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GC AMERICA INC. — FDA Facility Profile

FEI 1410097

GC AMERICA INC. is an FDA-registered facility (FEI 1410097) located in ALSIP, IL, US. RegDataLab tracks 7 FDA inspections and 2 compliance actions at this facility.

Facility Details

Location
ALSIP, IL (US)
Registration Expires
N/A
Operations
Source
device

Recent inspections

  • 1084965 (VAI Thu Mar 28 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1043274 (NAI Mon Feb 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 945475 (OAI Mon Oct 26 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 891012 (NAI Fri Jun 06 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 836382 (VAI Thu Jun 13 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 792371 (OAI Fri Jul 13 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 653155 (NAI Mon Feb 08 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • 823-0224686-1/100001/1 (Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-4872259-4/10001/1 (Wed Oct 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 823-0203250-1/151/1 (Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • D03-0210187-4/21/1 (Wed Dec 08 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • UPS-3920942-2/1/1 (Tue Mar 10 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • UPS-3920942-2/1/2 (Tue Mar 10 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • UPS-3920942-2/1/3 (Tue Mar 10 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources