FDA 483 - Brian C. DeBeaubien, M.D. - April 24, 2026

Brian C. DeBeaubien, M.D., a clinical investigator in Saginaw, MI, was cited for failing to conduct an investigation in accordance with the investigational plan. Specifically, required cultures were not performed for 8 out of 11 subjects as mandated by Protocol Section 8.1. This indicates a significant deviation from the study protocol.