483
One Blood IncFDA 483 - One Blood Inc - December 15, 2025
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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.
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