Midcycle review: Status of Bioresearch Monitoring Inspections - Hizentra, September 28, 2009
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
Status of Bioresearch Monitoring Inspections
SPONSOR: CSL Behring LLC
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.