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1049773

Takeda Ireland Ltd — FEI 3002870748

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 27, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Kilruddery (Ireland)

Facility

Other inspections at this facility

  • 1255720 (VAI Fri Dec 09 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1128233 (VAI Fri Feb 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 963936 (NAI Wed Mar 02 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 812536 (NAI Thu Dec 20 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 585923 (VAI Thu Apr 30 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
360321 CFR 211.160(b)Scientifically sound laboratory controls
440621 CFR 211.194(a)(2)Suitability of testing methods verified