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683432

Nonin Medical, Inc — FEI 2183646

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 24, 2010
Fiscal Year
2010
Product Type
Devices
Project Area
Compliance: Devices
Location
Plymouth, MN (United States)

Facility

Other inspections at this facility

  • 1245893 (NAI Thu Jul 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 967579 (NAI Mon Feb 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 807070 (VAI Thu Nov 15 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
320121 CFR 820.40(a)Not approved or obsolete document retrieval
367721 CFR 820.30(g)Design validation - software validation not performed