FDA 483 - Alcon Research LLC - May 16, 2016

Alcon Research Limited in Fort Worth, Texas, was inspected by the FDA from May 16-23, 2016. The inspection revealed a significant issue with the timely submission of periodic adverse drug experience reports for multiple ophthalmic and otic drug products. Reports for Azelastine Ophthalmic Solution were submitted years late, and one for Xtoro Otic Suspension was submitted one day late.