FDA 483 - MRIGlobal - August 29, 2022

MRIGlobal, a contract laboratory in Kansas City, MO, was cited for significant deficiencies in its quality system related to investigations. The firm failed to consistently document conclusions, identify root causes, or implement follow-up corrective actions for unexplained discrepancies, resulting in a backlog of open quality reports and CAPAs. This indicates a systemic issue with their investigation and corrective action processes.