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1061747

Artivion, Inc — FEI 3001451326

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 8, 2018
Fiscal Year
2018
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Kennesaw, GA (United States)

Facility

Other inspections at this facility

  • 1237253 (NAI Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1218273 (NAI Tue Aug 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1161220 (NAI Thu Jan 20 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 917957 (NAI Mon Mar 16 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 870540 (OAI Wed Mar 19 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
311321 CFR 820.70(g)Equipment design and installation
319321 CFR 820.30(g)Design validation - simulated testing
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
323521 CFR 820.72(a)Equipment control activity documentation