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657556

SMK Imaging LLC — FEI 3010609444

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
April 15, 2010
Fiscal Year
2010
Product Type
Devices
Project Area
Postmarket Assurance: 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))
  • 940586 (VAI Fri Aug 07 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 830365 (VAI Mon Apr 29 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
312021 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
366621 CFR 820.20(c)Management review - Lack of or inadequate procedures