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1109049

TriReme Medical, LLC. — FEI 3008089360

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
October 30, 2019
Fiscal Year
2020
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Pleasanton, CA (United States)

Additional Details

Sponsor, Contract Research Organization

Facility

Other inspections at this facility

  • 1172473 (VAI Fri Jun 17 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 981307 (VAI Wed Jun 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 872220 (NAI Thu Mar 06 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1452321 CFR 812.43(c)No investigator agreement
292821 CFR 812.40Sponsors' general responsibilities
299421 CFR 812.140(b)(3)Sponsor records of investigator agreements inadequate
700621 CFR 812.43(c)(5)No financial disclosure info in investigator agreement