FDA 483 - Troy Hounshell, D.O. - March 04, 2022

An FDA inspection of Troy Hounshell, D.O., a clinical investigator in West Des Moines, IA, revealed a significant failure to adhere to investigational plans and applicable FDA regulations. The firm did not conduct investigations in accordance with signed agreements and protocols, specifically by failing to report Serious Adverse Events (SAEs) to the study sponsor within the required timeframe for multiple subjects.