Human use rabies vaccine regulatory update

Simcere said that China's State Food and Drug Administration (SFDA) found that 4 batches of the human use rabies vaccine manufactured by its Jiangsu Yanshen Biological Technology Stock Co. Ltd. subsidiary and marketed between July and October 2008 had an insufficient amount of active compound. SFDA determined that production of substandard vaccine product was a result of illegal activities, including inadequate quality control processes as well as misrepresentation and avoidance of regulatory inspection. Simcere acquired a controlling interest in Jiangsu Yanshen in October 2009. Simcere said it subsequently discovered the quality control problems that led to a voluntary suspension of operations, which led to SFDA's investigation (see BioCentury, Dec. 7, 2009). ...