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1051088

Respire Medical Holdings, LLC — FEI 3008937561

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 2, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Compliance: Devices
Location
Brooklyn, NY (United States)

Facility

Other inspections at this facility

  • 1182077 (VAI Tue Oct 25 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1100411 (VAI Thu Aug 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 996025 (NAI Tue Nov 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 862926 (NAI Thu Jan 16 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 754250 (NAI Fri Nov 18 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
310421 CFR 820.30(j)Design history file
317221 CFR 820.198(c)Investigation of device failures
319121 CFR 820.30(g)Design validation - production units
419121 CFR 806.10(a)(1)Report of risk to health
73221 CFR 803.50(a)(2)Individual Report of Malfunction