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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Record of Telephone Conversation, July 16, 2012 - HPC, Cord Blood BLA 125432

 

Product:
HPC, Cord Blood
Applicant:
LifeSouth Community Blood Centers, Inc.
Telecon Date/Time: 16-Jul-2012 11:00 AM        Initiated by FDA? Yes
Telephone Number: -----(b)(4)-------
------------------(b)(4)-------------------------
Communication Categorie(s):
1. Inspection Related
 
Author: CANDACE JARVIS
Telecon Summary:
FDA wanted to set timeframe for facilty inspection
FDA Participants: Grace M.B. Deneke, CSO/DMPQ/OCBQ/CBER/FDA
      Marion Michaelis, Team Leader (CBER/OCBQ/DMPQ)
      Mohammed Heidaran, Ph.D., Biologist (CBER/OCTGT/DCGT)
      Eric Dollins, Ph.D., Biologist (CBER/OCTGT/DCGT)
                              Candice Jarvis, RPM (CBER/OCTGT)
Non-FDA Participants: Jill Evans, Vice President of Quality
                                       Nancy Eckert (CEO)
                                       Kathleen Sazama (Medical Officer)
                                          Lori Masingil (Technical Communications Manager)
                              Juan Merayo-Rodriquez (Medical Director)
 
Trans-BLA Group: No
 
Related STNs: None
Related PMCs: None
Telecon Body:
FDA requested a brief teleconference with the sponsor to propose a time for a facility inspection. FDA asked the sponsor what was their manufacturing capacity per day at full scale. The sponsor initially stated ---(b)(4)----- but modified it to ---(b)(4)- when asked to perform the maximum capacity during inspection. Sponsor stated that they can perform (b)4 during the week of the inspection. FDA was satisfied with the capacity and suggested the week of September 24-28, 2012 for the facility inspection and the sponsor agreed that those dates were feasible for them. The sponsor listed Jill Evans, Vice President of Quality as the primary point of contact for the inspection. FDA notified sponsor that at least 4 or 5 inspectors will be on the inspection. FDA asked if there were any special measures that needed to be met (i.e., security) for their visit. The sponsor stated that no special measures were needed to gain entry to the facility and that they would provide visitors access to the building. FDA requested sponsor to provide three hotel recommendations in preparation for the inspection. FDA notified sponsor that there will be future teleconference to discuss pre-positioning of documents prior to the inspection that will be scheduled through Candice. The call ended cordially.