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958209

Ideal Implant Incorporated — FEI 3008342021

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 3, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Dallas, TX (United States)

Additional Details

Postmarket Audit Inspections

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))
  • 791292 (VAI Fri Jul 20 2012 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
313021 CFR 820.100(a)Lack of or inadequate procedures
366921 CFR 820.20(c)Management review - defined interval, sufficient frequency
73221 CFR 803.50(a)(2)Individual Report of Malfunction