# FDA 483 - OneBlood, Inc. - April 08, 2019

Source: https://www.keypedia.com/records/483/oneblood-inc/e3c725dc-64b1-4811-82a1-3e0c0be170da

> FDA 483 for OneBlood, Inc. on April 08, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OneBlood, Inc.
- Inspection Date: 2019-04-08
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: OneBlood, Inc. in Marianna, FL was inspected on April 8, 2019, and cited for a significant lapse in quality assurance. The firm failed to perform a thorough investigation and adequately document the conclusions and follow-up for an unexplained discrepancy involving a donor who experienced anemia after a donation. This indicates deficiencies in their corrective and preventive action (CAPA) processes and record-keeping.

## 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/03b82d46-0d01-4074-866d-4f5f4233f8b2

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