FDA Inspection 1123814 — Xellia Pharmaceuticals ApS

Xellia Pharmaceuticals ApS — FEI 3002806860

The FDA completed an inspection of Xellia Pharmaceuticals ApS on October 25, 2019 in Copenhagen S. 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
October 25, 2019
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Copenhagen S (Denmark)

Additional Details

Mutual Recognition Agreement (MRA)