FDA 483 - Balamurali K. Ambati , M.D., Ph.D. - April 04, 2019

An FDA inspection of Balamurali K. Ambati, M.D., Ph.D, MBA, Clinical Investigator in Eugene, OR, revealed a critical failure to submit an Investigational New Drug (IND) application. This omission occurred prior to conducting a clinical investigation involving an unapproved combination product. The study, which began in April 2017 and is ongoing, proceeded without the required FDA authorization, posing a significant regulatory non-compliance issue.