Home / Inspections / 1215339

1215339

InfuTronix LLC — FEI 3011581906

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 16, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Natick, MA (United States)

Facility

Other inspections at this facility

  • 1162460 (OAI Tue Feb 15 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1088804 (VAI Fri May 03 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1049280 (NAI Thu Apr 05 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures
366921 CFR 820.20(c)Management review - defined interval, sufficient frequency
73121 CFR 803.50(a)(1)Report of Death or Serious Injury