1014903
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 15, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Maiolati Spontini (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |