FDA 483 - Shahrukh A. Kureishy, MD - May 09, 2022

An FDA inspection of Shahrukh A. Kureishy, MD, a clinical investigator in McKinney, TX, revealed a significant deviation from an investigational plan. A study subject who met withdrawal criteria due to hospitalization was not withdrawn and continued to receive the test article. This indicates a failure to adhere to study protocol and proper subject management.