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607750

Philips North America — FEI 3006648320

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
July 18, 2009
Fiscal Year
2009
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Cambridge, MA (United States)

Facility

Other inspections at this facility

  • 1224855 (NAI Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1005211 (VAI Fri Mar 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 777361 (VAI Fri Apr 13 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
232821 CFR 820.22Quality audits - auditor independence
316721 CFR 820.198(a)Complete files maintained
367721 CFR 820.30(g)Design validation - software validation not performed
368821 CFR 820.100(a)(1)Analysis of data/reports from data sources