Dr. Arun Ravindran, MBBS MSc., PhDJanuary 11, 2019

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

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Record Details

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.

Company: Dr. Arun Ravindran, MBBS MSc., PhD
Inspection Date: January 11, 2019
Product Type: Drugs
Office: Center for Veterinary Medicine
Person: Alanna L. Mussawwir-Bias (Assistant Country Director, Regulatory Specialist BIMO)

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ID · 08469234-4ed9-4c30-ad74-c6300b707bc3