1276751

Enthermics Medical Systems, Inc. — FEI 1000116410

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 17, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Compliance: Devices
Location
Menomonee Falls, WI (United States)

Citations

IDCFRDescription
312321 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
316021 CFR 820.184Lack of or inadequate DHR procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures