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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recommend Approval - Memo, October 10, 2009 - Berinert

To:Administrative File: Submission Tracking Number (STN) -
BL 125287, C1 Esterase Inhibitor (Human)
CSL Behring GmbH
Lic. # 1765, BLA
From:David Doleski, Team Leader, CBER/OCBQ/DMPQ/MRB2, HFM-676
Through:Chiang Syin, Ph.D., Chief, CBER/OCBQ/DMPQ/MRB2
Subject:Recommend Approval: This is BLA for C1 Esterase Inhibitor (Human).
Action Due Date:October 10, 2009


Based on the resolution of previously outstanding inspections issues, I recommend approval of this BLA.  All review issues are acceptable.

Review Details:

A pre-approval inspection was conducted of this firm from May 26 to June 3, 2008.  The CBER inspection team consisted of myself, Felice D'Agnillo, and Marion Michaelis.  Please see the EIR for more details. 

At the time that a Complete Response letter was issued (December 5, 2008), there were still outstanding inspection issues.  I had drafted a memo dated November 25, 2008 recommending issuance of a CR letter due to these outstanding inspection issues. Since that time, the inspection issues have been resolved. 

At the time that the CR letter issued in December 2008, all DMPQ review issues regarding the facilities, manufacturing or equipment or any other matter within our purview had already been resolved.