# Global Blood Resources, LLC – FDA 483, Jan 17, 2024

Source: https://www.keypedia.com/records/483/global-blood-resources-llc/b15cdfb3-f3c7-40c0-8568-e24bce5523d8

> FDA 483 for Global Blood Resources, LLC on January 17, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Global Blood Resources, LLC
- Inspection Date: 2024-01-17
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: 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.

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Company: https://www.keypedia.com/companies/global-blood-resources-llc/bb303375-58f0-4af8-b68d-678d2ee6586e

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94