FDA 483 - Neelakantan Anand, MD - October 24, 2019

An FDA inspection of Neelakantan Anand, MD, a clinical investigator in Los Angeles, revealed a significant issue with the reporting of serious adverse events (SAEs). The firm failed to conduct investigations in accordance with its investigational plan, specifically lacking a formal process to document the date and time of awareness for SAEs. This deficiency impacts the timely reporting of critical safety information during an ongoing investigational trial.