System Info - 106872 MCWATTERS, BERNARD 05-Oct-2009 14:47:14 MCWATTERS
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125297/0 Office: OVRR
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 09-JUL-2009 12:00 AM Initiated by FDA? Yes
Author: BERNARD MCWATTERS
Question regarding the outstanding inspectional issues.
FDA Participants: Bernard McWatters
Non-FDA Participants: Joanne Totosy de Zepetnek
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: McWatters, Bernard [mailto:Bernard.McWatters@fda.hhs.gov]
Sent: Thursday, July 09, 2009 2:54 PM
To: Totosy de Zepetnek, Joanne
Cc: Cheung, Anissa; Olin, Rebecca
Subject: RE: Summary of July 6, 2009 discussion re Agrippal BLA 125297 Complete Response
I just had a chance to speak with Rebecca and Anissa about your outstanding inspectional issues. For issue 1: In the cover letter to your complete response, you indicated that you could submit the hold time validation data in July 2009. Why is this not happening? Have you not been able to produceb(4)lots of the B strain? If you have,then you should have hold time data to submit. Issue 2: Rebecca asked me why it would take you this long to perform a cleaning validation study of the inoculation machine? With the production at this time, you should constantly be using and cleaning this machine, so cleaning validation data should not take too long to get during production, unless there is a problem. Is there a problem? Please send me clarifications to these points so that we can make an informed decision about allowing them to be post marketing commitments. Rebecca is still in the process of reviewing the -b(4)- filling line data and did not have any comments at this time regarding that issue.
Bernard J.P. McWatters, Ph.D.
1401 Rockville Pike rm. 379N
Rockville, MD 20852
Office - 301-827-3921