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1002791

ABS Corporation — FEI 1950042

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
February 27, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Omaha, NE (United States)

Facility

Other inspections at this facility

  • 1269360 (NAI Tue Apr 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1248321 (NAI Tue Aug 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1215124 (VAI Fri Aug 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1127879 (NAI Mon Aug 03 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1082347 (NAI Thu Jan 31 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
202621 CFR 211.192Quality control unit review of records
320321 CFR 820.40(b)Document change records, maintained.
438921 CFR 211.198(a)Procedures to be written and followed
440221 CFR 211.192Written record of investigation incomplete