China NMPA Drug Inspection - Shanxi Tongda Pharmaceutical Co., Ltd. - Tetrapanax papyriferus

This document, the "Shandong Province Drug Quality Announcement 2017, Issue 2," published by the Shandong Provincial Food and Drug Administration on April 18, 2017 (announcing findings from November-December 2016), details the results of drug quality supervision and sampling inspections. The inspections, conducted across drug production, distribution enterprises, and medical institutions, aimed to reinforce drug quality and ensure public safety. The regulatory framework guiding these inspections included the Chinese Pharmacopoeia (2010 and 2015 Editions) and the Shandong Province Traditional Chinese Medicine Pieces Processing Standards (2012 Edition). Key violations identified involved numerous manufacturers, including Anhui Bozhou Sanzhen Traditional Chinese Medicine Pieces Co., Ltd., Anhui Mengshi Traditional Chinese Medicine Pieces Co., Ltd., Bozhou Shuzhong Pharmaceutical Co., Ltd., Shandong Renhetang Pharmaceutical Co., Ltd., and Jilin Changheng Pharmaceutical Co., Ltd., among others. Main issues encompassed both "counterfeit drugs" and "drugs not meeting standards." Specific problems included deficient active ingredient content, non-compliant physical properties, impurities, incorrect ash content, heavy metal contamination, and inadequate drug dissolution. In response, municipal food and drug administrations implemented immediate control measures such as sealing, seizing, suspending sales, and recalling the substandard drugs. Furthermore, investigations and punitive actions against the responsible manufacturers and sampled units were mandated in accordance with applicable laws and regulations to address these quality deficiencies.