FDA Inspection 1155320 — Novartis d.o.o.

Novartis d.o.o. — FEI 3002807470

The FDA completed an inspection of Novartis d.o.o. on September 11, 2020 in Menges. 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 11, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Menges (Slovenia)

Additional Details

Mutual Recognition Agreement (MRA)