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

An FDA inspection of Grifols Diagnostic Solutions, INC. in San Diego, CA, revealed significant deficiencies in their quality system as a Medical Device IVD Manufacturer. The firm's procedures for corrective and preventive actions, nonconformance, and product safety risk management were found to be inadequately established. This resulted in failures to properly analyze quality data, identify root causes for nonconforming products, and quantitatively define the probability of harm, as evidenced by multiple complaints regarding missing reagents.