FDA 483 - Novartis Pharmaceuticals Corporation - December 14, 2018

Novartis Pharmaceuticals Corp. in East Hanover, NJ, was cited for significant failures in monitoring a clinical study. The firm failed to ensure the study was conducted according to the protocol and investigational plan, leading to numerous instances of site personnel and raters having inappropriate access to unblinded study subject information. Monitors also failed to identify and correct these critical database access errors over an extended period.