FDA Inspection 1019209 — 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 May 12, 2017 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). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
May 12, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Nepean (Canada)

Citations

IDCFRDescription
337521 CFR 820.198(e)Records of complaint investigation
63021 CFR 803.17Lack of Written MDR Procedures

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