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791292

Ideal Implant Incorporated — FEI 3008342021

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 20, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Dallas, TX (United States)

Additional Details

Sponsor, Contract Research Organization

Facility

Other inspections at this facility

  • 1144472 (NAI Wed Jun 02 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1117250 (OAI Mon Feb 03 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 958209 (VAI Wed Feb 03 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 666800 (OAI Fri May 21 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
292821 CFR 812.40Sponsors' general responsibilities
299221 CFR 812.140(b)(2)Sponsor device shipment records inadequate
300221 CFR 812.140(b)(5)Sponsor records of adverse device effects & complaints