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1012263

Siemens Healthcare Diagnostics, Inc. — FEI 2432235

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 31, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Tarrytown, NY (United States)

Facility

Other inspections at this facility

  • 1230618 (NAI Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1167476 (NAI Wed Mar 30 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1141620 (NAI Fri Mar 12 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 896868 (NAI Fri Sep 19 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 827292 (NAI Wed Mar 13 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
323121 CFR 820.70(i)Documentation of software validation
342721 CFR 820.50(a)(2)Supplier oversight
366621 CFR 820.20(c)Management review - Lack of or inadequate procedures