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933338

Allergan Pharmaceuticals Ireland — FEI 3002806285

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 3, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Westport (Ireland)

Facility

Other inspections at this facility

  • 1194596 (VAI Fri Jun 17 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1117366 (VAI Fri May 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1002463 (NAI Fri Dec 16 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 842267 (NAI Thu Jul 11 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 737741 (NAI Tue May 17 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
193321 CFR 211.167(a)Sterility/pyrogens - test methods written, followed
360321 CFR 211.160(b)Scientifically sound laboratory controls
361321 CFR 211.160(b)(4)Establishment of calibration procedures
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications