FDA Inspection 813923 — Janssen Biologics B.V.

Janssen Biologics B.V. — FEI 3002806632

The FDA completed an inspection of Janssen Biologics B.V. on September 28, 2012 in Leiden. 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 28, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Leiden (Netherlands)