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1071863

Medstrat, Inc. — FEI 3003574171

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 9, 2018
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Downers Grove, IL (United States)

Facility

Other inspections at this facility

  • 1304426 (NAI Thu Feb 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1164141 (VAI Thu Mar 10 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 985581 (VAI Tue Sep 27 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471621 CFR 820.30(f)Design verification - output does not meet input requirement
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
317021 CFR 820.198(b)Review and evaluation for investigation