# FDA 483 - OneBlood, Inc. - January 09, 2026

Source: https://www.keypedia.com/records/483/oneblood-inc/2476101a-606d-423b-a45d-84ff946aed81

> FDA 483 for OneBlood, Inc. on January 09, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OneBlood, Inc.
- Inspection Date: 2026-01-09
- Product Type: biologics
- Office Name: FDA District Office — Atlanta, Georgia
- Summary: An FDA inspection of OneBlood, Inc. in Thomasville, GA, on January 9, 2026, revealed a significant concern regarding phlebotomy site preparation. The inspection found that phlebotomists failed to maintain the sterility of the venipuncture site by allowing non-sterile items to touch the disinfected area during whole blood collections. This practice raises concerns about the assurance of a sterile container of Whole Blood.

## Related Officers

- [Steven D. Banks](https://www.keypedia.com/people/steven-d-banks/30e4d016-e386-423d-9df8-1536cf43a0a3)

Company: https://www.keypedia.com/companies/oneblood-inc/e34b3896-b10d-4768-9ff5-5603e8e4878e

Office: https://www.keypedia.com/offices/fda-district-office-atlanta-georgia/bae3b8c4-4161-4e9f-b5d1-e0e80b6abd43