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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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


DATESeptember 28, 2009
FROMBhanu Kannan, Bioresearch Monitoring Branch, HFM-664
Division of Inspections and Surveillance
Office of Compliance and Biologics Quality
THROUGHPatricia Holobaugh, Chief, Bioresearch Monitoring Branch, HFM-664
TOPei 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