811214
EKOM spol. s.r.o. — FEI 3005245901
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 25, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Piestany (Slovakia)
Citations
| ID | CFR | Description |
|---|
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 2648 | 21 CFR 820.30(f) | Design verification procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 4189 | 21 CFR 820.198(a) | General |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |