# China NMPA Drug Inspection - Shanghai Ziyuan Pharmaceutical Co., Ltd. - Niuhuang Jiedu Tablets

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shanghai-ziyuan-pharmaceutical-co-ltd/9a47c123-6241-44f8-b8ce-1e9e15d0fa59/
Source feed: China

> China NMPA drug inspection for Shanghai Ziyuan Pharmaceutical Co., Ltd. published September 18, 2018. Drug: Niuhuang Jiedu Tablets. The Shanghai Municipal Food and Drug Administration (SMFDA) published its 2018 Issue No. 8 Drug Supervision and Sampling

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Shanghai Municipal Food and Drug Administration's 8th Announcement on Drug Supervision and Sampling Quality in 2018 (September 18, 2018)
- Company Name: Shanghai Ziyuan Pharmaceutical Co., Ltd.
- Publication Date: 2018-09-18
- Drug Name: Niuhuang Jiedu Tablets
- Inspection Finding: Content determination
- Action Taken: The Shanghai Municipal Food and Drug Administration has organized relevant regulatory departments to investigate and deal with the matter in accordance with the law and take control measures, requiring relevant entities to immediately suspend sales and use, recall products, and make rectifications.
- Summary: The Shanghai Municipal Food and Drug Administration (SMFDA) published its 2018 Issue No. 8 Drug Supervision and Sampling Quality Announcement on September 18, 2018, detailing findings from recent quality supervision and sampling inspections. These inspections targeted various drug and pharmaceutical packaging material units within the city. Key findings revealed multiple instances of non-compliance across both market circulation/use and production stages.

Notable violations included issues with "Whole Scorpion Processed Slices" from Hebei Quantai Pharmaceutical Co., Ltd., failing inspections for appearance and moisture content. Shanghai Lei Yunshang Pharmaceutical Co., Ltd.'s "Niuhuang Jiedu Tablets" were found non-compliant in content determination. Other products, such as "Fried Cassia Seeds" (Shanghai Kangqiao Traditional Chinese Medicine Slices Co., Ltd.), "Compound Honeysuckle Granules" (Harbin Huayu Pharmaceutical Group Co., Ltd.), and "Alum" (Suzhou Chunhuitang Pharmaceutical Co., Ltd.), exhibited deficiencies in content determination, fill weight difference, and identification, respectively.

The regulatory framework for these assessments primarily involved the 2015 Edition of the Chinese Pharmacopoeia and relevant supplementary standards from the State Drug Administration. The SMFDA has mandated immediate suspension of sales and use for non-compliant products, product recalls, and comprehensive rectification. Affected companies are required to investigate root causes, implement corrective measures, and eliminate potential risks, supported by strengthened daily supervision and follow-up inspections by regulatory bodies.

Company: https://www.globalkeysolutions.net/companies/shanghai-ziyuan-pharmaceutical-co-ltd/d43e4356-b577-4912-8ef3-5772975f7de7/