1226962
The Richline Group Inc — FEI 3006749547
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 12, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tamarac, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |