FDA 483 - Ines Guttmann-Bauman MD - December 12, 2019

An FDA inspection of Ines Guttmann-Bauman, MD, a clinical investigator in Portland, OR, revealed significant deficiencies in the conduct of an investigational study. Observations included failure to follow the investigational plan, specifically regarding subject screening, laboratory result review, and proper informed consent documentation. Additionally, the firm failed to maintain adequate and accurate case histories for the investigation.