1244705
Red Oak Instruments, LLC — FEI 3003786816
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 26, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Missouri City, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |