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938568

BURTON MEDICAL — FEI 3009542956

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 4, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Addison, IL (United States)

Facility

Other inspections at this facility

  • 1303702 (NAI Fri Feb 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1219712 (NAI Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1108943 (VAI Wed Oct 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 822959 (VAI Wed Feb 27 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
337221 CFR 820.198(d)Records of MDR Investigation
63121 CFR 803.17(a)(1)Lack of System for Event Evaluations
81221 CFR 803.56Submission of Supplement to Individual Report Within One Month