FDA WARNING_LETTER - Sanderlin, Damien MD - July 18, 2012

This FDA Warning Letter, dated July 27, 2012, was issued to Dr. Damien B. Sanderlin of Lone Star Clinical Research following an inspection from June 21, 2012, to July 18, 2012. The inspection, part of the Bioresearch Monitoring Program, reviewed Dr. Sanderlin's conduct of the clinical study "A Multi-Center, Actual Use Clinical Trial of the OraQuick ADVANCE™ HIV 1/2 Antibody Test Over-the Counter Product Performance in Untrained Users, Protocol OQ-OTC-5."

The primary violation identified was the failure to ensure the investigation was conducted according to the investigational plan, signed agreement, applicable FDA regulations, and IRB/FDA conditions of approval, specifically regarding the protection of subject rights, safety, and welfare [21 CFR §§ 812.100 and 812.110(b)]. The protocol required reporting newly-identified HIV positive laboratory results to the CDC in compliance with federal, state, and local regulations.

The inspection revealed that 18 study subjects in Houston, Texas, were confirmed HIV positive between December 2010 and July 2011. Despite these confirmations, there was no documentation that Dr. Sanderlin reported these HIV positive results to the Texas Department of State Health Services, as required by the Texas Administrative Code Title 25, Part 1