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808572

Infraredx, Inc. — FEI 3015551113

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 15, 2012
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Bedford, MA (United States)

Facility

Other inspections at this facility

  • 1263539 (NAI Tue Mar 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1227468 (NAI Tue Jan 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1159190 (NAI Wed Dec 08 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1013359 (NAI Fri Jun 02 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 924454 (NAI Fri Apr 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
500721 CFR 1002.13Failure to submit
73121 CFR 803.50(a)(1)Report of Death or Serious Injury