FDA 483 - Savita Rangarajan, MD, MBBS, FRCPath - September 27, 2024

An FDA inspection of KJ Somaiya Hospital and Research Centre in Mumbai, India, revealed significant issues with maintaining accurate case histories for investigational drug studies. The site failed to reconcile the timing of investigational product administration with the vendor-supplied interactive response technology (IRT) system. These discrepancies, observed across three reviewed studies, indicate potential data integrity concerns in clinical trial documentation.