FDA 483 - Global Blood Resources, LLC - January 17, 2024

An FDA inspection of Global Blood Resources, LLC in Windsor, CT, identified a significant issue with their process validation procedures. The firm failed to adequately review, evaluate, and revalidate a sterilization cycle after changes were implemented for their Hemobag blood bags and tubing sets. This indicates a lapse in their design control and change management processes, potentially impacting product sterility assurance.