# China NMPA Drug Inspection - Zhangye Guangtai Medicinal Materials Co., Ltd. - Black-banded snake

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/zhangye-guangtai-medicinal-materials-co-ltd/e22ebf8b-95d7-4e9c-9add-03701e0540f1/
Source feed: China

> China NMPA drug inspection for Zhangye Guangtai Medicinal Materials Co., Ltd. published January 10, 2018. Drug: Black-banded snake. The Gansu Provincial Food and Drug Administration (China NMPA) published a drug quality announcement on January 10, 2018

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Gansu Provincial Food and Drug Administration Drug Quality Announcement
- Company Name: Zhangye Guangtai Medicinal Materials Co., Ltd.
- Publication Date: 2018-01-10
- Drug Name: Black-banded snake
- Inspection Finding: Properties do not meet regulations
- Action Taken: Relevant food and drug administration departments have taken control measures such as sealing and seizing, requiring the sampled units to suspend the sale and use of the substandard products and to rectify the situation. The local municipal (prefecture-level) food and drug administration departments will investigate the illegal production and sale of substandard drugs and publicly disclose the results.
- Summary: The Gansu Provincial Food and Drug Administration (China NMPA) published a drug quality announcement on January 10, 2018, detailing supervision and sampling inspections of essential drugs and traditional Chinese medicine decoction pieces across the province. The inspections, conducted under the "Drug Administration Law of the People's Republic of China" and its implementing regulations, involved 734 batches of drugs. Out of these, 15 batches failed to meet quality standards.

Multiple manufacturers were identified with substandard products, including Aimin Pharmaceutical Group, Gansu Yalan Pharmaceutical, Lanzhou Fuxinghou Medicinal Materials, Gansu Heshunyuan Traditional Chinese Medicine Pieces, Qingyang Shenzhou Tongtai Pharmaceutical, Lanzhou Xukang Pharmaceutical, Gansu Kangle Pharmaceutical, Zhangye Guangtai Medicinal Materials, and Gansu Bencaoyuan Agricultural Technology. The primary issues varied but included failures in ethanol content, microscopic characteristics, identification, appearance, acid-insoluble ash, properties, and content determination, as measured against the Chinese Pharmacopoeia (2010 and 2015 Editions).

As a result, regulatory authorities implemented immediate control measures, such as sealing and seizing the unqualified products and mandating that sampled units suspend their sale and use while rectifying the issues. Furthermore, municipal and prefecture-level food and drug administration departments were instructed to investigate and prosecute illegal activities related to producing and selling substandard drugs, citing Articles 73, 74, and 75 of the Drug Administration Law. The handling outcomes for the responsible enterprises must be publicly disclosed within three months and reported to the Provincial Bureau.

Company: https://www.globalkeysolutions.net/companies/zhangye-guangtai-medicinal-materials-co-ltd/fec2d02f-4e68-43db-9e8c-cad559619852/