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1302698

Gobiquity, Inc — FEI 3010539401

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 12, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Nashville, TN (United States)

Facility

Other inspections at this facility

  • 1208567 (NAI Thu Jun 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1086534 (NAI Wed Apr 17 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1062903 (VAI Fri Aug 17 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
23019ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
23133ISO 13485:2016 Clause 7.3.9Requirements for design and development changes not met before implementation