FDA Inspection 755756 — Fukuda Denshi Co, Ltd
The FDA completed an inspection of Fukuda Denshi Co, Ltd on November 4, 2011 in Bunkyo. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 4, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bunkyo (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |