|DATE||January 26, 2010|
|FROM||Robert Wesley, Bioresearch Monitoring, HFM-664|
Division of Inspections and Surveillance
Office of Compliance and Biologics Quality
|THROUGH||Patricia Holobaugh, BIMO Branch Chief, HFM-664|
|TO|| Joseph Temenak, Ph.D., HFM-481, Chair|
Jason Humbert, HFM-481, RPM
|SUBJECT||Mid-Cycle Review Memo|
Product: MenHibrix [Meningococcal Groups C and Y and
Haemophilus B Tetanus Toxoid Conjugate Vaccine] BLA/STN: 125363/0
MIDCYCLE REVIEW SUMMARY
Assignments for three clinical investigators were issued on November 9, 2009, with a requested due date of February 15, 2010. As of January 25, 2010, all inspections assignments have been assigned, but none of the inspections have been begun.
A serology testing laboratory assignment was issued on December 11, 2009 with a requested completion date of April 19, 2010. That inspection request has not been assigned to a District/Investigator at this time.
The BLA committee will be apprised of any significant deviations noted during the inspections. A final BLA review summary statement will be prepared following submission and review of all inspection reports.
Consumer Safety Officer