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1223732

Instituto Grifols, S.A. — FEI 3002807257

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 17, 2023
Fiscal Year
2024
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Parets Del Valles (Spain)

Facility

Other inspections at this facility

  • 1097198 (VAI Tue Jun 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 950687 (VAI Wed Sep 16 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 845529 (VAI Thu Jul 18 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 723498 (VAI Tue Mar 22 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 583241 (VAI Thu May 07 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
191221 CFR 211.166(a)Written program not followed
202721 CFR 211.192Investigations of discrepancies, failures
241921 CFR 211.198(a)Complaint Handling Procedure
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified