1063743
Amann Girrbach North America, L.P. — FEI 3005942449
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 29, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Charlotte, NC (United States)
Citations
| ID | CFR | Description |
|---|
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |