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762172

Siemens Healthcare Diagnostics, Inc. — FEI 2432235

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 29, 2011
Fiscal Year
2012
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))
  • 1012263 (VAI Wed May 31 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 896868 (NAI Fri Sep 19 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471621 CFR 820.30(f)Design verification - output does not meet input requirement
243021 CFR 820.30(b)Design plans - Lack of or inadequate
260421 CFR 820.30(e)Design review - Lack of or inadequate procedures
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
317021 CFR 820.198(b)Review and evaluation for investigation
367221 CFR 820.30(c)Design input - review and approval
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate