FDA Inspection 590133 — Fukuda Denshi Co., Ltd.
The FDA completed an inspection of Fukuda Denshi Co., Ltd. on June 4, 2009 in Bunkyo. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 4, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Bunkyo (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3696 | 21 CFR 820.100(b) | Documentation |