Record of Telephone Conversation - Cervarix, June 1, 2007

Record of Telephone Conversation
STN Number: 125259/0
Manufacturer: GSK
Product: CERVARIX
To: File
From: Helen S. Gemignani, Regulatory Project Manager
Subject: Notice of Inspection Decision
Telecon Date: June 1, 2007 Telecon Time: 2:00 pm
Telecon Initiated by: Helen S. Gemignani
Contact Phone: Terry Ward 610 787-3769
Signature:
Summary of Telecon
I called Terry Ward to inform her that FDA will not be performing a Prior Approval Inspection of their facility in Montana which manufactures Monophosphoryl Lipid A (MPL) adjuvant.
End of Teleconference
Action Items
• none
FDA Participants
• Helen S. Gemignani
Non-FDA Participants
• Terry Ward