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

An FDA inspection of Dr. Damien Sanderlin, MD, and Lone Star Clinical Research in Houston, TX, was conducted from March 27-29, 2012. This high-priority inspection, initiated by the Center for Biologics Evaluation and Research (CBER) as part of a Premarket Approval (PMA) submission for the OraQuick In-Home HIV Test, followed Compliance Program 7348.811 for clinical investigators and focused on human subject protection. The primary violation, documented on an FDA 483 (Inspectional Observations), was the failure to obtain informed consent from human subjects prior to commencing study-related procedures, specifically blood draws, which marked their enrollment. This directly contravenes regulations regarding the protection of human subjects (21 CFR 812.100) and was observed in numerous patient records where blood draws occurred minutes or even an hour before consent was documented. Management attributed this to "clock errors" but acknowledged the oversight. Additionally, several significant issues were discussed during the closeout meeting. These included untimely and improper reporting of protocol deviations to the study sponsor, discrepancies in test article accountability records suggesting delayed documentation of receipt and potential security risks, and a failure to formally document unwritten instructions from the sponsor that deviated from the approved protocol. Dr. Sanderlin committed to a written response for the informed consent observation. The FDA advised that these findings could result in further regulatory actions, including warning letters or disqualification.