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

Source: https://www.globalkeysolutions.net/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: FDA District Office — Stoneham, Massachusetts
- 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.

## Related Officers

- [Power Trader/Data Scientist](https://www.globalkeysolutions.net/people/jeffrey-j-thibodeau/62b74030-4aef-400b-8ae2-8bf84712d813)

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

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7