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1018565

Siemens Healthcare Diagnostics, Inc. — FEI 1219913

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 12, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: 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))
  • 1043709 (VAI Fri Mar 02 2018 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
310821 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
316821 CFR 820.198(a)Complaints
326221 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
73221 CFR 803.50(a)(2)Individual Report of Malfunction