Actavis Elizabeth LLC, A Company of Teva – FDA 483, Apr 26, 2011

The FDA inspection of Actavis Elizabeth LLC in Elizabeth, NJ, revealed significant deficiencies in their adverse drug experience reporting system. The firm failed to promptly review adverse event information and submit serious and unexpected adverse drug experience reports to the FDA within the required 15-day timeframe. Additionally, critical written procedures for post-marketing surveillance, evaluation, and training related to adverse drug experiences were not established.