FDA 483 - Lauren R. Klein, M.D. - April 23, 2019

Lauren R. Klein, MD, MS, Sponsor-Investigator in Minneapolis, MN, was cited for significant deficiencies in conducting clinical investigations. The inspection revealed failures to submit Investigational New Drug (IND) applications, obtain informed consent, and ensure proper Institutional Review Board (IRB) oversight for study changes and adverse event reporting. Additionally, the firm failed to adhere to investigational plans, maintain adequate case histories, monitor studies, and keep proper investigational drug disposition records.