FDA 483 - Mohammed A. Bari, MD - October 22, 2021

Mohammed A. Bari, MD, a clinical investigator in Lemon Grove, CA, was cited for significant deficiencies during an FDA inspection. The observations include failures to promptly report unanticipated problems and protocol deviations to the IRB, such as incorrect subject dosing and unconsented genetic sample collection. Additionally, the firm failed to maintain adequate and accurate case histories by not documenting adverse events.