China NMPA Drug Inspection - Shaanxi Xiyue Pharmaceutical Co., Ltd. - Gentiana macrophylla

The Shaanxi Provincial Food and Drug Administration issued an announcement on January 24, 2017, detailing results from its 2016 provincial drug sampling plan. This initiative aimed to enhance drug supervision and ensure public medication safety. Out of 1257 drug batches sampled across the province, 36 batches were found to be substandard, resulting in a pass rate of 97.14%. A significant concern was that 15 of these substandard batches were produced by non-labeled manufacturers, indicating potential illicit production or misrepresentation.Key violations identified primarily involved Traditional Chinese Medicine (TCM) materials and processed pieces. Issues included non-compliance with "Properties" or "Characteristics," indicating problems with authenticity, appearance, or sensory attributes. Other deficiencies related to "Identification," "Inspection" parameters such as impurities or moisture content, and "Content Determination" of active ingredients. Notable companies with products cited for non-compliance include Shaanxi Kangyu Pharmaceutical Co., Ltd., Xi'an Chinese Medicinal Pieces Factory Co., Ltd., Shaanxi Ruixin Pharmaceutical Co., Ltd., and Baoji Kexing Pharmaceutical Co., Ltd. The regulatory framework for these inspections was primarily the Chinese Pharmacopoeia (various editions, including 2010 and 2015) and relevant provincial standards.Local food and drug administration departments are mandated to investigate and handle these non-compliant entities in accordance with applicable laws and regulations to address the identified quality issues.