# China NMPA Drug Inspection - Shaanxi Xiyue Pharmaceutical Co., Ltd. - Cystine tablets

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shaanxi-xiyue-pharmaceutical-co-ltd/a16004d6-e05f-4073-8d86-5c83b018fa28/
Source feed: China

> China NMPA drug inspection for Shaanxi Xiyue Pharmaceutical Co., Ltd. published February 17, 2017. Drug: Cystine tablets. This announcement from the State Administration for Market Regulation, published on February 17, 2017, details findings 

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 29 of 2017 from the State Administration for Market Regulation regarding 15 batches of substandard drugs.
- Company Name: Shaanxi Xiyue Pharmaceutical Co., Ltd.
- Publication Date: 2017-02-17
- Drug Name: Cystine tablets
- Inspection Finding: The appearance is substandard, and the weight variation is substandard.
- Action Taken: Seize and detain, suspend sales and use, recall products, carry out rectification, file a case for investigation and punish the relevant responsible persons.
- Summary: This announcement from the State Administration for Market Regulation, published on February 17, 2017, details findings of substandard drugs based on testing by six institutions. Eight pharmaceutical companies, including Gansu Huangfumi Pharmaceutical Co., Ltd., Chengdu Mingri Pharmaceutical Co., Ltd., and Shanxi Taiyuan Pharmaceutical Co., Ltd., were identified for producing 15 batches of non-compliant medications. Major violations concerned critical quality attributes such as bacterial count, related substances, weight variation, appearance, identification, and content determination. For example, Gansu Huangfumi’s Baotailing failed due to bacterial count, while Chengdu Mingri’s Desloratadine tablets had issues with related substances. Shanxi Taiyuan Pharmaceutical’s Compound Vitamin B tablets showed weight variation, and Zhejiang Yake Pharmaceutical’s Coenzyme Q10 capsules also failed on related substances.

Operating under the "Drug Administration Law of the People's Republic of China" (Articles 73, 74, and 75), provincial food and drug administrations have initiated control measures, including sealing and seizing affected products. The implicated companies are required to immediately suspend sales and usage, recall all substandard products, and implement corrective actions. Provincial authorities must investigate these illegal activities, issue penalty decisions within one month, report results to the State Food and Drug Administration, and make them public. Penalties will be imposed on the responsible individuals, emphasizing a commitment to drug quality and public safety.

Company: https://www.globalkeysolutions.net/companies/shaanxi-xiyue-pharmaceutical-co-ltd/2c2dfb62-b98f-4189-b05b-42c224bf136b/