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930456

Janssen Ortho LLC — FEI 3002942061

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 29, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Gurabo, PR (United States)

Facility

Other inspections at this facility

  • 1200973 (VAI Tue Mar 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))
  • 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
172521 CFR 211.134(c)Examinations documented
434521 CFR 211.160(b)(1)Samples (various types) representative, identified properly
435121 CFR 211.160(b)(3)Drug products - samples representative, identified properly