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

 
 
 

Product:

HPC, Cord Blood

Applicant:

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

 

Author: CANDACE JARVIS

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.

Sterility:

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 FDA also noted that for comment purposes only; that they did not need to submit the protocols formally until they were completed.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. 

Timelines:

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.