FDA Inspection
Mikasa X-Ray Co., Ltd.Mikasa X-Ray Co., Ltd. – FDA Inspection, Jun 5, 2025
Record Details
This FDA Inspection record concerns Mikasa X-Ray Co., Ltd., with an inspection on June 5, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · a1c48499-a97a-45c9-ad3c-693018969b1d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1272319
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40(b)Document change records, maintained.
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Other FDA inspections of Mikasa X-Ray Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 10, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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