FDA Inspection
Riken Keiki Co., Ltd.Riken Keiki Co., Ltd. – FDA Inspection, Jan 30, 2025
Record Details
This FDA Inspection record concerns Riken Keiki Co., Ltd., with an inspection on January 30, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 689560c1-1ffd-410c-909e-15a77e855eae
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1259495
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.25(b)Training records
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- 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 |
|---|---|---|---|
| December 9, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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