FDA Inspection 955935 — Riken Keiki Co., Ltd.
The FDA completed an inspection of Riken Keiki Co., Ltd. on Dec 9, 2015 in Kasukabe. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 9, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Kasukabe (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 640 | 21 CFR 803.18(a) | Event files -- failure to establish and maintain |