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 
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Information Withheld Per the Privacy Act)---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

BACKGROUND 
-----------------------------------------------(Information Withheld Per the Privacy Act)---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


 

Redact entire page (Information Withheld Per the Privacy Act)

 

 

 

 

 

 

 

 

 

 

BIMO ADMINISTRATIVE FOLLOW-UP
------------------------------------------------------------(Information Withheld Per the Privacy Act)---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.

 

_____________________
Dennis T. Cato
Consumer Safety Officer
