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1100288

XGen Pharmaceuticals DJB, Inc. — FEI 3005548067

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 22, 2019
Fiscal Year
2019
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

  • 1233326 (VAI Fri Jun 14 2024 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
673021 CFR 314.80(b)Failure to develop written procedures
683221 CFR 314.80(c)(2)Late submission of annual safety reports