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Mid-Cycle Review Memo, January 26, 2010 - MenHibrix

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
Sponsor: GlaxsoSmithKline
Product: MenHibrix [Meningococcal Groups C and Y and
Haemophilus B Tetanus Toxoid Conjugate Vaccine] BLA/STN: 125363/0


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.



Robert Wesley
Consumer Safety Officer