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FDA Inspection 1305800 — Leo Pharma A/S

Leo Pharma A/S — FEI 3002807496

The FDA completed an inspection of Leo Pharma A/S on September 26, 2024 in Ballerup. 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
September 26, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Ballerup (Denmark)

Additional Details

Mutual Recognition Agreement (MRA)

Facility

Other inspections at this facility

  • 1176888 (VAI Thu Jun 17 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 874505 (VAI Fri Mar 21 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 745558 (VAI Thu Sep 15 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 738176 (VAI Fri Jul 15 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 593741 (OAI Tue Jun 16 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources