Overview
- 9 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-30.
At a glance
Inspections
9
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Jun 2026 – 30 Jun 2026 | Biologics | 483 | View 483 → |
| 19 Oct 2022 – 20 Oct 2022 | Biologics | Clean | |
| 11 Sep 2017 – 13 Sep 2017 | Biologics | Clean | |
| 21 Jul 2016 – 22 Jul 2016 | Biologics | 483 | On file |
| 11 Dec 2014 – 16 Dec 2014 | Biologics | 483 | View 483 → |
| 22 Oct 2013 – 29 Oct 2013 | Biologics | 483 | View 483 → |
| 25 Feb 2013 – 1 Mar 2013 | Biologics | 483 | View 483 → |
| 5 Aug 2009 | Not recorded | 483 | View 483 → |
| 5 Jun 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Peter S Kessler3 insp.
Sunitha K Rajaram2 insp.
Julian C Hanson2 insp.
Kaarin M Slotte1 insp.
Kathryn A Krentz1 insp.
Rebecca T Davis1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.47(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.80(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.80(d)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.150(c)(1)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.60(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.60(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.85(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.90(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Olympia Women's Health's 7 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