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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Record of Telephone Conversation, November 8, 2012am - HPC, Cord Blood BLA 125432

 

Submission Type: BLA    Submission ID: 125432/0    Office: OCTGT
Product:
HPC, Cord Blood
Applicant:
LifeSouth Community Blood Centers, Inc.
Telecon Date/Time: 08-Nov-2012 10:00 AM        Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):
1. Advice
 
Author: CANDACE JARVIS
Telecon Summary:
Telecon with the sponsor to provide advice on their sterility validation plan and labeling.
FDA Participants: Mohammed Heidaran, Ph.D., Biologist (CBER/OCTGT/DCGT)
      Eric Dollins, Ph.D., Biologist (CBER/OCTGT/DCGT)
      Joydeep Ghosh, Ph.D., Microbiologist (CBER/OCTGT/DCGT)
 
Non-FDA Participants: Jill Evans, (Vice President of Quality)
                                     Amy Lambert, (Manager Cellular Therapies)
                                     Tammy Lawson, (Validation Coordinator)
                                     Evan Basler
                                     Lori Masingil
 Juan Merayo-Rodriguez
                                     Ed Downey
 
Trans-BLA Group: No
 
Related STNs: None
Related PMCs: None
Telecon Body:
FDA requested brief teleconference with Life South to discuss their sterility validation plan and to follow-up with them regarding ISBT labeling.
 
FDA mentioned that they were not satisfied with the sponsor’s proposed sterility test sample volume and wanted to offer some suggestions for improvement. FDA suggested that the sponsor could use the RBC-plasma by-product (majority of the by-product should be RBC) instead of the final product as their test sample. FDA also recommended using           -------------------(b)(4)-------------------------------------------------. With regards to the incubation temperature, FDA suggested that the sponsor could just use the ---(b)(4)---- incubation temperature to do the sterility test and assay revalidation. FDA also suggested that the sponsor could use only (b)(4) test microorganisms --------------------------------------------------------------------------------------------------(b)(4)----------------------------------------------------------------------------------------------------------------------------------------------------- used so far to revalidate their sterility test using the (b)(4) of by-product. FDA further suggested that the sponsor uses 2 lots of media in the revalidation plan and at least duplicate samples for each lot which would total to a minimum 4 samples per test microorganism.  FDA also recommended the sponsor using triplicate plate counts to verify the less than ---(b)(4)------ inoculum level. FDA extended the option for the sponsor to send in their revalidation plan by email for further review. The sponsor agreed to all of the above FDA’s suggestions/recommendations and opted to submit the revalidation plan by email for further review.
 
With regard to labeling, FDA informed the sponsor that as it stands now, they are not ISBT compliant and that they needed to make a decision soon as to which route they were planning to take with regard to the labeling. The sponsor stated that they have a contractor coming in on December 4th to give a presentation on a label maker that prints 4X4 labels and they should have a decision after that date. The sponsor asked if it would be wise to submit the NDC request just in case what the contractor presents is not feasible for FDA. FDA replied that they need to decide on which route to take, but for warned them that they do not have much time to submit because we still have to review the data. FDA also discussed the timeline with the sponsor and explained that major outstanding information submitted after December 18th may trigger a 3-month extension of the review clock. But the agency decides whether to extend the review clock in response to such amendments. This decision is based on a variety of factors (e.g., content of the amendments, FDA workload and resources, existence of other known deficiencies that may affect approval and have not been addressed by the amendment).,The sponsor stated that they understood and noted that they had to make some decisions soon and would notify FDA on what their targeted timelines would be and would set up a teleconference with us to determine if they are feasible.
‘The call ended cordially.