FDA 483 - Amerigen Pharmaceuticals Inc. - July 27, 2017

An FDA inspection of Amerigen Pharmaceuticals Inc. in Lyndhurst, NJ, revealed significant deficiencies in the firm's written procedures for handling post-marketing adverse drug experiences. The company lacked adequate procedures for the surveillance, evaluation, and reporting of adverse drug events to the FDA. This indicates a serious gap in their pharmacovigilance system.