FDA 483 - Joshua M. Smith, M.D., MBA - December 08, 2022

Joshua M. Smith, M.D., MBA, a clinical investigator in Idaho Falls, ID, was cited for two significant issues during an FDA inspection from December 6-8, 2022. The inspection revealed that the investigator failed to conduct a clinical investigation according to the protocol, specifically by incorrectly dosing subjects in a leuprolide acetate study. Additionally, the firm failed to maintain adequate and accurate case histories by not documenting concomitant medications in electronic case report forms.