Record of Telephone Conversation, July 30, 2012 - ALLOCORD


Product:
HPC, Cord Blood
 
Applicant:
SSM Cardinal Glennon Children's Medical Center
 
Telecon Date/Time: 30-Jul-2012 01:00 PM        Initiated by FDA? Yes
 
Telephone Number: --------(b)(4)----------
 
Communication Categorie(s):
1. Information Request
 
Author: BRENTON MCCRIGHT
Telecon Summary:
Status of St. Luke manufacturing site and product labling
St. Louis Cord Blood Bank (SLCBB): Donna Regan, Kathy Fortune, William Ferguson
 
FDA: Nancy Waites, Brian Niland, Lori Tull, Keith Wonnacott, Kim Benton, Brent McCright
 
SLCBB: SLCBB feels that they will be able to comply with regulatory requirements more quickly if they remove the St. Luke’s, Kansas City (SLCI) manufacturing site from the BLA. What do they have to do to accomplish this?
 
FDA: Send in an amendment with this request.
 
SLCBB: Will they need to resubmit all the information related to the SLCI manufacturing site in the future when they wish to add the site back?
 
FDA: Probably.  We suggest further discussion of this topic closer to when you plan to submit a BLA supplement for the SLCI site. 
 
FDA: Will the removal of the SLCI manufacturing site from the BLA affect the storage and tracking of the SLCBB manufactured CBUs? If yes, then some description of the segregation process, whether a physical or by record system, proposed for IND and BLA units will be needed.
 
FDA: When will ISBT 128 be implemented?
 
SLCBB: We have the equipment needed and expect to implement ISBT 128 in approximately four months. Do we have to use NDC compliant labels until then?
 
FDA: For licensure, either a NDC number or ISBT128 code will be needed.
 
SLCBB: Will the expiration date need to go on the label?
 
FDA: An expiration date is part of a full package label. However, we are not prepared to provide specific comments on this call about the cryobag label. We have been waiting to learn whether and when you plan to implement ISBT128 and submit a revised cryobag label.
 
FDA: When do you plan to send in responses to the 483 observations?
 
SLCBB: Collection, process, and media fill validation plans will be submitted soon followed by data. Reponses to other comments are being worked on.   Can we submit a partial response?
 
FDA: All questions should be answered. The answer can be an update on what is being done and when a complete response to the question will be submitted. Please apply for categorical assessment from environmental assessment.
 
SLCBB: Will do.