1287168
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 8, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fishers, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |