Randa Melhem - FDA Investigator Report

Designation: CONSUMER SAFETY OFFICER

Duty Station: Silver Spring MD 20993-0002

Organizations: DHHS FDA CBER CBER OCBQ DMPQ BII

Overview Statistics

17
Total Inspections
15
Total 483s Issued
0
Warning Letters Issued

Inspection Details

Longest Inspection: 10 days
Shortest Inspection: 1 days
Average Length: 2.8 days

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Randa Melhem's Recent Inspections

DateCompanyCityCountryFEI Number483
2019-08-02Duke Medical Center-Carolinas Cord Blood Bank and Stem Cell LaboratoryDurhamUnited States3002663011
2018-11-13GlaxoSmithKline BiologicalsSaint-Amand-Les-EauxFrance3014752610
2017-04-07Novartis Pharmaceuticals CorporationMorris PlainsUnited States3010353512
2016-06-24Baxalta US IncorporatedLos AngelesUnited States2011021
2014-10-23Baxalta Belgium Manufacturing SALessinesBelgium3002806503
2013-10-25Bio Products Laboratory Ltd.BorehamwoodUnited Kingdom1000184635
2013-04-12Novo Nordisk A/S - 25a-BHillerodDenmark3003131673
2012-08-07Octapharma Pharmazeutika Produktions GmbHViennaAustria3002809097
2012-07-30Octapharma ABStockholmSweden3005559915
2012-04-20Seqirus IncHolly SpringsUnited States3007867647

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Randa Melhem - Co-Inspectors

NameInspectionsLast Inspection
Destry M Sillivan32011
Lily Y Koo22019
Jie He22012
Anthony F Lorenzo22012
Sukhanya Jayachandra12019
Thomas P Finn12019
Ekaterina Allen12019
Prabhu P Raju12019
Ashley J Burns12017
Joan Johnson12017
Jeremy L Wally12014
Pankaj H Amin12012
Esra Toussaint12011
Priscilla M Pastrana12011
Nawab A Siddiqui12010
Joseph D Doleski12010
Nancy T Waites12010
Gang Wang12010
James A Crim12009

Randa Melhem's Active Locations

  • United States
  • Israel
  • United Kingdom
  • Sweden
  • Austria
  • Denmark
  • France
  • Switzerland
  • Belgium

Randa Melhem's Year-wise Inspection Count

  • 2009:1 inspections
  • 2010:3 inspections
  • 2011:3 inspections
  • 2012:3 inspections
  • 2013:2 inspections
  • 2014:1 inspections
  • 2016:1 inspections
  • 2017:1 inspections
  • 2018:1 inspections
  • 2019:1 inspections
Last Updated: 2025-05-14 06:11:22