# FDA 483 - OneBlood - Crestview - April 09, 2019

Source: https://www.keypedia.com/records/483/oneblood-crestview/ec1078e9-a7ae-40ef-a241-ac35b16a1562

> FDA 483 for OneBlood - Crestview on April 09, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OneBlood - Crestview
- Inspection Date: 2019-04-09
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Oneblood, Inc. in Crestview, FL, identified two significant issues. The firm failed to perform regularly scheduled alarm checks for equipment used in blood and blood component storage and distribution over a 22-month period. Additionally, the firm failed to obtain proof of identity from a donor, citing a known acquaintance as justification, which was not supported by their SOP.

## 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-crestview/04f563d4-1df2-4a6e-a665-deb45e0e3bbe

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