# FDA 483 - OneBlood, Inc. - July 20, 2021

Source: https://www.keypedia.com/records/483/oneblood-inc/41cc29a9-a809-4102-a3ee-eba855ff5d61

> FDA 483 for OneBlood, Inc. on July 20, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OneBlood, Inc.
- Inspection Date: 2021-07-20
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: OneBlood, Inc. in Tallahassee, FL, a blood bank, was cited for deficiencies in equipment standardization and calibration. The inspection revealed issues with performing required quality control checks and inadequate documentation of equipment maintenance and QC events.

## Related Officers

- [Investigator at U.S.FDA](https://www.keypedia.com/people/barbara-t-carmichael/4c451805-e327-450d-b2e5-48a40f6232fe)

Company: https://www.keypedia.com/companies/oneblood-inc/67ffdc48-2219-47f0-8b1c-125f207df3f2

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