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FDA Inspection 1111084 — Philips Medical Systems (Cleveland) Inc

Philips Medical Systems (Cleveland) Inc — FEI 1525965

The FDA completed an inspection of Philips Medical Systems (Cleveland) Inc on November 26, 2019 in Cleveland, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 26, 2019
Fiscal Year
2020
Product Type
Devices
Project Area
Compliance: Devices
Location
Cleveland, OH (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures

Facility

Other inspections at this facility

  • 1091789 (VAI Tue Jun 04 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

FDA data resources