FDA Inspection
Riken Keiki Co., Ltd.Riken Keiki Co., Ltd. – FDA Inspection, Dec 9, 2015
Record Details
This FDA Inspection record concerns Riken Keiki Co., Ltd., with an inspection on December 9, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Riken Keiki Co., Ltd.
- Inspection Date
- December 9, 2015
- Product Type
- Devices
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ID · dfafb81a-4afe-4226-97c3-08d1851968fb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 955935
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 803.18(a)Event files -- failure to establish and maintain
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Riken Keiki Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 30, 2025 | OAI | Office of Inspections and Investigations | Compliance: Medical Devices |
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