Home / Inspections / 1043709

1043709

Siemens Healthcare Diagnostics, Inc. — FEI 1219913

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 2, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
East Walpole, MA (United States)

Facility

Other inspections at this facility

  • 1163970 (NAI Tue Mar 08 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1018565 (VAI Fri May 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 929757 (NAI Wed May 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 821920 (NAI Wed Feb 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 754929 (OAI Wed Jan 04 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
311721 CFR 820.70(i)Software validation for automated processes
312021 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
313021 CFR 820.100(a)Lack of or inadequate procedures
322621 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule