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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Report of Telephone Conversation, October 12, 2011 - Hemacord

 

Date/Time of Call:                      October 12, 2011 @ 2:00 A.M.  
 
CBER Representative:                     Mercy Quagraine, Mohommad Heidaran (DMPQ)
                       
Organization Representative:       Pablo Rubenstein, Andromachi Scaradavou, Mike Zdanowski, Ludi Dobrila
 
 
Organization:                                    New York Blood Center Inc.
 
Subject:                                   Follow up on NYBC’s proposal for Retention Samples
 
STN:                                         125397/0
                       
 
Telecon with NYBC October 12, 2011 2-3 PM:
 
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
Sponsor will send his written proposal via email and will wait for FDA response before initiating ‘Change Management Control’ to update their SOPs.
 
On a follow up question on their batch records approach, the agency (DMPQ) agreed with their approach. Regarding the status of their NDC #, Sponsor indicated that they were still in the process of securing the NDC #.