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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Record of Telephone Conversation, April 26, 2013 - HPC, Cord Blood BLA 125432

 

Product:
HPC, Cord Blood
Applicant:
LifeSouth Community Blood Centers, Inc.
Telecon Date/Time: 26-Apr-2013 02:00 PM        Initiated by FDA? Yes
Telephone Number: ----(b)(4)------
Communication Categorie(s):
1. Information Request
 
Author: MOHAMMED HEIDARAN
Telecon Summary:
Telecon to discuss (b)(4) assay and regional centers
FDA Participants: None
Non-FDA Participants: None
Trans-BLA Group: No
 
Related STNs: None
Related PMCs: None
Telecon Body:
Summary regarding --------(b)(4)----------------------- assay:
 
The applicant was asked to verify several aspects related to the (b)(4) assay:
 
  1. Whether the acceptance criteria for the assay is ----(b)(4)--------------.
 
  • The applicant verified the acceptance criteria is -------(b)(4)------
 
  1. Whether every single cord blood unit is tested with the (b)(4) assay:
 
  • The applicant verified that every unit is tested. The applicant also noted that if the unit is negative for ------(b)(4)-----, the unit is discarded and will not be accepted as a licensed product.
 
FDA explained that the (b)(4) assay is not listed in their BLA as a lot release test; however, since they are testing every unit with an acceptance criteria of ---(b)(4)------------------- and units which test negative are discarded, it appears in fact to be a lot release test. The applicant responded in agreement that the (b)(4) assay is a lot release test and further stated that they have recently updated their lot release testing table to reflect this. FDA requested that the applicant send a copy of their updated lot release table which includes the (b)(4) assay.
 
Summary Regarding the Regional Centers:
 
LifeSouth was also asked about the SOPP for transport of cord blood units from hospitals to the processing center via regional centers. LifeSouth indicated that all regional centers are equipped with 4 oC refrigerators and true pack boxes are stored in refrigerators until they are transported via air to the processing centers. Telecon ended cordially.