FDA 483 - Teirstein, Paul S. MD - August 17, 2015

Paul S. Teirstein, MD, a clinical investigator in La Jolla, CA, was cited for significant deviations from investigational plans and informed consent requirements. The inspection revealed that subjects were enrolled despite not meeting inclusion/exclusion criteria and serious adverse events were not reported in a timely manner. Additionally, informed consent documents were not provided in a language understandable to non-English speaking subjects.