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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Telecon, October 7, 2011 - Hemacord

 

Date/Time of Call:                              October 7, 2011 @ 2:30 P.M.  
 
CBER Representative:                     Mohammad Heidaran, Biologist, CBER/DMPQ
                                                            Laurie Norwood, Deputy Director, DMPQ
                                                            John Eltermann, Director, DMPQ
                                                            Chiang Syin, Branch Chief, DMPQ
                       
Organization Representative:           Eva Quinley
                                                            Andromachi Scaradavou
                                                            Michael Tarnawski
                                                            Pablo Rubenstein
                                                            Michael Zdanowski
 
Organization:                                      New York Blood Center Inc.
 
Subject:                                               Retention Sample, Batch Record, BSC Monitoring  
 
STN:                                                   125397/0
                       
 
The following outstanding deficiencies were discussed:
 
  • We mentioned to NYBC that retention sample is a regulatory requirement
  • Since DMSO is ---(b)(4)--- added to the final product, the BSC, where the DMSO addition is performed, should be monitored according to (b)(4) classification. 
  • We pointed out that the Batch record was deficient as it did not contain detailed information about critical steps of manufacturing process.
 
NYBC agreed to monitor BSC according to (b)(4) classification. In addition they agreed to retain a sample of the UCB and to provide FDA with a proposal on how to do so. We also agreed to have further discussion to revise the batch record on Wednesday October 12th.