# FDA 483 - One Blood Inc - December 15, 2025

Source: https://www.keypedia.com/records/483/one-blood-inc/e72dad7e-01ec-4973-8801-9b08f1979582

> FDA 483 for One Blood Inc on December 15, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: One Blood Inc
- Inspection Date: 2025-12-15
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: One Blood Inc, a blood donor center in Concord, NC, was inspected by the FDA, revealing a significant issue with their computer systems. The inspection found that the firm failed to maintain appropriate validation data for its blood establishment computer software, which has been in use since 2019 without proper validation at this location. This indicates a lapse in ensuring the reliability of automated processes.

## Related Officers

- [Marla A. Cassidy](https://www.keypedia.com/people/marla-a-cassidy/d2859ca5-e77b-4385-9a96-4c785f3ac4c6)

Company: https://www.keypedia.com/companies/one-blood-inc/1c591bd2-2836-4be9-ba67-6a9a633aed94

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