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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Concluding Review Memo/E-mail for Rota CMC

From: Feigelstock, Dino
Sent: Wednesday, April 02, 2008 12:12 PM
To: Henchal, Laraine; Levis, Robin
Cc: Feinstone, Stephen; Krause, Philip; Vujcic, Luba; Weir, Jerry P.
Subject: concluding review memo/e-mail for Rota CMC


Upon further discussion and review of the --------------- step and the in process controls to measure product quality after ---------------, it has been concluded that GSK's use of the - --------- is appropriate and there are no remaining issues regarding this step in manufacturing.



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