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

Source: https://www.keypedia.com/records/483/global-blood-resources-llc/de1b3548-1854-451d-87d8-7e96b079f0fb

> FDA 483 for Global Blood Resources, LLC on January 17, 2024. Product: devices. 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: devices
- Office Name: New England District Office
- Summary: An FDA inspection conducted at Global Blood Resources, LLC, from January 11 to January 17, 2024, resulted in the issuance of a Form FDA 483. This document outlines observations indicating potential deviations from regulatory requirements for medical devices. The primary observation cited a failure to review, evaluate, and revalidate a validated process when changes or deviations occurred. Specifically, the firm adopted a new sterilization cycle for its Hemobag blood bag and tubing sets on August 29, 2023, without formal sign-off or recording this change in its official records. Furthermore, the validation for this new sterilization cycle did not encompass all relevant components, and there was no documented justification to demonstrate its appropriateness for the newly incorporated parts. These issues signify a lapse in robust change control and process validation management, which are critical components of a compliant quality system for medical device manufacturers. While the FDA 483 is an observation document and not a final determination of non-compliance, Global Blood Resources, LLC acknowledged the finding and promised to implement corrective actions to address this observation. Remediation is essential for ensuring product safety and compliance with federal regulations.

## Related Documents

- [483 - 2024-01-17](https://www.keypedia.com/records/483/global-blood-resources-llc/b15cdfb3-f3c7-40c0-8568-e24bce5523d8)

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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/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144