1292692
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 19, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |