Home / Inspections / 1210243

1210243

Elmed Incorporated — FEI 1412854

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 17, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Glendale Heights, IL (United States)

Facility

Other inspections at this facility

  • 1088027 (NAI Fri Apr 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 986692 (NAI Wed Sep 21 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 891957 (NAI Tue Aug 12 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 712807 (NAI Mon Mar 07 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 590843 (NAI Wed Jun 17 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
312021 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
316021 CFR 820.184Lack of or inadequate DHR procedures
73221 CFR 803.50(a)(2)Individual Report of Malfunction