FDA 483 - Novartis Pharmaceuticals Corporation - July 02, 2019

During an inspection from June 19 to July 2, 2019, Novartis Pharmaceuticals Corporation in East Hanover, NJ, was cited for failing to ensure a clinical study was conducted in accordance with its protocol and standard operating procedures. The firm did not provide necessary documentation to demonstrate that user acceptance testing for an Interactive Response Technology (IRT) system, critical for trial activities, was properly approved and signed. This indicates a significant deficiency in record-keeping and adherence to trial conduct requirements.