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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recommendation for Consideration for Licensure of Rotavirus Vaccine - Rotarix


Date: March 18, 2008
From: Inspectors: Pete Amin, CBER/OCBQ/DMPQ, HFM-676
Jonathan McInnis, CBER/OCBQ/DMPQ, HFM-676
Subject: Recommendation for consideration for licensure of Rotavirus Vaccine, STN 125265/0 is for manufacture, fill, and finishing at the -----------, Belgium, location.
To: Establishment Inspection File (EIF) for GlaxoSmith Kline Biologicals BLA File: STN BL 125265/0

We have reviewed and evaluated the January 15, 2008 responses from GSK Biologicals, which was in reply to the Form FDA-483 List of Observations dated December 13, 2007. The written statement of rationale to explain the observations noted during the pre-license inspection, appear to be adequate and complete. All corrective actions should be verified during the next routine GMP inspection of the firm.

Therefore, we recommend that the manufacture, fill and finishing sites in Buildings ----, ---- in ---------- and Building -- in Rixensart in ---------------, Belgium be approved as part of the license for Rotavirus Vaccine, STN 125265/0.

Pete Amin

Jonathan McInnis

Dino Feigelstock
Staff Fellow


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