551537
Abbott Point of Care Canada Limited — FEI 3005643513
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 3, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Nepean (Canada)
Citations
| ID | CFR | Description |
|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3416 | 21 CFR 820.70(a)(1) | Process control instructions |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3689 | 21 CFR 820.100(a)(2) | Investigation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |