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1101407

Hikma Pharmaceuticals LLC — FEI 3002806351

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 5, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Amman (Jordan)

Facility

Other inspections at this facility

  • 981353 (VAI Wed Jul 27 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 935111 (VAI Thu Jun 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 782232 (NAI Thu Apr 12 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 645014 (NAI Thu Feb 04 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
189021 CFR 211.165(e)Test methods
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance