775226

Akers Biosciences, Inc. — FEI 1000121922

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 11, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Thorofare, NJ (United States)

Citations

IDCFRDescription
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
312021 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
366621 CFR 820.20(c)Management review - Lack of or inadequate procedures
54621 CFR 820.75(a)Lack of or inadequate process validation