FDA Inspection 862058 — Abbott Point of Care Canada Limited
The FDA completed an inspection of Abbott Point of Care Canada Limited on December 5, 2013 in Nepean. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 5, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Nepean (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 3191 | 21 CFR 820.30(g) | Design validation - production units |