FDA 483 - Kristen M. Pettit, M.D. - April 15, 2026

An FDA inspection of Kristen M. Pettit, M.D. in Ann Arbor, MI, revealed significant deficiencies in the conduct of a clinical investigation. Observations included failures to properly investigate product complaints, incorrect subject eligibility assessments, errors in randomization, and non-adherence to subject withdrawal criteria. Additionally, inaccurate concomitant medication data led to an erroneous classification of a subject's primary efficacy endpoint.