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SFDA Penalizes Wandashan Pharmaceutical

This article was originally published in PharmAsia News

Executive Summary

China's State FDA released its latest report on the lethal Ciwujia herbal injection produced by Wandashan Pharmaceutical, concluding that the incident is a severe adverse reaction caused by bacteria. According to investigation, the particular batch of Ciwujia was soaked by rain water leading to contamination, but the company's sales person in Yunnan changed the packaging labels and sold the product. SFDA concluded that Wandashan Pharmaceutical violated the Drug Administration Law and demanded the Heilongjiang FDA to suspend the company's production and withdraw its GMP authentication. Furthermore, Wandashan Pharmaceutical will be penalized in accordance with the relevant laws. Personnel responsible for the incident will be banned from drug production and distribution for 10 years. (Click here for more - Chinese Language)

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