1100385
USHIO GERMANY GmbH — FEI 3425
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 23, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Steinhoring (Germany)
Citations
| ID | CFR | Description |
|---|
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |