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1151935

Enthermics Medical Systems, Inc. — FEI 1000116410

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 16, 2021
Fiscal Year
2021
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))
  • 984363 (NAI Thu Jul 21 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 935245 (NAI Fri Jun 26 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 697169 (VAI Mon Nov 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
312121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
343321 CFR 820.75(c)Process changes - review, evaluation and revalidation