Product Approval Information
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.