Overview
- 5 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
5
Form 483s
3
EIRs
0
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 → |
| 7 Nov 2022 – 10 Nov 2022 | Medical Devices & Rad Health | 483 | On file |
| 26 Jul 2012 | Not recorded | 483 | On file |
| 29 Jul 2010 | Not recorded | Clean | |
| 21 Jun 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Nov 2025
21 CFR 820.75(c)
Process changes - review, evaluation and revalidation
Cited by Stephen D Eich
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 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant's 3 Form 483s
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