FDA 483 - Damien Sanderlin, MD - March 29, 2012

An FDA inspection of Damien Sanderlin, MD in Houston, TX, revealed a significant issue with informed consent during a clinical trial for the OraQuick ADVANCE HIV 1/2 Antibody Test. The firm failed to obtain proper informed consent from human subjects prior to initiating blood draws, with multiple instances observed where consent forms were signed after samples were collected. This indicates a serious deviation from regulations regarding the protection of human subjects.