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1233326

XGen Pharmaceuticals DJB, Inc. — FEI 3005548067

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 14, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Horseheads, NY (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1100288 (VAI Thu Aug 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1056541 (VAI Fri Jun 22 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1041478 (VAI Fri Feb 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 954335 (VAI Wed Dec 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 769993 (VAI Thu Mar 08 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1802821 CFR 314.80(f)(4)Incomplete initial reporter information on ICSR
1803321 CFR 314.80(g)(1)Failure to submit electronic format safety report
673021 CFR 314.80(b)Failure to develop written procedures
684121 CFR 314.80(f)(1)Incomplete patient information on ICSR