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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Memo - Teleconference with CSLB Marburg, Germany, January 18, 2011 - Corifact

Date:      January 18, 2011

To:         CSLB BLA for Factor XIII 1256385.0

From:      CAPT Martha O’Lone, BSN, MRBI/DMPQ/OCBQ/CBER

Subject:  Teleconference with CSLB Marburg, Germany  January 14-18, 2011

Participants
GSK
Anne- Regine Herboth, CSLB Marburg, Regulatory Affairs
FDA
CAPT Martha O’Lone, FDA/ CBER/ DMPQI

CSLB was contacted initially on January 14, 2011 to discuss the -------------(b)(4)-------- acceptance criteria and to request additional information about the container closure integrity test method for the 30 ml vials used for Factor XIII.  After discussion with Ms. Herboth in Germany subsequent discussion of these items was conducted by email and or telephone through January 18, 2011.

---------------(b)(4)--------------
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.

Container Closure Integrity Testing for the 30 ml vial
The second issue discussed during the telephone call and in subsequent emails and calls until January 18, 2011 was that the sensitivity of CSLB’s container closure integrity test method did not detect particles smaller than ---(b)(4)---. This issue had been discussed with CSLB Marburg for other products during the review of this file. Since the testing was not correlated to the size ----------------------------(b)(4)-----------------------------------------.  CSLB was contacted during this review and provided --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.