China NMPA Drug Inspection - Hubei Yitai Pharmaceutical Co., Ltd - Silkworm slices

The Hubei Province Drug Quality Bulletin (Issue 4, 2015), published on March 11, 2016, detailed findings from drug quality supervision and sampling inspections conducted during the fourth quarter of 2015. These inspections, carried out by Hubei Province food and drug administration departments and testing institutions, covered drug production, operation, and use units throughout the province. A total of 337 batches of drugs were found non-compliant with established standards.

Key violations primarily involved Traditional Chinese Medicine (TCM) decoction pieces from numerous companies, including Hubei Yuanzhi Pharmaceutical Co., Ltd. and various other manufacturers, many noted as 'not produced by this company' or having revoked production licenses. Common issues included deviations in physical properties, incorrect identification methods (microscopic or thin-layer chromatography), and failures in quality control tests such as moisture content, ash content, impurity levels, and content determination. The regulatory framework for these assessments included the Hubei Province Drug Quality Supervision and Sampling Plan, the Chinese Pharmacopoeia 2010 Edition, and the Hubei Province Standard for Processing Traditional Chinese Medicine Slices 2009 Edition.

Required actions mandated that city and prefecture food and drug administration departments investigate and address non-compliance in accordance with relevant drug supervision laws, increase follow-up inspections, trace the sources of counterfeit drugs, and refer suspected criminal activities to public security departments for investigation.