# China NMPA Drug Inspection - Henan Juren Traditional Chinese Medicine Pieces Co., Ltd. - Calamine

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/henan-juren-traditional-chinese-medicine-pieces-co-ltd/6cbebed1-d11d-4312-815d-846c106846b4/
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> China NMPA drug inspection for Henan Juren Traditional Chinese Medicine Pieces Co., Ltd. published December 29, 2017. Drug: Calamine. The Inner Mongolia Autonomous Region Food and Drug Administration (IMFDA) issued an announcement on December 29, 2017, d

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: (Inner Mongolia Food and Drug Administration Announcement No. 80 of 2017) Announcement of the Inner Mongolia Autonomous Region Food and Drug Administration on the Results of Drug Quality Sampling Inspection
- Company Name: Henan Juren Traditional Chinese Medicine Pieces Co., Ltd.
- Publication Date: 2017-12-29
- Drug Name: Calamine
- Inspection Finding: Content determination failed
- Action Taken: The relevant municipal and prefectural food and drug administration departments have taken timely control measures and have investigated and dealt with the production unit in accordance with the law.
- Summary: The Inner Mongolia Autonomous Region Food and Drug Administration (IMFDA) issued an announcement on December 29, 2017, detailing the results of drug quality sampling inspections. These inspections, conducted by several regional drug inspection institutes, identified seven batches of Chinese medicinal materials and processed Chinese medicinal herbs that failed to meet established quality standards, with issues traced back to the production stage. Companies involved in these quality deficiencies include Hebei Shunquanlong Pharmaceutical Co., Ltd., Jinan Renhe Chinese Medicinal Herbs Co., Ltd., Inner Mongolia Qiming Traditional Chinese Medicine Pieces Co., Ltd., Chifeng Zizhi Traditional Chinese Medicine Co., Ltd., Hebei Fujuntang Pharmaceutical Co., Ltd., Chifeng Yankang Pharmaceutical Co., Ltd., and Inner Mongolia Yishengtang Pharmaceutical Co., Ltd. The violations encompassed failures in content determination, exceeding limits for acid-insoluble ash, and non-compliance with total ash and extractive requirements. These issues were assessed against the stringent standards outlined in the Pharmacopoeia of the People's Republic of China. In response, local food and drug administration departments have implemented control measures and initiated investigations and legal actions against the responsible production units. Furthermore, the IMFDA mandated continued rigorous market oversight for traditional Chinese medicines, emphasizing enhanced sampling, stringent supervision of manufacturers to ensure adherence to quality management systems, standardized procurement, and robust control over acceptance and review processes, all aimed at safeguarding public health.

Company: https://www.globalkeysolutions.net/companies/henan-juren-traditional-chinese-medicine-pieces-co-ltd/c26ae704-9320-4d32-8356-3538ac50785b/