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1244733

Laboratorios Grifols, S.A. — FEI 3009736169

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 26, 2024
Fiscal Year
2024
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Parets Del Valles (Spain)

Facility

Other inspections at this facility

  • 1268869 (VAI Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1123400 (VAI Fri Sep 20 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1025750 (VAI Fri Sep 08 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 931864 (NAI Thu May 21 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 800408 (VAI Wed Jul 11 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
201221 CFR 211.188(b)Batch production and Batch Control Record Requirements
240121 CFR 211.194(a)(4)Complete Test Data
430321 CFR 211.67(b)Written procedures fail to include