FDA 483 - Michael J. McCartney, M.D. - April 25, 2024

An FDA inspection of Michael J. McCartney, M.D. in Methuen, MA, conducted from April 1 to April 25, 2024, identified a significant deviation in clinical trial conduct. The firm failed to follow its investigational plan, specifically by enrolling and treating two study subjects who did not meet the established eligibility criteria. This indicates a procedural lapse in ensuring proper subject selection for clinical investigations.