Company
JapanMikasa X-Ray Co., Ltd., Bunkyo, Japan – FDA Inspections
Inspection records and compliance data for Mikasa X-Ray Co., Ltd. in Bunkyo. 2 FDA inspections on record, 2 Form 483s, last inspected June 05, 2025.
Company Profile
This profile covers Mikasa X-Ray Co., Ltd. based in Bunkyo, Japan.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected March 10, 2017. Last inspected June 5, 2025.
Most cited issue areas
- Documentation1 inspection
- Document change records, maintained.1 inspection
- Environmental control Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 5, 2025 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1272319 |
| March 10, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1008403 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Mikasa X-Ray Co., Ltd.
FEI Number
3002807605
Address
5 Chome 10-5, Koishikawa, Bunkyo, Japan
Country
Japan
ID: 89554b99-2409-4c61-80ed-03a26764d292