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1117250

Ideal Implant Incorporated — FEI 3008342021

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 3, 2020
Fiscal Year
2020
Product Type
Devices
Project Area
Compliance: Devices
Location
Dallas, TX (United States)

Facility

Other inspections at this facility

  • 1144472 (NAI Wed Jun 02 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 958209 (VAI Wed Feb 03 2016 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
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
311721 CFR 820.70(i)Software validation for automated processes
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
73121 CFR 803.50(a)(1)Report of Death or Serious Injury