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715165

AbbVie Ltd — FEI 3000210838

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 14, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Barceloneta, PR (United States)

Facility

Other inspections at this facility

  • 1231256 (VAI Thu Apr 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1118386 (VAI Thu Feb 20 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1081767 (NAI Fri Dec 21 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 981552 (VAI Fri Jul 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 879731 (VAI Tue May 20 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111121 CFR 211.25(a)Training , Education , Experience overall
121521 CFR 211.67(b)Written procedures not established/followed
145021 CFR 211.113(a)Procedures for non-sterile drug products
438921 CFR 211.198(a)Procedures to be written and followed