FDA 483 - Alvogen, Inc - September 11, 2020

Alvogen, Inc. in Morristown, NJ, was cited for significant deficiencies in its adverse drug experience reporting system during an FDA inspection. The firm failed to develop written procedures for post-marketing surveillance, including social media, and submitted numerous serious and unexpected adverse drug experience reports, as well as periodic safety reports, significantly late to the FDA. These issues indicate a systemic failure in pharmacovigilance compliance.