FDA Inspection 551537 — Abbott Point Of Care Canada Limited
The FDA completed an inspection of Abbott Point Of Care Canada Limited on Nov 3, 2008 in Nepean. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Nov 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 |