1298062
Encore Laboratory — FEI 3020749939
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 9, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Santa Ana, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3159 | 21 CFR 820.184 | DHR content |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |