# FDA 483 - American Red Cross Blood Svcs - October 16, 2023

Source: https://www.keypedia.com/records/483/american-red-cross-blood-svcs/2a8f1d5e-d851-4821-abd1-a1c32a5c7d32

> FDA 483 for American Red Cross Blood Svcs on October 16, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Red Cross Blood Svcs
- Inspection Date: 2023-10-16
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: An FDA inspection of American Red Cross Blood Svcs in Durham, NC, identified a significant issue regarding data integrity. The firm failed to ensure backup data was exact, complete, and secure, specifically noting an unvalidated blood establishment computer system used in their immunology reference laboratory. This raises concerns about the reliability of patient testing data.

## Related Officers

- [Steven D. Banks](https://www.keypedia.com/people/steven-d-banks/30e4d016-e386-423d-9df8-1536cf43a0a3)
- [Marla A. Cassidy](https://www.keypedia.com/people/marla-a-cassidy/d2859ca5-e77b-4385-9a96-4c785f3ac4c6)

Company: https://www.keypedia.com/companies/american-red-cross-blood-svcs/dbc004ef-d184-4e65-8bcd-71f7c1f9cd64

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7