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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Closeout Memo - Flublok


Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Manufacturing and Product Quality
To:                  File STN 125285/0
From:             Deborah Trout, Committee Member, OCBQ/DMPQ, HFM-675
Subject:          Attachment of Jonathan McInnis, OCBQ, DMPQ review memo

Jonathan McInnis, OCBQ, DMPQ has left the Agency and his review memo was not signed or reviewed prior to his departure. I have attached Mr. McInnis review memo (received vial email on August 22, 2008) in its original form to close out the administrative file. The issues noted for a Complete Response letter were addressed in Protein Science’s response to the FDA from 483 to the July 2008 inspection. These items were ultimately resolved during the follow-up inspections