Home / Inspections / 1126291

FDA Inspection 1126291 — Janssen Biologics B.V.

Janssen Biologics B.V. — FEI 3002806632

The FDA completed an inspection of Janssen Biologics B.V. on October 11, 2018 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
October 11, 2018
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Leiden (Netherlands)

Additional Details

Mutual Recognition Agreement (MRA)

Facility

Other inspections at this facility

  • 1272273 (VAI Thu Jun 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1076442 (NAI Fri Jun 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 975458 (NAI Fri May 27 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 891657 (VAI Fri Jul 11 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 813923 (VAI Fri Sep 28 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources