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FDA Inspection 1276933 — Janssen Biotech, Inc.

Janssen Biotech, Inc. — FEI 3001610451

The FDA completed an inspection of Janssen Biotech, Inc. on July 29, 2025 in Malvern, PA. 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 29, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Malvern, PA (United States)

Facility

Other inspections at this facility

  • 1265723 (NAI Mon Mar 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1077487 (NAI Fri Nov 30 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1046499 (VAI Mon Mar 05 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1031776 (VAI Tue Nov 21 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1007329 (NAI Mon Feb 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources