709082
Accurate Set Inc — FEI 2240725
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 28, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Newark, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3149 | 21 CFR 820.180 | Availability |
| 3159 | 21 CFR 820.184 | DHR content |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |