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1277684

Serim Research Corporation — FEI 1833387

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
July 30, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Elkhart, IN (United States)

Facility

Other inspections at this facility

  • 1167161 (NAI Thu Apr 07 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1042762 (VAI Fri Feb 23 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 898416 (VAI Fri Sep 26 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
326321 CFR 820.250(b)Sampling plans
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
48621 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements