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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Bioresearch Monitoring Midcycle Review Memo, April 19, 2011 - EVARREST

MEMORANDUM  DEPARTMENT OF HEALTH AND HUMAN SERVICES
                               Public Health Service
                               Food and Drug Administration
                               Center for Biologics Evaluation and Research
             
DATE:  April 19, 2011

FROM: Dennis T. Cato, Bioresearch Monitoring, HFM-664
             Division of Inspections and Surveillance
             Office of Compliance and Biologics Quality

Telephone:  301-827-2588  Fax:  301-827-6748

THROUGH: Patricia Holobaugh, Bioresearch Monitoring Branch Chief, HFM-664

SUBJECT: Bioresearch Monitoring Midcycle Review Memo

BLA/STN:   125392/0

Sponsor:   Omrix Biopharmaceuticals, Ltd.

Product: Fibrin Pad

TO:  Sonday Kelly   HFM-380
        Natalya Ananyeva  HFM-392
        Kimberly Lindsey  HFM-392

BIMO issued inspection assignments for three Clinical Investigators at the following study sites:

Site Number Study SiteLocationNumber of SubjectsForm FDA 483 Issued
Site 011R. Adams Cowley Shock Trauma CenterBaltimore, MD 18Yes
Site 014Medical College of Georgia, Section of UrologyAugusta, Georgia28No
Site 022University of Alabama, Division of Cardiothoracic SurgeryBirmingham, Alabama32Yes

All three of the above inspection assignments have been completed.  Two of the three Establishment Inspection Reports (EIRs) are pending receipt and review.  We will update the review committee with the pending results as soon as they are available.

 

    _______________________ 
Dennis T. Cato
Consumer Safety Officer


Distribution
 

Paper Copies:
Cc: HFM-664 Access/Chron

Electronic Copies:
HFM-380  Sonday Kelly   
HFM-392  Natalya Ananyeva  
HFM-392  Kimberly Lindsey  

 

 

Draft:  Cato:  4/18/2011
Reviewed:  Holobaugh:  4/19/2011