FDA Inspection 1270944 — Labena d.o.o.

Labena d.o.o. — FEI 3003736847

The FDA completed an inspection of Labena d.o.o. on April 25, 2024 in Ljubljana. 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 25, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Ljubljana (Slovenia)

Additional Details

Mutual Recognition Agreement (MRA)