# China NMPA Drug Inspection - Henan Hongri Kangrentang Pharmaceutical Co., Ltd. - Danshen Formula Granules

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/henan-hongri-kangrentang-pharmaceutical-co-ltd/d8a9164a-e157-4300-b557-db3a1c06d2ad/
Source feed: China

> China NMPA drug inspection for Henan Hongri Kangrentang Pharmaceutical Co., Ltd. published September 28, 2023. Drug: Danshen Formula Granules. The National Medical Products Administration (NMPA) of China, through Announcement No. 48 of 2023 on September 28, 2023,

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 48 of 2023 from the National Medical Products Administration regarding 22 batches of drugs that did not meet the requirements.
- Company Name: Henan Hongri Kangrentang Pharmaceutical Co., Ltd.
- Publication Date: 2023-09-28
- Drug Name: Danshen Formula Granules
- Inspection Finding: [Fingerprint spectroscopy], [Content determination]
- Action Taken: Drug regulatory authorities have required relevant enterprises and units to take risk control measures such as suspending sales and use, and recalling products, and to investigate the reasons for non-compliance and implement effective rectification. The National Medical Products Administration has instructed relevant provincial drug regulatory authorities to organize investigations into the suspected illegal activities of the aforementioned enterprises and units in accordance with the "Drug Administration Law of the People's Republic of China," and to publicly disclose the results of the investigations as required.
- Summary: The National Medical Products Administration (NMPA) of China, through Announcement No. 48 of 2023 on September 28, 2023, identified 22 batches of drugs from 14 manufacturers that failed to meet regulatory standards. Inspections revealed significant quality control deficiencies across various products. For instance, Shaanxi Haitian Pharmaceutical Co., Ltd.'s Xuefu Zhuyu Tablets failed identification tests. Multiple companies, including Hebei Hushi Yubo Pharmaceutical Co., Ltd. and Harbin Runhe Traditional Chinese Medicine Processing Plant, produced Fried Jujube Seeds with non-compliant moisture content, appearance, identification, and content determination. Henan Hongri Kangrentang Pharmaceutical Co., Ltd.'s Danshen Formula Granules failed fingerprint analysis and content determination. Additionally, Heilongjiang Wangda Traditional Chinese Medicine Pieces Technology Co., Ltd. had issues with total ash content in Lycium chinense root bark, while several manufacturers like Hebei Guorentang Pharmaceutical Co., Ltd. produced Ligustrum lucidum with excessive moisture. These violations fall under the regulatory framework of the "Drug Administration Law of the People's Republic of China" and the 2020 edition of the Pharmacopoeia. The NMPA requires affected companies to implement immediate risk control measures, including suspending sales, recalling substandard products, investigating the root causes of non-compliance, and undertaking thorough rectification. Provincial authorities are also mandated to investigate suspected illegal activities and publicly disclose their findings.

Company: https://www.globalkeysolutions.net/companies/henan-hongri-kangrentang-pharmaceutical-co-ltd/da7dca8e-e45f-401a-900f-3934fd770d35/