FDA 483 - Alexandra Rogers, MD - October 01, 2021

Dr. Alexandra Rogers, MD in Santa Barbara, CA, a clinical investigator, was cited for failing to conduct an investigation in accordance with the signed agreement, investigational plan, and applicable FDA regulations. Specifically, the firm did not report all adverse events relating to an enrolled subject's conditions and treatments. Additionally, Dr. Rogers failed to timely disclose a financial interest in the sponsoring company to the IRB.