quality standards during recent inspections. The targeted companies included Furen Pharmaceutical Group Co., Ltd., Jiangxi Zhongshan Pharmaceutical Co., Ltd., Good Doctor Pharmaceutical Group Co., Ltd., Anhui Hongkun Pharmaceutical Co., Ltd., Anhui Yuankang Traditional Chinese Medicine Pieces Co., Ltd., and Anhui Fangshi Pharmaceutical Co., Ltd. The main violations centered on chemical and physical testing discrepancies. Notably, several oral liquids contained excessive levels of specific saponins, suggesting the unapproved use of wild honeysuckle instead of regulated species. Other issues involved failed content determination for active ingredients and non-compliance in physical appearance and microscopic identification for traditional Chinese medicinal products like peach kernels and madder root. These failures suggest potential issues with species authenticity, manufacturing processes, or storage conditions. Under the regulatory framework of the Drug Administration Law of the People's Republic of China and the Chinese Pharmacopoeia, the NMPA has mandated immediate risk control measures. The manufacturers must suspend sales, stop use, and initiate product recalls for all affected batches. Additionally, the companies are required to investigate the root causes of these quality failures and implement corrective actions. Provincial authorities will further investigate suspected illegal activities and publish the findings to ensure industry accountability and public safety.

Company: https://www.globalkeysolutions.net/companies/jiangxi-zhongshan-pharmaceutical-co-ltd/fef64ac1-a998-41eb-a93b-e76b9168961e/