China NMPA Drug Inspection - Shaanxi Xiyue Pharmaceutical Co., Ltd. - Omeprazole enteric-coated tablets

The Fujian Province Drug Quality Announcement, issued on March 27, 2019, detailed the findings from the 2018 drug sampling inspections conducted across the province. These inspections, carried out by provincial and municipal food and drug regulatory departments, aimed to bolster drug quality oversight and safeguard public health. The comprehensive review encompassed drug production, distribution, and user facilities. The inspections identified 39 batches of drugs that failed to meet established quality standards. A significant portion of these non-compliant products were Traditional Chinese Medicine (TCM) pieces. Common violations included discrepancies in appearance, microstructure, moisture content, and the presence of impurities. Other issues observed involved failures in content determination, solubility, dissolution rates, related substances, and variations in tablet weight. Companies implicated in these findings included Anhui Bozhou Sanzhen Traditional Chinese Medicine Pieces Co., Ltd., Anhui Aisheng Traditional Chinese Medicine Pieces Co., Ltd., Fujian Youxi Xianjin Pharmaceutical Co., Ltd., and Guangdong Hexiang Pharmaceutical Co., Ltd., among others. These deficiencies were assessed against the stringent requirements of the 'Drug Administration Law of the People's Republic of China,' its implementing regulations, and the relevant editions of the Chinese Pharmacopoeia (primarily 2015). In response to these violations, the food and drug administration departments have initiated thorough investigations and are implementing appropriate enforcement actions against the entities responsible for the substandard drugs, ensuring accountability and adherence to regulatory mandates.