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

Source: https://www.keypedia.com/records/483/oneblood-inc/e66f98eb-4c1d-4c90-9ab3-bb13ef45190e

> 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: Office of Medical Device and Radiological Health Division II
- Summary: OneBlood, Inc. in St Petersburg, FL, a blood bank, was cited for failing to submit biological product deviation reports within the required 45-day timeframe. An FDA review found 23 out of 282 reports were submitted late between December 2021 and June 2025. This issue is noted as a recurrent observation from a previous inspection.

## Related Documents

- [483 - 2025-06-06](https://www.keypedia.com/records/483/oneblood-inc/cfe8e453-52f6-4e9d-8b72-5c304711274f)

## Related Officers

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

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

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