FDA Inspection 862058 — Abbott Point Of Care Canada Limited

Abbott Point Of Care Canada Limited — FEI 3005643513

The FDA completed an inspection of Abbott Point Of Care Canada Limited on Dec 5, 2013 in Nepean. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Dec 5, 2013
Fiscal Year
2014
Product Type
Devices
Project Area
Compliance: Devices
Location
Nepean (Canada)

Citations

IDCFRDescription
319121 CFR 820.30(g)Design validation - production units

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.