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2004N-0408: REGULATORY SITE VISIT TRAINING
PROGRAM
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| Document #
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| Received Date
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| Filed
Date
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| Submitter Code
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| Submitter
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| FR
Date
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| FR
Page
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| Comment Date
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| Files
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| Remarks
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| N1
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| 09/22/2004
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| FDA
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| FDA
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| 09/23/2004
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| 57033-57034
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| 10/25/2004
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| pdf
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| Signature:
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| SHUREN, JEFFREY
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| EC1
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| 10/01/2004
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| 09/30/2004
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| Other Organization
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| Midwest
Eye-Banks
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| htm
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| Signature:
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| Tennant, Bradley
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| EC2
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| 10/01/2004
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| 09/30/2004
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| Private
Industry
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| Mayo Clinic
Rochester Transfusion Medicine
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| htm
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| Signature:
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| Tran, Sheryl
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| EC3
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| 10/02/2004
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| 10/01/2004
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| Drug Industry
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| Merck
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| htm
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| Signature:
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| Rosolowsky, Mark
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| C1
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| 10/04/2004
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| 10/01/2004
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| International Industry
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| Aseptic
Technologies SA
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| pdf
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| Signature:
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| Christian Vandecasserie,
PhD
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| EMC1
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| 09/29/2004
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| 09/29/2004
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| Private
Industry
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| Midwest
Eye-Banks
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| txt
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| Signature:
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| Bradley Tennant
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| EC4
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| 10/06/2004
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| 10/06/2004
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| Other Organization
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| Gulf Coast
Regional Blood Center
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| htm
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| Signature:
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| See, Rebecca
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| EC5
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| 10/07/2004
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| 10/06/2004
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| Academia
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| University
of Washington
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| htm
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| Signature:
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| Lindgren, Catherine
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| EC6
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| 10/08/2004
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| 10/07/2004
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| Drug Association
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| The Institute
for Transfusion Medicine
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| htm
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| Signature:
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| Tata, Roxanne
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| LET1
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| 10/13/2004
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| 10/07/2004
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| Drug Industry
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| LifeSouth
Community Blood Centers, Inc.
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| pdf
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| Signature:
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| Elizabeth A. Crews
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| C2
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| 10/21/2004
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| 10/21/2004
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| Private
Industry
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| SICOR Inc.
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| pdf
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| Signature:
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| Suzanne M. Sensabaugh,MS,MBA
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| EMC2
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| 10/21/2004
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| 10/21/2004
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| Drug Industry
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| Panacea
Biotec Ltd.
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| txt
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| Signature:
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| Panacea Biotec Ltd.
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| EMC3
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| 10/25/2004
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| 10/25/2004
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| Drug Industry
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| Merck &
Co., Inc.
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| txt,
Attachment pdf, doc
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| Signature:
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| Keith Chirgwin, MD
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| EC7
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| 10/19/2004
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| 10/18/2004
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| Drug Industry
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| St. Jude
Childrens Research Hospital
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| htm
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| Signature:
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| Coleman, John
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| EC8
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| 10/19/2004
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| 10/18/2004
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| Drug Industry
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| SICOR, Inc.
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| htm
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| Signature:
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| Sensabaugh, Suzanne
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| EC9
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| 10/19/2004
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| 10/18/2004
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| Private
Industry
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| LifeCell
Corporation
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| htm
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| Signature:
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| Shriver, David
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| EC10
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| 10/21/2004
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| 10/20/2004
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| Drug Industry
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| Indiana
Blood Center
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| htm
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| Signature:
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| Cunningham, Kathie
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| EC11
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| 10/22/2004
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| 10/21/2004
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| Private
Industry
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| Mayo Clinic
Rochester Transfusion Medicine
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| htm
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| Signature:
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| Tran, Sheryl
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| EC12
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| 10/23/2004
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| 10/22/2004
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| Drug Industry
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| Neuronyx,
Inc.
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| htm
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| Signature:
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| Scheffler, Denise
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Page last updated
December 9, 2004
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