# FDA 483 - OneBlood, Inc. - March 26, 2026

Source: https://www.keypedia.com/records/483/oneblood-inc/788c72ae-6760-4471-b170-75c803de1182

> FDA 483 for OneBlood, Inc. on March 26, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OneBlood, Inc.
- Inspection Date: 2026-03-26
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of OneBlood, Inc. in Rockledge, FL, a blood donor center, identified a significant failure to submit required Biological Product Deviation (BPD) reports. The firm permitted ineligible donors to make donations, resulting in the manufacture and distribution of Red Blood Cell units for transfusion without proper reporting. This indicates a lapse in regulatory compliance and donor eligibility screening processes.

## Related Officers

- [investigator](https://www.keypedia.com/people/mizanne-e-lewis/c79964ac-5163-44a2-89e9-8cc8775de9b4)

Company: https://www.keypedia.com/companies/oneblood-inc/f0744635-fe27-4f79-b568-ebe3368db885

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6