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1173210

Kedrion S.p.A. — FEI 3008919567

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 24, 2022
Fiscal Year
2022
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Gallicano (Italy)

Facility

Other inspections at this facility

  • 990289 (VAI Fri Sep 16 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 907163 (VAI Fri Jun 27 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 785499 (VAI Wed Apr 18 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
136121 CFR 211.100(a)Absence of Written Procedures