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1182153

Philips North America LLC — FEI 1000524572

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 27, 2022
Fiscal Year
2023
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Bothell, WA (United States)

Facility

Other inspections at this facility

  • 1149323 (VAI Fri Aug 20 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1121760 (VAI Wed Mar 25 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1073302 (OAI Mon Dec 03 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 923916 (OAI Tue Apr 21 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 830352 (VAI Wed Apr 24 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
63121 CFR 803.17(a)(1)Lack of System for Event Evaluations
73221 CFR 803.50(a)(2)Individual Report of Malfunction