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FDA Inspection 1265723 — Janssen Biotech, Inc.

Janssen Biotech, Inc. — FEI 3001610451

The FDA completed an inspection of Janssen Biotech, Inc. on March 10, 2025 in Malvern, PA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). Product area: Biologics.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
March 10, 2025
Fiscal Year
2025
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Malvern, PA (United States)

Facility

Other inspections at this facility

  • 1276933 (VAI Tue Jul 29 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