Home / Inspections / 940586

940586

SMK Imaging LLC — FEI 3010609444

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 7, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Compliance: Devices
Location
Elmsford, NY (United States)

Facility

Other inspections at this facility

  • 1166300 (NAI Mon Mar 28 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1108788 (NAI Wed Oct 23 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1022746 (NAI Wed Aug 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 830365 (VAI Mon Apr 29 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 657556 (NAI Thu Apr 15 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
260221 CFR 820.30(d)Design output - review and approval
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ