Sabine S. Hazan, M.D. – FDA 483, Sep 21, 2021

Sabine S. Hazan, M.D., a clinical investigator in Ventura, CA, was cited for significant deficiencies during an FDA inspection related to an investigational new drug (IND) study. Observations included failure to adhere to the investigational plan by enrolling ineligible subjects and not performing required screenings, continuing a study without active Institutional Review Board (IRB) approval, and administering investigational product and conducting study activities prior to obtaining informed consent from human subjects. These findings indicate serious non-compliance with regulations governing clinical trials and human subject protection.