Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-21.
At a glance
Inspections
3
Form 483s
3
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Nov 2025 – 21 Nov 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Sep 2022 – 9 Sep 2022 | Medical Devices & Rad Health | WL | View 483 → |
| 20 Apr 2015 – 24 Apr 2015 | Medical Devices & Rad Health | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Nov 2025
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Janet Pulver, Rebecca E Dorsey
24 Apr 2015
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by Maida Henesian, Stephen C Smith
Investigators
FDA investigators tied to this site in the record.
Janet Pulver1 insp.
Rebecca E Dorsey1 insp.
Esteban Beltran1 insp.
Maida Henesian1 insp.
Stephen C Smith1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Olympus Medical Systems Corporation'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