Overview
- 15 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-01-29.
At a glance
Inspections
15
Form 483s
6
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Jan 2026 – 29 Jan 2026 | Biologics | Clean | |
| 8 Aug 2022 – 9 Aug 2022 | Biologics | Clean | |
| 16 Jul 2018 – 17 Jul 2018 | Biologics | Clean | |
| 21 Jan 2016 – 28 Jan 2016 | Biologics | 483 | View 483 → |
| 6 Jan 2014 – 10 Jan 2014 | Biologics | 483 | View 483 → |
| 12 Jan 2012 | Not recorded | WL | |
| 25 Oct 2010 | Not recorded | 483 | View 483 → |
| 28 Apr 2010 | Not recorded | Clean | |
| 21 Apr 2010 | Not recorded | 483 | View 483 → |
| 2 Jul 2009 | Not recorded | 483 | View 483 → |
| 11 Sep 2008 | Not recorded | 483 | On file |
| 17 Aug 2007 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Jan 2016
21 CFR 606.100(b)(15)
Schedules and procedures for equipment & calibration
Cited by Kathryn A Krentz
28 Jan 2016
21 CFR 606.100(b)(15)
Schedules and procedures for equipment & calibration
Cited by Kathryn A Krentz
Investigators
FDA investigators tied to this site in the record.
Kathryn A Krentz5 insp.
Alexander M Kay4 insp.
Paul M Chefor1 insp.
Sunitha K Rajaram1 insp.
Julian C Hanson1 insp.
Gloria J Baca1 insp.
Donald W Jehn1 insp.
Devon M Shoop1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.60(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.180(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.80(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.100(b)(15) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.160(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.200(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.200(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Oregon Health & Science University's 6 Form 483s
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