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1097398

American Contract Systems — FEI 3011389083

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
July 25, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Zelienople, PA (United States)

Facility

Other inspections at this facility

  • 1167018 (VAI Fri Mar 25 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067369 (OAI Tue Oct 02 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 996158 (NAI Thu Nov 17 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 989286 (VAI Fri Oct 21 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
333121 CFR 820.181DMR - not or inadequately maintained
367721 CFR 820.30(g)Design validation - software validation not performed
54621 CFR 820.75(a)Lack of or inadequate process validation