FDA 483 - Brian R. Davis, MD - May 16, 2019

An FDA inspection of Brian R. Davis, MD, a clinical investigator in El Paso, TX, revealed significant deviations from the signed statement of investigator and failures in maintaining adequate case histories for a clinical study. These issues indicate a lack of adherence to protocol and proper documentation practices, impacting the integrity of the study data. The inspection identified problems with subject enrollment, adverse event reporting, delegation of informed consent, and missing laboratory results and other critical data.