# FDA 483 - Asante Health System IRB dba Southern Oregon IRB - January 10, 2025

Source: https://www.globalkeysolutions.net/records/483/asante-health-system-irb-dba-southern-oregon-irb/ea65a53d-093e-41d1-a5cb-fa0c089d9715

> FDA 483 for Asante Health System IRB dba Southern Oregon IRB on January 10, 2025. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Asante Health System IRB dba Southern Oregon IRB
- Inspection Date: 2025-01-10
- Product Type: other
- Office Name: Seattle District Office
- Summary: An FDA inspection of Asante Health System IRB dba Southern Oregon IRB in Medford, OR, revealed a significant procedural lapse. The Institutional Review Board failed to adhere to its own expedited review procedures, specifically by not notifying members of studies and related documents approved via expedited review in 2023. This indicates a breakdown in internal controls for research oversight.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sherri-n-rohlf/41090ab1-83d1-4e95-92ea-0cfca5cecdb6)

Company: https://www.globalkeysolutions.net/companies/asante-health-system-irb-dba-southern-oregon-irb/f41ff4f4-dfa0-48e9-bc1a-e0cd408e5c4d

Office: https://www.globalkeysolutions.net/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913