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769993

XGen Pharmaceuticals DJB, Inc. — FEI 3005548067

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 8, 2012
Fiscal Year
2012
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))
  • 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))

Citations

IDCFRDescription
113321 CFR 211.25(a)GMP Training Frequency
241921 CFR 211.198(a)Complaint Handling Procedure
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
891221 CFR 314.81(b)(2)Timely submission