FDA 483 - Grifols Diagnostic Solutions Inc. - October 31, 2025

An FDA inspection of Grifols Diagnostic Solutions, Inc. in Emeryville, CA, revealed a significant issue regarding clinical investigator documentation. The firm failed to obtain a complete Form FDA-1572 before allowing an investigator to participate in a study. This lapse resulted in a clinical site conducting study activities with investigational product on donor specimens without proper documentation.