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779021

Lek d.d. — FEI 3002807460

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 6, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Ljubljana (Slovenia)

Facility

Other inspections at this facility

  • 1246916 (NAI Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1254088 (NAI Mon Dec 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1178973 (VAI Fri Mar 18 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1005712 (VAI Fri Feb 24 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 935159 (VAI Tue Jun 30 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
180921 CFR 211.160(a)Following/documenting laboratory controls
203121 CFR 211.194(a)Complete test data included in records