FDA 483 - Grifols Diagnostic Solutions Inc. - August 26, 2025

An FDA inspection of Grifols Diagnostic Solutions, INC. in San Diego, CA, a medical device IVD manufacturer, revealed significant deficiencies in their corrective and preventive action (CAPA) procedures. The firm failed to adequately establish procedures for analyzing quality data, identifying root causes of nonconformities, and quantitatively defining the probability of harm in risk assessments. These systemic issues led to multiple complaints regarding missing or empty enzyme reagents, indicating a breakdown in quality control and risk management.