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1057633

Integra LifeSciences Corporation — FEI 3004608878

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 2, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Cincinnati, OH (United States)

Facility

Other inspections at this facility

  • 1274595 (NAI Fri Jun 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 973206 (NAI Mon May 02 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 863101 (NAI Thu Jan 16 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 715419 (NAI Tue Mar 22 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
50221 CFR 820.60Identification procedures, Lack of or inadequate procedures