FDA Inspection 1203728 — Janssen Pharmaceutica, N.V.

Janssen Pharmaceutica, N.V. — FEI 3002807336

The FDA completed an inspection of Janssen Pharmaceutica, N.V. on July 2, 2021 in Beerse. 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
July 2, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Beerse (Belgium)

Additional Details

Mutual Recognition Agreement (MRA)