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624829

Integra Neurosciences — FEI 3000204775

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
October 22, 2009
Fiscal Year
2010
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Anasco, PR (United States)

Additional Details

Postmarket Audit Inspections

Facility

Other inspections at this facility

  • 1203048 (NAI Fri Mar 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1100326 (VAI Fri Aug 23 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 965023 (NAI Fri Jan 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 900277 (NAI Tue Sep 30 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 857045 (OAI Tue Nov 26 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
230221 CFR 820.20(e)Quality System Procedures
369621 CFR 820.100(b)Documentation
369721 CFR 820.150(a)Stock rotation, assessment before release
53821 CFR 820.70(a)Process control procedures
73221 CFR 803.50(a)(2)Individual Report of Malfunction