1305742
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 5, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mount Pleasant, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23028 | ISO 13485:2016 Clause 4.1.6 | QMS software not validated prior to use or changes |