FDA 483 - Karsh, Lawrence, M.D. - July 16, 2020

An FDA inspection of Lawrence I. Karsh, MD, Principal Investigator, in Denver, CO, revealed significant deficiencies in the conduct of an investigational study. The firm repeatedly enrolled ineligible subjects and randomized participants before completing all required eligibility assessments. Furthermore, the inspection found failures to promptly report adverse effects to the sponsor and to maintain adequate and accurate case histories, including issues with informed consent documentation and inconsistent recording of adverse events and concomitant medications.