FDA EIR - Duane C. Anderson M.D. - May 27, 2021

An FDA inspection of Duane C. Anderson, M.D., operating as Excel Clinical Research (ECR) in Las Vegas, NV, took place from May 19 to May 27, 2021. This was a targeted clinical investigator inspection, assessing compliance with Good Clinical Practice (GCP) requirements and applicable federal regulations, specifically under CP7348.811 Bioresearch Monitoring Clinical Investigations. The inspection evaluated Dr. Anderson’s conduct of two clinical studies, examining elements such as IRB approvals, informed consent, protocol adherence, data integrity, drug accountability, and sponsor monitoring activities. The inspection did not identify any significant issues requiring an FDA-483, Inspectional Observations. However, two minor recordkeeping observations were noted: an inconsistent task number for study drug dispensation on a Site Responsibility Log, where preparation (Task #8) was confused with dispensation (Task #9) for study coordinators, and unexplained investigational product storage temperature entries outside recorded operating hours for another study. Dr. Anderson acknowledged these findings and committed to implementing corrective actions to enhance accurate recordkeeping practices in clinical studies. The overall assessment indicated Dr. Anderson maintained adequate oversight of the reviewed clinical studies.