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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Memo - Final Summary Review, December 29, 2010 - Corifact

DATE:          December 29, 2010

FROM:         Dennis T. Cato, Bioresearch Monitoring, HFM-664
                 Division of Inspections and Surveillance
                 Office of Compliance and Biologics Quality
                 Telephone: 301-827-2588               Fax: 301-827-6748

THROUGH:   Patricia Holobaugh
                 Bioresearch Monitoring Branch Chief, HFM-664

SUBJECT:    Bioresearch Monitoring Inspection Results

BLA:           STN 125385/0

Sponsor:     CSL Behring LLC

Product:     Factor XIII Concentrate (Human)

TO:           Ze Peng                                 HFM-392
                Nannette Cagungun              HFM-380
                Daniela Vanco                      HFM-392

SUMMARY
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BACKGROUND
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BIMO ADMINISTRATIVE FOLLOW-UP
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_____________________
Dennis T. Cato
Consumer Safety Officer