FDA 483 - Organ Procurement Agency of Michigan - June 18, 2025

An FDA inspection of Organ Procurement Agency of Michigan in Ann Arbor, MI, a tissue recovery establishment, revealed a significant issue with the effectiveness and reporting of corrective actions. The firm failed to ensure that corrective actions were adequate and effective, specifically regarding contamination rates of recovered dermis and musculoskeletal tissue. Despite exceeding action levels multiple times, required incident reports were not submitted to Quality, indicating a breakdown in their quality system.