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1225275

Janssen Pharmaceuticals Inc. — FEI 2211100

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 14, 2023
Fiscal Year
2024
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Raritan, NJ (United States)

Facility

Other inspections at this facility

  • 1175643 (NAI Fri Jun 17 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 998113 (NAI Thu Jan 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 965139 (NAI Fri Jan 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 833775 (NAI Tue May 21 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 787093 (NAI Tue Jun 19 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111121 CFR 211.25(a)Training , Education , Experience overall
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
360321 CFR 211.160(b)Scientifically sound laboratory controls
908621 CFR 600.14(a)(1)Who must report - manufacturer