
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



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
