1047590
Elos Medtech Skara AB — FEI 3012416874
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 23, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Skara (Sweden)
Citations
| ID | CFR | Description |
|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |