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1217802

SunMed Holdings, LLC — FEI 1314417

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 30, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
Location
Grand Rapids, MI (United States)

Facility

Other inspections at this facility

  • 1062683 (NAI Wed Jul 11 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 977549 (VAI Fri Jun 24 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 961621 (VAI Wed Mar 02 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 938637 (NAI Tue Aug 04 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 915514 (OAI Mon Mar 02 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate