FDA 483 - Grifols Diagnostic Solutions Inc. - February 17, 2022

An FDA inspection of Grifols Diagnostic Solutions Inc. in San Diego, CA, a licensed device/IVD establishment, revealed two significant observations. The firm failed to promptly review, evaluate, and investigate complaints for MDR-reportable events, with technical support staff providing insufficient detail for safety assessments. Additionally, procedures for design changes were found to be inadequately established, specifically concerning the risk assessment for extended onboard stability of licensed test kits and analyzer software.