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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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5/16/2007 Summary of Teleconference - XYNTHA

MEMORANDUM

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Date: May 16, 2007
From: Robert Stevenson, HFM-675
To: STN 125264 / 0
Subject: Summary of Teleconference
   
Date / Time: May 16, 2007 1139 - 1142ET
FDA Participants: Robert Stevenson
Applicant Participants: Joyce Schwenk, Senior Manager, Global Regulatory Affairs, Wyeth
Objectives: To submit Information Request

I requested that Ms. Schwenk send me an inspectional history chart for the three manufacturing facilities located in
---------------------------------------------------------- I ask her to provide the inspection dates, inspector/investigator names, purpose of inspection (specific product or biennial), and inspection endorsement. I indicated that I would verify the information against FDA internal data bases and determine if I could waive any of the manufacturing sites from undergoing a pre-license inspection. I provided her with my e-mail address.