China NMPA Drug Inspection - Guizhou Shouxian Pharmaceutical Co., Ltd. - glucose injection

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.