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954335

XGen Pharmaceuticals DJB, Inc. — FEI 3005548067

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 23, 2015
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Horseheads, NY (United States)

Facility

Other inspections at this facility

  • 1233326 (VAI Fri Jun 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))
  • 769993 (VAI Thu Mar 08 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
241921 CFR 211.198(a)Complaint Handling Procedure
672921 CFR 314.80(b)Failure to submit follow-up information to FDA
673021 CFR 314.80(b)Failure to develop written procedures
682321 CFR 314.80(c)Failure by applicant to report ADE
684121 CFR 314.80(f)(1)Incomplete patient information on ICSR