# FDA 483 - OneBlood, Inc. - March 21, 2023

Source: https://www.globalkeysolutions.net/records/483/oneblood-inc/6944237f-4547-4c35-8a27-ac43312f2d04

> FDA 483 for OneBlood, Inc. on March 21, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OneBlood, Inc.
- Inspection Date: 2023-03-21
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of OneBlood, Inc. in Pensacola, FL, identified a critical failure in equipment maintenance and quality control. The firm did not perform scheduled cleaning and maintenance on blood collection equipment as required by their SOPs, nor did management review the associated maintenance logs, indicating a significant deviation from established procedures.

## Related Officers

- [Charles D. Boison](https://www.globalkeysolutions.net/people/charles-d-boison/b128f4a3-c1b1-409f-9291-27deb111d1e5)

Company: https://www.globalkeysolutions.net/companies/oneblood-inc/4ad69618-4cb7-4db0-be9a-d6ec5d8eafb9

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64