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708678

Innovative Medical Equipment — FEI 3007353136

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
February 15, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Beachwood, OH (United States)

Facility

Other inspections at this facility

  • 1164125 (VAI Thu Mar 10 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1059092 (VAI Tue Jul 17 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 663430 (VAI Tue May 18 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1472021 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
337521 CFR 820.198(e)Records of complaint investigation
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
369621 CFR 820.100(b)Documentation