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FDA Inspection 1123642 — SK Biotek Ireland Ltd.

SK Biotek Ireland Ltd. — FEI 3002806583

The FDA completed an inspection of SK Biotek Ireland Ltd. on April 5, 2019 in Swords. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 5, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Swords (Ireland)

Additional Details

Mutual Recognition Agreement (MRA)

Facility

Other inspections at this facility

  • 1228150 (VAI Fri May 13 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1035255 (VAI Fri Nov 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 963209 (VAI Thu Feb 25 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 848526 (NAI Fri Sep 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 725194 (NAI Thu May 12 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources