FDA 483 - Joseph C Gathe, Jr, MD, CI - March 10, 2023

An FDA inspection of Joseph C Gathe, Jr, MD, CI, a clinical investigator in Houston, revealed significant deficiencies in the conduct of a clinical study. The investigator failed to follow the study protocol, specifically regarding adverse event reporting and the documentation of subject inclusion/exclusion criteria. These issues indicate a lack of adherence to investigational plan requirements.