1202883
The Yoshida Dental Manufacturing Co., Ltd. — FEI 3002809599
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 14, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sumida (Japan)
Citations
| ID | CFR | Description |
|---|
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 14715 | 21 CFR 820.30(d) | Design output - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |