FDA Inspection 1202883 — The Yoshida Dental Manufacturing Co., Ltd.
The FDA completed an inspection of The Yoshida Dental Manufacturing Co., Ltd. on April 14, 2023 in Sumida. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 14, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- 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 |