FDA Inspection 942394 — Cancer Diagnostics Inc.

Cancer Diagnostics Inc. — FEI 3007496191

The FDA completed an inspection of Cancer Diagnostics Inc. on Sep 11, 2015 in Durham, NC. 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
Sep 11, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Compliance: Devices
Location
Durham, NC (United States)

Citations

IDCFRDescription
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures
312721 CFR 820.80(e)Documentation

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