1023206
MTT GMBH — FEI 3011545155
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 25, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lueneburg (Germany)
Citations
| ID | CFR | Description |
| 14717 | 21 CFR 820.30(g) | Design validation - software validation documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |