921735
EPflex Feinwerktechnik GmbH — FEI 3003289691
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 26, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dettingen An Der Erms (Germany)
Citations
| ID | CFR | Description |
|---|
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |