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1200973

Janssen Ortho LLC — FEI 3002942061

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 28, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Gurabo, PR (United States)

Facility

Other inspections at this facility

  • 1063744 (VAI Tue Aug 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1012089 (VAI Fri May 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 930456 (VAI Fri May 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 819622 (VAI Fri Feb 22 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 729698 (VAI Mon Jun 13 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
104921 CFR 211.22(a)Approve or reject components, products
202721 CFR 211.192Investigations of discrepancies, failures
344521 CFR 211.65(a)Equipment construction - reactive surfaces