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FDA Inspection 1089785 — ARJ Medical, Inc. / Gulf Coast Scientific Inc

ARJ Medical, Inc. / Gulf Coast Scientific Inc — FEI 3004577174

The FDA completed an inspection of ARJ Medical, Inc. / Gulf Coast Scientific Inc on April 19, 2019 in Tampa, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 19, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Tampa, FL (United States)

Additional Details

Sponsor, Contract Research Organization

Facility

Other inspections at this facility

  • 1155973 (NAI Tue Oct 19 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1115249 (NAI Fri Jan 10 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 935240 (NAI Tue Jul 21 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 756723 (NAI Fri Dec 09 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 708908 (NAI Mon Feb 14 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources