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