China NMPA Drug Inspection - Tiandi Hengyi Pharmaceutical Co., Ltd. - Tortoise shell (processed)

A provincial drug quality bulletin from Hubei Province, issued on June 27, 2014, detailed the findings of supervision and sampling inspections conducted in the first quarter of 2014. These inspections, carried out by the Hubei Provincial Institute for Food and Drug Control and local testing institutions, covered numerous pharmaceutical manufacturers, distributors, and medical institutions across the province under the provincial drug quality supervision plan.

Out of 637 batches of 431 drug varieties sampled, 42 batches across 25 varieties failed to meet quality standards. Significant issues were identified during routine supervision, where 38 batches failed, primarily from pharmaceutical distributors (26 batches) and manufacturers (8 batches). A notable finding was the high failure rate among traditional Chinese medicinal materials (27 batches from 98 sampled), alongside failures in traditional Chinese medicine preparations and a chemical drug. Violations included deficiencies in "Properties," "Identification," "Content Determination," and "Weight Variation," as assessed against standards such as the Chinese Pharmacopoeia 2010 Edition and various National Drug Standards. Critically, several instances of "not produced, counterfeit" products were identified, involving entities like Anhui Bozhou Shuanghua Traditional Chinese Medicine Slices Factory and Guizhou Dacheng Pharmaceutical Co., Ltd.

As a result, municipal and prefectural food and drug administration departments are mandated to investigate and address these non-compliant drugs and the associated entities.