# China NMPA Drug Inspection - Changchun Zhonghe Pharmaceutical Co., Ltd. - Gentiana macrophylla

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/changchun-zhonghe-pharmaceutical-co-ltd/cd804820-192d-44a1-b832-cc4076376139/
Source feed: China

> China NMPA drug inspection for Changchun Zhonghe Pharmaceutical Co., Ltd. published October 29, 2020. Drug: Gentiana macrophylla. On October 29, 2020, the National Medical Products Administration (NMPA) issued Announcement No. 73, identifying 18 batc

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 73 of 2020 from the National Medical Products Administration regarding 18 batches of drugs that did not meet the requirements.
- Company Name: Changchun Zhonghe Pharmaceutical Co., Ltd.
- Publication Date: 2020-10-29
- Drug Name: Gentiana macrophylla
- Inspection Finding: [Inspect] (Impurities)
- Action Taken: Suspension of sales and use, recall, investigation and rectification, and filing of a case for investigation.
- Summary: On October 29, 2020, the National Medical Products Administration (NMPA) issued Announcement No. 73, identifying 18 batches of medications from 11 pharmaceutical companies that failed to meet national quality standards. Key manufacturers cited include Guizhou Diyi Health Pharmaceutical Co., Ltd., Ruiyang Pharmaceutical Co., Ltd., Jilin Yizheng Pharmaceutical Group Co., Ltd., and Yunnan Botanical Pharmaceutical Co., Ltd. Testing conducted by several provincial institutes revealed various quality failures. Compound Acetaminophen Tablets were found with excessive impurities and poor disintegration rates. Other issues identified across different products included microbial contamination, visible foreign matter in injections, and poor solution clarity. Traditional Chinese medicinal pieces also failed standards for purity, appearance, and identification characteristics. Under the 'Drug Administration Law of the People's Republic of China,' the NMPA has mandated immediate risk control measures. Affected companies must suspend the sale and use of these batches and initiate comprehensive product recalls. Furthermore, manufacturers are required to investigate the root causes of these quality deviations and implement corrective actions. Provincial regulatory bodies are tasked with investigating these entities for the production of substandard drugs and must publicly disclose the results of their enforcement actions.

Company: https://www.globalkeysolutions.net/companies/changchun-zhonghe-pharmaceutical-co-ltd/78d161a0-2105-49c7-a8fd-2f4babd6e1c1/