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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Final Review Memo (12/16/2008) - RiaSTAP

MEMORANDUM

DATEDecember 16, 2008
FROM

Christine Drabick, Bioresearch Monitoring Branch, HFM-664
Division of Inspections and Surveillance
Office of Compliance and Biologics Quality

THROUGH

Patricia Holobaugh, Bioresearch Monitoring Branch Chief, HFM-664

TO

Laura Wood, HFM-340, Chair, BLA Committee
Vasantha Kumar, HFM- 380, RPM, BLA Committee

SUBJECT

Bioresearch Monitoring Bioresearch Monitoring Inspection Results
SPONSOR: CSL Behring GmbH
PRODUCT: Human fibrinogen concentrate, pasteurized, Riastap ™
BLA: STN 125317/0

SUMMARY STATEMENT:

The bioresearch monitoring inspections of three clinical sites did not reveal problems that impact the data submitted in the application.

BACKGROUND:

Three clinical investigator inspections were performed in support of this Biologics License Application (BLA). Information from the BLA was compared to source documents during the inspections.

CLINICAL INVESTIGATORS:

 Site ## Subjects483?Inspection
Classification
New York Presbyterian Hospital
New York, New York
 
12
1
No
NAI
Children’s Memorial Hospital
Chicago, Illinois
 
15
1
No
NAI
Maine Hemophilia and
Thrombosis Center
Scarborough , Maine
 
19
1
No
NAI

STUDY TITLE: Pharmacokinetics of Haemocomplettan ® P in Subjects with Congenital Fibrinogen Deficiency (Study No. BI3023_2001)

SPONSOR ISSUES:

At two of the three inspected sites, the amount of study drug remaining after administration to Subject -(b)(6)- (42 ml) and Subject -(b)(6)- (25 ml) exceeded the expected amount. Both sites state the dose administered to the subjects was correct and the study drug was prepared according to the protocol. Clarification from the sponsor regarding this finding may be required.

NOTE WORTHY INSPECTIONAL FINDINGS:

The following required laboratory evaluations were not completed for Subject -(b)(6)-: One-hour post infusion Gamma-glutamyl transpeptidase (GGT), Day 2 GGT, Pre-infusion Platelets, and Day 5 Biochemistry.

BIMO ADMINISTRATIVE FOLLOW-UP:

Close out letters have been issued to the clinical investigators at the three inspected sites. Should you have any questions or comments about the contents of this memo or any aspect of Bioresearch Monitoring, please contact me at 301-827-6323.

_________________________________________
Christine J. Drabick, MS
Consumer Safety Officer

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