Novartis Pharmaceuticals A. G. – FDA 483, Mar 23, 2017

An FDA inspection of Novartis Pharmaceuticals A. G. in Broomfield, CO, revealed significant deficiencies in pharmacovigilance practices. The firm failed to timely report numerous serious and unexpected adverse drug experiences to the FDA, with some reports being significantly delayed. Additionally, investigations into these late submissions were found to be inadequate, lacking proper root cause analysis and preventive actions.