FDA Inspection
Mikasa X-Ray Co., Ltd.Mikasa X-Ray Co., Ltd. – FDA Inspection, Mar 10, 2017
Record Details
This FDA Inspection record concerns Mikasa X-Ray Co., Ltd., with an inspection on March 10, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f986d49d-905c-499d-9b87-5d5d29c97118
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1008403
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Mikasa X-Ray Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 5, 2025 | VAI | Office of Inspections and Investigations | Compliance: Medical Devices |
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