# China NMPA Drug Inspection - Hunan Hengwei Pharmaceutical Co., Ltd. - Refined Coronary Tablets

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/hunan-hengwei-pharmaceutical-co-ltd/4eeba4b0-9f56-4a1f-8322-e5d2aafc181d/
Source feed: China

> China NMPA drug inspection for Hunan Hengwei Pharmaceutical Co., Ltd. published August 29, 2019. Drug: Refined Coronary Tablets. The National Medical Products Administration (NMPA) of China issued Announcement No. 60 of 2019 on August 27, 2019, publ

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 60 of 2019 from the National Medical Products Administration regarding 11 batches of drugs that did not meet the requirements.
- Company Name: Hunan Hengwei Pharmaceutical Co., Ltd.
- Publication Date: 2019-08-29
- Drug Name: Refined Coronary Tablets
- Inspection Finding: Golden Orange II detected
- Action Taken: Risk control measures such as suspending sales and use and recalling products will be implemented. The reasons for non-compliance will be investigated and rectified. In accordance with the "Drug Administration Law of the People's Republic of China", cases will be filed and investigated for illegal acts of producing and selling counterfeit and substandard drugs, and the investigation and handling will be completed and the results made public within 3 months.
- Summary: The National Medical Products Administration (NMPA) of China issued Announcement No. 60 of 2019 on August 27, 2019, publicizing that 11 batches of drugs from eight different pharmaceutical companies failed to meet established quality standards. Testing conducted by several drug inspection institutions, including the China National Institutes for Food and Drug Control, revealed various critical non-compliances. Specific issues identified include content uniformity and content determination for fluoxetine hydrochloride capsules from Suzhou Yushi Pharmaceutical Co., Ltd., and visible foreign matter in compound vitamin B injection by Hainan Pharmaceutical Factory Co., Ltd. Other significant violations encompassed microbial limits for synovitis tablets from Tonghua Jinkaiwei Pharmaceutical Co., Ltd. and Liushen capsules from Lei Yunshang Pharmaceutical Group Co., Ltd. Additionally, cold soft capsules from Henan Xueyinghua Pharmaceutical Co., Ltd. failed the disintegration time limit, while Shuanghuang Xiaoyan tablets from Guangxi Ritian Pharmaceutical Group Co., Ltd. and Guangxi Nanning Dezhi Pharmaceutical Co., Ltd. exhibited weight variation issues. Notably, Hunan Hengwei Pharmaceutical Co., Ltd.'s refined coronary heart disease tablets were found to contain Orange II, indicating a potential adulteration. In response, the NMPA, operating under the "Drug Administration Law of the People's Republic of China," has mandated immediate risk control measures. These include suspending sales, discontinuing use, and initiating recalls for all affected products. The implicated companies are required to thoroughly investigate the root causes of these non-compliances and implement robust corrective actions. Furthermore, provincial drug regulatory authorities are tasked with investigating these entities for illegal drug production and sales, with results to be publicized within three months of receiving inspection reports.

Company: https://www.globalkeysolutions.net/companies/hunan-hengwei-pharmaceutical-co-ltd/c713870d-1376-494f-9b1a-c4b059c3f6ed/