752065

ACUTE Innovations LLC — FEI 3005670412

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 21, 2011
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Hillsboro, OR (United States)

Citations

IDCFRDescription
1471921 CFR 820.30(h)Incorrect translation to production specifications
243021 CFR 820.30(b)Design plans - Lack of or inadequate
313021 CFR 820.100(a)Lack of or inadequate procedures
316821 CFR 820.198(a)Complaints