FDA 483 - Sarah E. Zauber, M.D. - September 16, 2021

An FDA inspection of Sarah E. Zauber, M.D. in Indianapolis, IN, a Clinical Investigator, revealed a significant deficiency in the conduct of an investigation. The firm failed to adhere to its investigational plan by not reconsenting study subjects with updated informed consent forms, despite an IRB approval for an amendment that increased potential risks. This indicates a serious lapse in protecting study participants and following established protocols.