Home / Inspections / 1237772

1237772

Inspire Medical Systems Inc. — FEI 3007666314

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 10, 2024
Fiscal Year
2024
Product Type
Devices
Project Area
Compliance: Devices
Location
Golden Valley, MN (United States)

Facility

Other inspections at this facility

  • 1155387 (NAI Thu Sep 16 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1056573 (VAI Fri Jun 22 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 925638 (NAI Wed Apr 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 849620 (VAI Thu Sep 26 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
311921 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
313021 CFR 820.100(a)Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures