FDA 483 - Ismail H. Mitha, M.D. - February 22, 2013

An FDA inspection of Lakeview Hospital - WWCT in Benoni, South Africa, revealed that a clinical investigation was not conducted in accordance with its investigational plan. Key issues included inconsistent study drug dosage calculations, failure to implement an updated informed consent document, and improper sample handling. These findings highlight significant deviations from established protocols during the study.