Home / Inspections / 1056541

1056541

XGen Pharmaceuticals DJB, Inc. — FEI 3005548067

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 22, 2018
Fiscal Year
2018
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))
  • 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
191221 CFR 211.166(a)Written program not followed
433621 CFR 211.150Written distribution procedure
438921 CFR 211.198(a)Procedures to be written and followed