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935245

Enthermics Medical Systems, Inc. — FEI 1000116410

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
June 26, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Compliance: Devices
Location
Menomonee Falls, WI (United States)

Facility

Other inspections at this facility

  • 1276751 (VAI Thu Jul 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1151935 (VAI Thu Sep 16 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 984363 (NAI Thu Jul 21 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 697169 (VAI Mon Nov 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1472221 CFR 820.40Procedures not adequately established or maintained
315521 CFR 820.181(a)DMR device specifications
369621 CFR 820.100(b)Documentation