FDA Inspection 1022352 — Denka Co. Ltd.
The FDA completed an inspection of Denka Co. Ltd. on July 6, 2017 in Gosen. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- July 6, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Gosen (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3263 | 21 CFR 820.250(b) | Sampling plans |