China NMPA Drug Inspection - Life Science (Zhongshan) Biopharmaceutical Co., Ltd. - Omeprazole enteric-coated capsules

The State Food and Drug Administration (SFDA) of China issued a National Drug Quality Bulletin on January 18, 2013, detailing findings from national drug sampling inspections conducted throughout 2012. The regulatory review targeted 17 essential drug varieties and 3 other pharmaceutical preparations, totaling 20 different drug types. Inspections revealed critical quality control deficiencies, with 37 batches of products failing to meet established standards across numerous pharmaceutical manufacturers. Primary violations included non-compliance with microbial limits, inaccuracies in active ingredient content assay (e.g., for Chenpi, Panax notoginseng, Morphine), and improper drug release rates for enteric-coated formulations such as Diclofenac Sodium and Omeprazole. Issues with incorrect quantities or dosages in injections (e.g., Glucose, Sodium Chloride), as well as ethanol content and activity assays, were also identified. These non-conformities were evaluated against the Chinese Pharmacopoeia, Ministry of Health Drug Standards, and National Drug Standards. The SFDA mandated that provincial food and drug administration departments investigate the implicated drugs and manufacturers, requiring submission of their findings by February 20, 2013, to ensure appropriate corrective actions and public drug safety.