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Vaccines, Blood & Biologics

Record of Telephone Conversation, October 24, 2012 - HPC, Cord Blood BLA 125432


HPC, Cord Blood
LifeSouth Community Blood Centers, Inc.
Telecon Date/Time: 24-Oct-2012 01:00 PM        Initiated by FDA? Yes
Telephone Number: -------(b)(4)--------
Meeting ID: --------------(b)(4)----------------
Communication Categorie(s):
1. Information Request
Telecon Summary:
FDA requested a teleconfernce to discuss outstanding deficiencies, sterility validation, and flow cytometry
FDA Participants: Mohammad Heidaran, Ph.D., Biologist (CBER/OCTGT/DCGT)
      Eric Dollins, Ph.D., Biologist (CBER/OCTGT/DCGT)
      Safa Karandish, B.S., CSO (CBER/OCTGT/DHT)
Non-FDA Participants: Kathleen Sazama (Medical Officer)
                                     Jill Evans, (Vice President of Quality)
                                     Amy Lambert, (Manager Cellular Therapies)
                                     Tammy Lawson, (Validation Coordinator)
                                     Evan Basler
                                     Ed Downey
                                     Hosea Rodriquez
                                     Tamara Cannady
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Telecon Body:
FDA requested a teleconference with the sponsor to discuss outstanding deficiencies and flow cytometry validation. At the start of the meeting, FDA reminded the sponsor of the importance of submitting their responses as there are time limits for review. The sponsor acknowledged that there is a time line and agreed to get the information in as soon as possible.
1.           SOP for linkage of DIN with maternal ID:
FDA requested the sponsor to provide a description of how they are going to maintain linkage between the DIN and maternal ID at various points of the cord blood collection and processing. The sponsor stated that they will provide a detailed description of this process accompanied by all relevant SOPs.
2.           SOP reflecting exclusion of the mother receiving antibiotics:
FDA requested that the sponsor provide their updated SOP clarifying that the mother is excluded even if they are on prophylactic antibiotics. The sponsor agreed..
3.           Package label ISBT 128 compliant:
FDA informed the sponsor that it appears that, they are not in full compliance with ISBT 128 for the full package label. FDA asked how the sponsor planned to address this. The sponsor replied that they are not easily able to address this because they are not technically able to print barcodes for the cellular therapy components, but they can provide the barcode labels for the container. Again FDA reiterated that they need to be fully able to implement ISBT or request a NDC number for the package label. The sponsor requested information on how to request a NDC number and FDA stated that they would get back to them after further internal discussion.
4.           Proprietary Name request:
FDA asked that the sponsor submit this request in soon as there is a 90 day review clock for this. The sponsor asked if they could submit this request after approval. FDA replied yes and that it would have to be submitted as a PAS.
5.           Revalidation of emergency recovery:
6.           Flow Cytometry:
7.           Sterility Validation:
(b)(4) document 40b


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