Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-14.
At a glance
Inspections
5
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Nov 2025 – 14 Nov 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Nov 2022 – 17 Nov 2022 | Medical Devices & Rad Health | 483 | On file |
| 10 Sep 2018 – 13 Sep 2018 | Medical Devices & Rad Health | 483 | On file |
| 18 May 2015 – 21 May 2015 | Medical Devices & Rad Health | Clean | |
| 15 Mar 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Nov 2025
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Stephen D Eich, Janet Pulver, Rebecca E Dorsey
14 Nov 2025
21 CFR 820.198(c)
Investigation of device failures
Cited by Stephen D Eich, Janet Pulver, Rebecca E Dorsey
14 Nov 2025
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Stephen D Eich, Janet Pulver, Rebecca E Dorsey
14 Nov 2025
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Stephen D Eich, Janet Pulver, Rebecca E Dorsey
14 Nov 2025
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Stephen D Eich, Janet Pulver, Rebecca E Dorsey
Investigators
FDA investigators tied to this site in the record.
Stephen D Eich3 insp.
Janet Pulver1 insp.
Rebecca E Dorsey1 insp.
Amy M Cramer1 insp.
Frank J Marciniak1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Shirakawa Olympus Co., Ltd.'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