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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Record of Telephone Conversation, February 11, 2011 - Corifact

Submission Type: BLA    Submission ID: 125385/0    Office: OBRR

Product:
Factor XIII Concentrate (Human)

Applicant:
CSL Behring GmbH

Telecon Date/Time: 11 February 2011, 10:20 AM        Initiated by FDA? Yes

Telephone Number: ---------(b)(6)----------

Communication Categorie(s):
1. Other - ------(b)(4)--------

Author: NANNETTE CAGUNGUN

Purpose of Telecon:
---------------------------------------------------------------------------(b)(4)----------------------------------------------------------------------------------------

FDA Participants: Nannette Cagungun and Tim Lee

CSL Behring Participants: David Desris and Anne Regine-Herboth

Trans-BLA Group: No

Related STNs: None
Related PMCs: None

Telecon Body:

Dr. Lee stated that the acceptance criterion for ------------(b)(4)---------, is not representative of CSLB’s manufacturing experience since the ------(b)(4)------ in all the reported lots are -----(b)(4)----.  Therefore, the current acceptance criterion is not acceptable.  Dr. Lee commented that the action limit for the ------(b)(4)------ should be set based on statistical analysis of the testing results generated from their (b)(4) Factor XIII lots.  Dr. Lee stated that FDA accepts acceptance criterion based on the mean + 3 standard deviations. 

Mr. Desris and Ms. Herboth informed us that they would not be able to provide us with the revised ---(b)(4)--- acceptance criterion until Monday, February 14, 2011.  Mr. Desris and Ms. Herboth stated that they will send the revised --------------(b)(4)--------------------- by email, which will be followed by an ESG submission.