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1182077

Respire Medical Holdings, LLC — FEI 3008937561

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 25, 2022
Fiscal Year
2023
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Brooklyn, NY (United States)

Facility

Other inspections at this facility

  • 1100411 (VAI Thu Aug 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1051088 (VAI Wed May 02 2018 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
1471621 CFR 820.30(f)Design verification - output does not meet input requirement
1472221 CFR 820.40Procedures not adequately established or maintained
333121 CFR 820.181DMR - not or inadequately maintained
342521 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
383721 CFR 820.25(b)Training records
73121 CFR 803.50(a)(1)Report of Death or Serious Injury