939830
AEI Technologies, Inc — FEI 3004055954
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 18, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bastrop, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14721 | 21 CFR 820.70(g)(2) | Periodic equipment inspections |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |