FDA 483 - Lifebridge Health, Inc. IRB - March 11, 2026

An FDA inspection of Lifebridge Health, Inc. IRB in Baltimore, MD, revealed a significant deficiency in their review process. The Institutional Review Board failed to document required determinations for studies involving children, specifically regarding compliance with 21 CFR 50 Subpart D. This indicates a lapse in ensuring additional safeguards for vulnerable populations in clinical investigations.