1283758
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 25, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Elmhurst, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |