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

An FDA directed follow-up inspection of Dr. Damien Sanderlin, MD, operating Lone Star Clinical Research in Houston, TX, occurred from June 21 to July 18, 2012. This inspection, guided by Compliance Program 7348.811 and addressing prior deficiencies from a March 2012 review, focused on the OraQuick In-Home HIV Test study (Protocol OQ-OTC-5). The site had enrolled 500 subjects. The inspection identified multiple violations, resulting in a two-item FDA 483 (Inspectional Observations). Key issues included the Investigator's failure to adequately supervise the investigational device use. Research coordinators were found to have backdated HIV-positive subject referral forms and managed high volumes of subjects (up to 81 daily) with minimal staff, undermining protocol-mandated one-on-one interactions. Dr. Sanderlin also electronically signed off on numerous case report forms with insufficient review time, indicating a lack of concurrent oversight for data accuracy. Furthermore, the protection of subject rights, safety, and welfare was deemed inadequate. There was no verification that HIV-positive subjects received CDC-compliant post-test counseling or that their results were properly reported to federal, state, and local health authorities, with staff mistakenly believing telephone calls to the CDC sufficed. Consent procedures for minor participants were also flawed; legal guardian status was often unverified, and their presence at crucial study visits was not consistently documented. An FDA 483 was issued to Dr. Sanderlin, who committed to providing a written response. No voluntary corrective actions had been implemented since the previous inspection.