Midcycle review: Status of Bioresearch Monitoring Inspections - Hizentra, September 28, 2009

 

 

 

MEMORANDUM

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research

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DATE	September 28, 2009
FROM	Bhanu Kannan, Bioresearch Monitoring Branch, HFM-664 Division of Inspections and Surveillance Office of Compliance and Biologics Quality
THROUGH	Patricia Holobaugh, Chief, Bioresearch Monitoring Branch, HFM-664
TO	Pei Zhang, HFM-345                          Scientific Lead /Chair, BLA Licensing Committee
SUBJECT	Midcycle review Status of Bioresearch Monitoring Inspections SPONSOR:    CSL Behring LLC  PRODUCT:    Immune Globulin Subcutaneous (Human), 20% Liquid (IgPro20) BLA:               STN 125350/0

Review status:
We issued inspection assignments on July 30, 2009 to inspect the clinical investigators conducting investigations at sites #1 and #15.  The inspections are pending and a review will be conducted after the completion of the inspections and the receipt of the inspection reports.

Should you have any questions or comments about the contents of this memo or any aspect of Bioresearch Monitoring, please contact me at 301-827-6188.

                                                         
Bhanu Kannan