China NMPA Drug Inspection - Gansu Sanlong Ankang Pharmaceutical Co., Ltd. - Small pith

The Gansu Provincial Food and Drug Administration issued a drug quality announcement on May 4, 2018, detailing non-compliance found during targeted supervision and sampling inspections of traditional Chinese medicine decoction pieces. These inspections focused on products with historical issues of non-compliance, adulteration, counterfeiting, and those prone to dyeing, weight-increasing, or sulfur fumigation. The regulatory framework for these actions includes the "Drug Administration Law of the People's Republic of China" and its implementation regulations, alongside the "Chinese Pharmacopoeia 2015 Edition, Part I" and 2010 Edition, Second Supplement, as inspection bases. The inspections identified 29 batches of substandard traditional Chinese medicine decoction pieces from multiple manufacturers and suppliers, including Gansu Longmai Medicinal Materials Co., Ltd., Anhui Jucao Traditional Chinese Medicine Pieces Co., Ltd., and Lanzhou Antaitang Traditional Chinese Medicine Slices Co., Ltd., with batch numbers dating from 2014 to 2016. Key violations involved issues with appearance, identification, total ash content, content determination, sulfur dioxide residue, insect infestation, properties, and extractives. As a result, relevant food and drug administration departments have implemented control measures, such as sealing and seizing the affected products, and requiring sampled units to suspend their sale and use, and initiate rectification. Furthermore, municipal (prefecture-level) food and drug administration departments are mandated to investigate and prosecute these illegal activities under Articles 73, 74, and 75 of the Drug Administration Law, publicly disclose the outcomes for selling units within three months, and report findings to the Provincial Bureau.