FDA 483 - Ismail H. Mitha, M.D. - September 22, 2016

Dr. Ismail H. Mitha, a clinical investigator in Benoni, South Africa, was cited for failing to conduct an investigation in accordance with the signed statement of investigator and investigational plan. An unblinded investigator improperly evaluated subjects and their clinical responses during a study, which was contrary to the protocol's blinding requirements. This represents a significant deviation from the established clinical trial protocol.