FDA 483 - Joshua M. Smith, M.D., MBA - December 08, 2022
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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.
ID · 7e3c8a90-04da-4146-97e3-4856d501f5a2