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1063862

Gentherm Medical, LLC — FEI 1516825

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
August 30, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Blue Ash, OH (United States)

Facility

Other inspections at this facility

  • 1133261 (NAI Fri Oct 09 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1003116 (NAI Wed Jan 18 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 820605 (NAI Fri Mar 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 753901 (VAI Fri Nov 18 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 634697 (OAI Mon Dec 14 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures