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

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.