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1303608

Welmed Inc. — FEI 3005841027

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 19, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Compliance: Devices
Location
Chicago, IL (United States)

Facility

Other inspections at this facility

  • 1165199 (VAI Wed Mar 23 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1026884 (NAI Wed Aug 30 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
23088ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
23216ISO 13485:2016 Clause 8.2.2Lack of documented justification for not investigating complaint(s)