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Tcon with RDT re: STN 125335/0 Email, July 19, 2011 - Anascorp

 

From:                     Fisher, Robert
Sent:                      Tuesday, July 19, 2011 12:23 PM
To:                         Shields, Mark
Cc:                         Cordaro, Debbie
Subject:                 Tcon with RDT 1200 19 July 2011 re: STN 125335/0
 
Hi Mark. I just had a quick tcon with Jennifer at RDT to discuss the submission that came in yesterday.   I explained to her that the new cresol and sulfate specifications (expressed as mg/vial) should not exceed the old specifications (expressed as a percentage) when the vial fill volume is taken into account. I also indicated that we may need an additional revision on the lot release template due to a potential typo in the specifications. 
 
Could you post this to the file for 125335/0? Thanks…
 
 
 
Robert W. Fisher, Ph.D.
Staff Fellow, Laboratory of Plasma Derivatives
FDA/CBER/OBRR/DH
202-329-3957
Robert.Fisher@fda.hhs.gov