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1303546

EUSA Global, LLC — FEI 3007532396

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
February 6, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Medley, FL (United States)

Facility

Other inspections at this facility

  • 1233725 (NAI Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1155026 (VAI Fri Oct 15 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1069914 (VAI Wed Oct 17 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 906893 (VAI Tue Dec 09 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
23033ISO 13485:2016 Clause 4.2.1QMS documentation does not include required documents
23087ISO 13485:2016 Clause 7.1Product realization risk management processes not documented