FDA 483 - Brock A. McConnehey, DO - April 02, 2021

An FDA inspection of Brock A. McConnehey, DO, a clinical investigator in Boise, ID, revealed significant deficiencies in the conduct of clinical investigations. The firm failed to adhere to study protocols and accurately report adverse events for subjects. Additionally, case histories were not accurately maintained, with numerous discrepancies in documenting concomitant medications and adverse event details in electronic case report forms.