Company
JapanShirakawa Olympus Co., Ltd., Nishishirakawa-Gun, Japan – FDA Inspections
Inspection records and compliance data for Shirakawa Olympus Co., Ltd. in Nishishirakawa-Gun. 5 FDA inspections on record, 2 Form 483s, last inspected November 14, 2025.
Company Profile
This profile covers Shirakawa Olympus Co., Ltd. based in Nishishirakawa-Gun, Japan.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected March 15, 2012. Last inspected November 14, 2025.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Investigation of device failures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 14, 2025 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1291254 |
| November 17, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1192279 |
| September 13, 2018 | Not classified | Medical Devices & Rad Health | 1068507 |
| May 21, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 928917 |
| March 15, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 776531 |
FDA documents
EIRs (1)
People (1)
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Company Information
Name
Shirakawa Olympus Co., Ltd.
FEI Number
3002808148
Address
Azaokamiyama 3-1, Oazaodakura; Nishigo-Mura, Nishishirakawa-Gun, Japan
Country
Japan
ID: e361e2d2-dfcd-4537-a76a-662476a90f1f