Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2012-04-10.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Apr 2012 | Not recorded | 483 | View 483 → |
| 20 Jul 2011 | Not recorded | 483 | View 483 → |
| 1 Sep 2010 | Not recorded | Clean | |
| 22 Sep 2009 | Not recorded | 483 | View 483 → |
| 15 Jul 2008 | Not recorded | 483 | On file |
| 16 Jul 2001 | Not recorded | Clean | |
| 24 Apr 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Apr 2012
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Julian C Hanson
20 Jul 2011
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Rebecca T Davis
22 Sep 2009
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Alexander M Kay
Investigators
FDA investigators tied to this site in the record.
Julian C Hanson1 insp.
Rebecca T Davis1 insp.
Dan G Eisenbrey1 insp.
Alexander M Kay1 insp.
Kathryn A Krentz1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 640.4(f) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind PeaceHealth Siuslaw Region's 4 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