Home / Inspections / 721635

721635

Akers Biosciences, Inc. — FEI 1000121922

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
May 9, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Thorofare, NJ (United States)

Facility

Other inspections at this facility

  • 947128 (NAI Wed Nov 04 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 775226 (VAI Wed Apr 11 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 571594 (NAI Thu Apr 09 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
323121 CFR 820.70(i)Documentation of software validation
328621 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate