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Vaccines, Blood & Biologics

Record of Telephone Conversation, November 28, 2012 - HPC, Cord Blood BLA 125432


HPC, Cord Blood
LifeSouth Community Blood Centers, Inc.
Telecon Date/Time: 28-Nov-2012 11:00 PM        Initiated by FDA? Yes
Telephone Number: -----------(b)(4)-------------------------------
Communication Categorie(s):
1. Inspection Related
2. Advice
3. Information Request
Telecon Summary:
FDA requested t-con to discuss sterility validation; their proposed timelines; and 483 inpsectional responses.
FDA Participants: Mohammad Heidaran, Ph.D., Biologist (CBER/OCTGT/DCGT)
      Eric Dollins, Ph.D., Biologist (CBER/OCTGT/DCGT)
      Joydeep Ghosh, Ph.D., Microbiologist (CBER/OCTGT/DCGT)
      Kimberly Benton, Ph.D., Deputy Director (CBER/OCTGT/DCGT)
      Marion Michaelis, Team Leader (CBER/OCBQ/DMPQ)
                              Candace Jarvis, B.S., CSO (CBER/OCTGT/RMS)
Non-FDA Participants: Lori Masingil (Technical Communications Manager)
                                     Tammy Lawson, (Validation Coordinator)
                                     Amy Lambert, (Manager Cellular Therapies)
 Ed Downey, (Administrative Laboratory Manager)
 Evan Basler
 Louis Hernandez
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Telecon Body:
 FDA requested a teleconference with LifeSouth to discuss their proposed timelines that were sent by Ms Jill Evans on 11/19/12, the timing of their sterility validation plan and their responses to outstanding 483 inspectional findings.
FDA requested LifeSouth to provide a timeline for the submission of their validation protocols for review. FDA also noted that for comment purposes only; that they did not need to submit the protocols formally until they were completed. LifeSouth stated that it was their goal to submit the protocols with in the next two weeks at the max; however, they would try to get it sooner, they just wanted to wait until the completion of their clean room renovation. 
Next, FDA asked if it was their plan to exclude donor moms who are on antibiotics. LifeSouth stated that donor moms would be excluded; however they may want to include them at a later date. 
FDA asked if LifeSouth is planning to adhere to the January 24th date and that if they submitted anything beyond the end of January, beginning of February timeframe, then there would not be enough time to review the information. FDA also stated that this time is critical for review and that they need to prepare to make a decision on how to proceed with the information given. The options moving forward would be to extend the review clock by 3 months and/or issue a Complete Response (CR letter). FDA reiterated that no decision has been made and that it is in the best interest that they stick to their proposed time lines.   LifeSouth stated that it is their plan to stick with the timelines proposed and that they would keep FDA apprised of any changes.
LifeSouth should provide the following for updates to 483 Observations (inspectional issues):
Observation 1: Batch Production and Control Record
Batch Records are okay to submit formally
Observation 2 &16 QC Record Review/Responsibilities of the Quality Unit (QU)
FDA asked LS to provide an update on SOP revision for over-arching QU SOP
Observation 3: Timeframe for the addition of DMSO
FDA asked LS to provide timeframe for submission
Observation 4: Growth Promotion Testing/Growth Media
FDA conducted a telecon on 11/27 with LifeSouth (See EDR) to review the latest protocol. LS should submit a revised protocol for review.
Observation 5d
LS should provide an update on their final plans for monitoring room pressure.
Observation 6 Training
LS should provide an update on in-house training program that will be implemented for training personnel for GMP manufacturing practices in a cleanroom
Observation 7a, b and c
LS should provide an update on cleanroom qualification under dynamic conditions (7a). For b and c the firm should provide an update on what the final decision was for the window and flooring.
LS responded that the clean room is under construction and they are putting in an audible alarm to monitor the pressure and they also will have electronic monitoring. FDA asked that they submit a short summary of this.
Observation 8a & 8c: Environmental Monitoring
FDA asked LS to provide status update on room and equipment qualification.
Observation 9: Investigations
FDA asked LS to provide update on SOP status.
Observation 10: Written Procedures
FDA asked LS to provide update on written procedures
Observation 12: Laboratory
FDA asked LS to provide update on SOP status.
Observation 13a & 13c; Adverse Events and Complaints
FDA asked LS to provide update on SOP status.
Observation 16: QC Record Review/Responsibilities of the QC Unit
Covered under Quality Unit oversight
Observation 18: Pest Control.
FDA asked LS to provide an update on how the plan to control pest inside the facility.
FDA noted that for any observations not mention in the above list the initial responses provided were satisfactory. Life South agreed to provide the requested information.
FDA indicated to LifeSouth to send in separate amendments for review issue information and inspection related information
The call ended cordially.

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