Global Blood Resources, LLCJanuary 17, 2024

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

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Record Details

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.

Company: Global Blood Resources, LLC
Inspection Date: January 17, 2024
Product Type: Device
Office: Division of Northeast Imports
Person: Jeffrey J. Thibodeau (Power Trader/Data Scientist)

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