
Closeout Memo - Flublok

 
 

Memorandum 

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

                                                                                                                       

Comments

 

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
