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

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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.