China NMPA Drug Inspection - Shanghai Shangyao Xinyi Pharmaceutical Factory Co., Ltd. - Glibenclamide tablets

The State Food and Drug Administration (SFDA) of China issued a National Drug Quality Bulletin on October 29, 2012, detailing nationwide sampling inspections conducted in 2012. These inspections targeted 20 national essential drug varieties, including potassium chloride and aspirin, alongside two other pharmaceutical preparations like ganciclovir. A significant finding was that 22 batches across these 22 varieties failed to meet established quality standards.

Key violations included issues with product quality specifications during manufacturing and distribution. For example, Shandong Boshan Pharmaceutical Co., Ltd.'s Glibenclamide Tablets showed non-compliance in related substances, while Hebei Xinzhang Pharmaceutical Co., Ltd.'s Cephalosporin for Injection had clarity and color deficiencies. Hainan Sinochem United Pharmaceutical Industry Co., Ltd.'s Ganciclovir for Injection also failed solution clarity tests. During distribution, Aspirin preparations from companies like Handan Furong Pharmaceutical Co., Ltd. and Xinjiang Huakang Pharmaceutical Co., Ltd. had problems with release rates or free salicylic acid content. Thrombin Lyophilized Powder from Beijing First Biochemical Pharmaceutical Co., Ltd. and Zhuhai Special Economic Zone Biochemical Pharmaceutical Factory failed content determination tests. Traditional Chinese Medicines, such as Sishen Pill from Shanxi Kangwei Pharmaceutical Co., Ltd. and Xiangsha Liujun Pill from Gansu Tianshui Qihuang Pharmaceutical Co., Ltd., exhibited issues with identification and microbial limits.

The regulatory framework for these inspections was the national drug sampling plan, utilizing standards from the Chinese Pharmacopoeia and specific SFDA guidelines. Consequently, provincial food and drug administrations were instructed to investigate these non-compliant products and associated manufacturers, with a deadline of November 20, 2012, to submit their findings to the SFDA to ensure public drug safety.