FDA Inspection 1016399 — 3SHAPE TRIOS A/S
The FDA completed an inspection of 3SHAPE TRIOS A/S on Jun 30, 2017 in Copenhagen K. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 30, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Copenhagen K (Denmark)
Citations
| ID | CFR | Description |
|---|---|---|
| 2431 | 21 CFR 820.30(b) | Design plans- updated |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |