FDA 483 - Evan Russell, DO - October 10, 2025
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An FDA inspection of Evan Russell, DO in Kansas City, MO, revealed significant deficiencies in clinical research conduct. The firm failed to promptly report unanticipated problems to the IRB and did not conduct an investigation in accordance with the investigational plan, including enrolling ineligible subjects and neglecting data query review. Additionally, issues were found with investigational drug disposition records and the implementation of research activity changes without prior IRB approval.
ID · 63b972d7-8517-4172-8045-8c458bff8093