Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-10.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Jan 2025 – 10 Jan 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 May 2017 – 5 May 2017 | Human Drugs | 483 | View 483 → |
| 2 May 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
5 May 2017
21 CFR 56.108(a)(1)
Reporting findings and actions to investigator/institution
Cited by Julian C Hanson
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 56.107(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.108(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.108(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.110(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Asante Health System IRB dba Southern Oregon IRB's 3 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat