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879566

ABS Corporation — FEI 1950042

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
May 19, 2014
Fiscal Year
2014
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
110521 CFR 211.22(d)Procedures not in writing, fully followed
113421 CFR 211.25(b)Supervisor Training/Education/Experience
126121 CFR 211.68(a)Written calibration / inspection records not kept
135821 CFR 211.100(b)SOPs not followed / documented
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
439121 CFR 211.180(e)(2)Items to cover on annual reviews