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Vaccines, Blood & Biologics
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