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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Bioresearch Monitoring Inspection Results - August 20, 2009

 M E M O R A N D U M 

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration 
Center for Biologics Evaluation and Research


 

DATE  August 20, 2009
FROM

 Anthony Hawkins, Bioresearch Monitoring, HFM-664

Division of Inspections and Surveillance
Office of Compliance and Biologics Quality

THROUGHPatricia Holobaugh, Bioresearch Monitoring Branch Chief, HFM-664
TO    
SUBJECT 

SUMMARY STATEMENT

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

BACKGROUND

There were four clinical investigator inspections performed in support of this Biologics License Application (BLA).  Study subject population, geographic distribution and field resource considerations were among the factors used to select the inspected sites.  Information from the BLA was compared to source documents, during the inspections. 

CLINICAL INVESTIGATOR SITES

                                                                                                                                 

  Site #   #Subjects  483?   Inspection
Classification
Buffalo, New York  001                               5                         Yes                 VAI
 005                        12                        Yes                 VAI
Seattle, Washington  006                          7                         Yes                 VAI
Irving, Texas 010                         7                         Yes                 VAI

STUDY TITLE:

A Phase III, Multicenter, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Gammaplex® in Primary Immunodeficiency Diseases

(Protocol GMX01)

SPONSOR ISSUES             

We did not note any sponsor or monitoring issues.   

NOTEWORTHY INSPECTIONAL FINDINGS

There were a few minor problems noted.  The clinical investigator administered Gammaplex to five subjects on more than 20 occasions using a 180 micron filter instead of the protocol required 15-20 micron filter; the site discontinued the 180 micron filter after receipt of a sponsor notification regarding acceptable product administration sets including proper filter size, four months after the initial treatment of subjects. (Site 001)  Six subjects received a total of more than two dozen Gammaplex infusions without using any administration filter including the protocol required 15 to 20 micron filter. (Site 010)  Five subjects received 39 total infusions of Gammaplex at dosage levels that were different from the same dosage used previously to establish steady state, as required by the protocol.  The clinical investigator did not report one serious adverse event (uterine bleeding and hospitalization) to the sponsor or the IRB, as required by the protocol. (Site 005)  More than a dozen Gammaplex infusions took place later than the protocol-specified start time limit (range: 15 minutes to 1 hour 20 minutes late).  Subject vital signs were not always obtained using the same body position, as required by the protocol. (Site 006)  The clinical investigator enrolled three subjects who did not meet all the inclusion and exclusion criteria including time interval for prior receipt of licensed or investigational IGIV replacement therapy.  There were study drug accountability discrepancies including Gammaplexreceipt, destruction and dispensing for treatment of subjects; the study monitor noted no such accountability discrepancies. (Site 010)

BIMO ADMINISTRATIVE FOLLOW-UP

We issued inspection closeout letters to the clinical investigators at sites 001, 005, 006 and 010.  Please contact me at (301) 827-6338 if you have any questions about this memo or any aspect of bioresearch monitoring.

_______________________

Anthony Hawkins
Consumer Safety Officer