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Vaccines, Blood & Biologics

Record of Telephone Conversation, September 13, 2012 - HPC, Cord Blood BLA 125432


Submission Type: BLA    Submission ID: 125432/0    Office: OCTGT
HPC, Cord Blood
LifeSouth Community Blood Centers, Inc.
Telecon Date/Time: 13-Sep-2012 12:30 PM        Initiated by FDA? Yes
Telephone Number: -------------------
Communication Categorie(s):
1. Advice/information Request
Telecon Summary:
Sponsor requested brief t-con to discuss inspection related details for the 9/24-28th site inspection
FDA Participants: Grace M.B. Deneke, CSO (CBER/OCBQ/DMPQ)
       Marion Michaelis, Team Leader (CBER/OCBQ/DMPQ)
      Candace Jarvis, RPM (CBER/OCTGT)
Non-FDA Participants: Kathleen Sazama (Medical Officer)
   Jill Evans, Vice President of Quality
   Amy Lambert
Telecon Body:
Life South requested a brief teleconference with the agency to discuss the format/logistics for the pending September 2012 site inspection (i.e., war room, conference space set-up, etc.)
Life South confirmed that that they were able to secure their largest conference room for four out of the five inspection days and suggested if on Tuesday, September 25th FDA would consider inspecting the lab and/or hospital where CB is tested and collected. FDA responded that as discussed before, they would still need lots of space to review documents and perform individual interviews for all five days. Life South informed FDA that due to prior scheduled activities in that room they would have to provide an alternate space. FDA agreed and emphasized that the room or rooms should be set up prior to their arrival. The sponsor agreed with this request and asked if the FDA schedule time for the inspection was from 8:30am to 5:00pm. FDA responded that their arrival time would be at 8:30 am on Monday but the rest of the week could change depending on the production schedule and stated  that there is no way of knowing what time the inspection would finish, therefore suggested that the sponsor have individuals available to accommodate the times that they are there.
Further, the sponsor noted that it would be difficult to assign an individual person to each FDA staff member and if they had any suggestions on how they would like to be accommodated. FDA stated that the sponsor would need subject matter experts with dual responsibilities to provide technical support and documentation support as needed. FDA also suggested that they utilize scribes. Life South agreed to this suggestion.
The sponsor asked FDA if they needed to go to the collection site. FDA responded that it was not necessary, but if additional information is needed about the collection site, it will have to be provided.
Furthermore, the sponsor asked if FDA will have special reviewers assigned to specific areas. FDA explained that there will be two product reviewers that will review product related information as well as safety of adverse events, two facility reviewers will cover facilities and related areas, and one team biologics reviewer will cover all areas of cGMP.
FDA asked when the sponsor would be able to provide the pre-request information. The sponsor stated by Wednesday, September 19, 2012. FDA stated that would be acceptable and emphasized that the information should include the production and release testing schedule. The sponsor stated that would also be sent.
The call ended cordially.

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