1280564
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 4, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3668 | 21 CFR 820.20(c) | Management review dates |