# FDA 483 - OneBlood, Inc. - June 06, 2025

Source: https://www.keypedia.com/records/483/oneblood-inc/cfe8e453-52f6-4e9d-8b72-5c304711274f

> FDA 483 for OneBlood, Inc. on June 06, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OneBlood, Inc.
- Inspection Date: 2025-06-06
- Product Type: biologics
- Office Name: Florida District Office
- Summary: An FDA inspection of OneBlood, Inc., a blood bank in St Petersburg, FL, revealed a significant and recurrent issue with regulatory compliance. The firm failed to submit 23 out of 282 biological product deviation reports within the mandated 45-day timeframe. This indicates an ongoing problem with timely reporting of critical events.

## Related Officers

- [Laura E. Garcia](https://www.keypedia.com/people/laura-e-garcia/ad7c9bee-bbff-494f-b9cf-35c3a04316c0)
- [Annette Melendez](https://www.keypedia.com/people/annette-melendez/bc1a065d-6408-4c4b-9dcf-c6884e8a75c4)
- [Steen N. Graham](https://www.keypedia.com/people/steen-n-graham/e0ce4c37-b1f1-4d94-8071-2d89b74975fd)

Company: https://www.keypedia.com/companies/oneblood-inc/0081acec-fe29-4d57-a666-28ede5971d80

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9