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1091789

Philips Medical Systems (Cleveland) Inc — FEI 1525965

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 4, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Cleveland, OH (United States)

Facility

Other inspections at this facility

  • 1111084 (NAI Tue Nov 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1072883 (VAI Wed Oct 24 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1022578 (OAI Fri Aug 18 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 854978 (VAI Tue Jan 28 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 795249 (NAI Fri Aug 31 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
317321 CFR 820.198(d)Evaluation, timeliness, identification
320121 CFR 820.40(a)Not approved or obsolete document retrieval
369621 CFR 820.100(b)Documentation