FDA 483 - Novartis Pharmaceuticals Corporation - August 21, 2023

An FDA inspection of Novartis Pharmaceuticals Corp. in East Hanover, NJ, revealed a failure to ensure proper monitoring of a clinical study. Specifically, investigational product was not stored at the required temperature and was dispensed to subjects, with monitoring visits failing to identify these temperature excursions. This indicates a critical lapse in clinical trial oversight and product integrity.