FDA 483 - Novartis Pharmaceuticals Corporation - January 24, 2017

Novartis Pharmaceuticals Corp. in East Hanover, NJ, was cited for significant deficiencies in its conduct as a sponsor of clinical investigations. Observations included failures to notify the FDA of an investigator's termination, retain required records, adequately monitor study progress, and ensure studies adhered to protocols and investigational plans. These issues indicate systemic problems in clinical trial oversight.