FDA 483 - Dr. Arun Ravindran, MBBS MSc., PhD - January 11, 2019

The FDA inspected Dr. Arun Ravindran, a clinical investigator in Toronto, regarding a study on Esketamine for treatment-resistant depression. The inspection revealed that the investigation was not conducted in accordance with the investigational plan. Specifically, two subjects were enrolled and treated with investigational product despite meeting exclusion criteria related to prohibited concomitant therapies.