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1012089

Janssen Ortho LLC — FEI 3002942061

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 26, 2017
Fiscal Year
2017
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))
  • 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
126321 CFR 211.68(b)Computer control of master formula records
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
135821 CFR 211.100(b)SOPs not followed / documented
180921 CFR 211.160(a)Following/documenting laboratory controls
202721 CFR 211.192Investigations of discrepancies, failures
203121 CFR 211.194(a)Complete test data included in records
241921 CFR 211.198(a)Complaint Handling Procedure
360321 CFR 211.160(b)Scientifically sound laboratory controls