FDA Inspection 1066467 — Eizo GmbH
The FDA completed an inspection of Eizo GmbH on Sep 20, 2018 in Rulzheim. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 20, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Rulzheim (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3409 | 21 CFR 820.200(d) | Service reports |