FDA 483 - Maxwell B. Sauder, M.D. - April 06, 2023

The FDA inspected Maxwell B. Sauder, M.D. at the Toronto Research Centre, identifying a significant issue with the maintenance of accurate case histories. The firm failed to report adverse events and concomitant medications to the study sponsor, including some events potentially related to the investigational product and medications requiring washout periods. This indicates a failure in critical reporting procedures for clinical investigations.