1291064
Banyan USA LLC — FEI 3020737798
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 12, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hauppauge, NY (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 |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |