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Haemophilia / Coagulation system / Viruses / CSL Behring / Virology / Transfusion medicine / Factor XIII deficiency / Factor X / Behring / Biology / Medicine / Blood


Summary Basis for Regulatory Action
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City

Marburg / /

Company

Case Management / Introduction CSL Behring GmbH / FXIII Concentrate (Human) Manufacturing / CSL Behring GmbH / /

Country

Germany / Guinea / United States / /

Event

FDA Phase / Product Recall / Product Issues / /

Facility

CSL Behring facility / Building (b)(4) / CSL Behring GmbH facility / /

IndustryTerm

rubber stoppers / final drug product / protein product / manufacturing pool / end product / reconstitution device / rubber stopper / transfer device / manufacturing process / needless transfer device / final product / manufacturing procedure / individual processing steps / opalescent solution / manufacturing steps / manufacturing / manufacturing site / carrier molecules / final bulk solution / /

MedicalCondition

HIV / XIII deficiency / HBV / sterility / herpes / hepatitis B / Hemophilia A / HCV / bovine viral diarrhea virus / /

MedicalTreatment

plasmapheresis / /

Movie

Half-life / /

MusicGroup

Yes / /

Organization

CBER office of Compliance and Biologics Quality / Division of Case Management / CorifactTM administration / Approval Jay S. Epstein____________________________ Offices Signatory Authority / FDA / Signatory Authority / European Union / /

Person

John Eltermann / Tim Lee / Alan C. Ou / Jay S. Epstein / Michael Brony / Mahmood Epidemiology Alan / Renee Rees Pharmacology / Daniela J. Vanco / Nisha Jain / /

Position

General / Chair / Committee / /

Product

Sodium chloride / Factor XIII / Sterile Water for Injection / CorifactTM / Factor XIII Concentrate / /

Region

West Nile / /

Technology

antibodies / process control / pharmacokinetics / Ion exchange / /

SocialTag