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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Questions Email, March 5, 2009 - Anascorp

From: Cordaro, Debbie [mailto:Debbie.Cordaro@fda.hhs.gov]
Sent: Thursday, March 05, 2009 6:32 PM
To: ----(b)(4)----
Subject: Question about STN 125335
Importance: High
The reviewers need you to help them find in this submission your process
validation for bulk drug substance manufacture, and clarify which lots are your
process validation (conformance) lots. 
Please send this information on 3/6/09.