FDA 483 - Novartis Pharmaceuticals Corporation - August 05, 2014

An FDA inspection of Novartis Pharmaceuticals Corp. in East Hanover, NJ, identified significant issues related to clinical trial oversight. The firm failed to promptly submit an IND safety report to the FDA and did not inform participating investigators in a timely manner regarding a suspected adverse reaction. Additionally, the inspection revealed a failure to ensure proper monitoring of the study, including missing monitoring visit reports and infrequent monitoring visits.