
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
 
-(b)(4)-, 
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. 
 

Thanks, 
 

Debbie
