FDA Inspection 1220158 — Janssen Pharmaceutica NV

Janssen Pharmaceutica NV — FEI 3002807334

The FDA completed an inspection of Janssen Pharmaceutica NV on February 3, 2021 in Olen. 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
February 3, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Olen (Belgium)

Additional Details

Mutual Recognition Agreement (MRA)