FDA Inspection 954923 — ACUTE Innovations LLC

ACUTE Innovations LLC — FEI 3005670412

The FDA completed an inspection of ACUTE Innovations LLC on Jan 28, 2016 in Hillsboro, OR. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI)
End Date
Jan 28, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Hillsboro, OR (United States)

Citations

IDCFRDescription
311821 CFR 820.75(a)Documentation
383721 CFR 820.25(b)Training records

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