# China NMPA Drug Inspection - Shantou Jinshi Powder Injection Co., Ltd. - Cefuroxime sodium for injection

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shantou-jinshi-powder-injection-co-ltd/5ccc9f11-6cd5-4086-aac1-e981433c0328/
Source feed: China

> China NMPA drug inspection for Shantou Jinshi Powder Injection Co., Ltd. published January 09, 2018. Drug: Cefuroxime sodium for injection. The Xinjiang Uygur Autonomous Region Food and Drug Administration (Xinjiang FDA) issued an announcement on January 9, 20

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Drug Quality Bulletin of Xinjiang Uygur Autonomous Region
- Company Name: Shantou Jinshi Powder Injection Co., Ltd.
- Publication Date: 2018-01-09
- Drug Name: Cefuroxime sodium for injection
- Inspection Finding: Non-compliant - Solution color
- Action Taken: The Food and Drug Administration of the Autonomous Region has instructed the local food and drug regulatory authorities where the relevant enterprises are located to investigate and deal with the products that do not meet the standards and the relevant operating and using units in accordance with relevant laws and regulations.
- Summary: The Xinjiang Uygur Autonomous Region Food and Drug Administration (Xinjiang FDA) issued an announcement on January 9, 2018, detailing the outcomes of its 2017 Drug Quality Supervision and Sampling Inspection Work Plan. These inspections, conducted throughout 2017, targeted drugs across the region from various manufacturers, distributors, and user entities. The comprehensive review encompassed five primary drug categories, including chemical drugs, traditional Chinese medicine, antibiotics, biochemical drugs, and medical institution preparations. 

The second batch of inspections revealed four drug batches that failed to meet established quality standards. Notable issues included 'Non-compliant Content' for products like Heat-Clearing and Detoxifying Oral Liquid from Sichuan Taihuatang Pharmaceutical Co., Ltd., Apricot and Perilla Cough Syrup by Jilin Yizheng Pharmaceutical Group Co., Ltd., and Glucose Injection from Guizhou Tiandi Pharmaceutical Co., Ltd. Additionally, Cefuroxime Sodium for Injection, produced by Shantou Jinshi Powder Injection Co., Ltd., exhibited a 'Non-compliant Solution Color.' The regulatory framework applied for these inspections was the Chinese Pharmacopoeia, specifically the 2010 and 2015 editions. Consequently, the Xinjiang FDA has directed local regulatory departments to investigate these non-compliant products and the implicated units, ensuring appropriate legal and regulatory enforcement actions.

Company: https://www.globalkeysolutions.net/companies/shantou-jinshi-powder-injection-co-ltd/28ab4013-5fa6-4b98-8deb-3c2f18c80f79/
