636156
ABB Optical Group LLC — FEI 2916547
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 4, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Kansas City, MO (United States)
Citations
| ID | CFR | Description |
|---|
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3328 | 21 CFR 820.180(b) | Retention period |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |