FDA 483 - Biogen, Inc. - April 06, 2017

Biogen Inc. in Cambridge, MA, a pharmaceutical manufacturer, was cited for significant deficiencies in its pharmacovigilance reporting during an FDA inspection. The firm failed to submit numerous serious and unexpected adverse drug experience reports, including cases with an outcome of death, within the required 15-day timeframe due to a database error. Additionally, annual periodic adverse drug experience reports were not submitted within the mandated 60 days of their anniversary dates.