Home / Inspections / 626583

626583

Integra LifeSciences Corporation — FEI 1121308

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 20, 2009
Fiscal Year
2010
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Plainsboro, NJ (United States)

Facility

Other inspections at this facility

  • 1237437 (OAI Thu Aug 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1018575 (NAI Thu Jun 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 949906 (NAI Thu Dec 17 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 840748 (NAI Wed Aug 14 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 786007 (VAI Mon Jul 30 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
317321 CFR 820.198(d)Evaluation, timeliness, identification
54621 CFR 820.75(a)Lack of or inadequate process validation
73121 CFR 803.50(a)(1)Report of Death or Serious Injury
73221 CFR 803.50(a)(2)Individual Report of Malfunction
81221 CFR 803.56Submission of Supplement to Individual Report Within One Month