1018320
Dr. Gernot Schuhfried Ges.m.b.H. — FEI 3005345740
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 18, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Modling (Austria)
Citations
| ID | CFR | Description |
|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 14717 | 21 CFR 820.30(g) | Design validation - software validation documentation |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |