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881348

Catalent Argentina S.A.I.C. — FEI 3004258511

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 16, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Buenos Aires (Argentina)

Facility

Other inspections at this facility

  • 1211696 (VAI Fri Aug 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1038458 (VAI Fri Dec 22 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 803767 (NAI Fri Sep 14 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 604132 (NAI Thu Jul 02 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111121 CFR 211.25(a)Training , Education , Experience overall
121521 CFR 211.67(b)Written procedures not established/followed
241921 CFR 211.198(a)Complaint Handling Procedure
435121 CFR 211.160(b)(3)Drug products - samples representative, identified properly