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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Compliance Check Email, May 29, 2012 - MenHibrix

From:                     CBER Complicheck
Sent:                      Tuesday, May 29, 2012 1:44 PM
To:                         Byrd, Sean (CBER)
Cc:                         CBER Complicheck
Subject:                 RE: Compliance Check, MenHibrix, STN 125363/0

Importance:            High
Company/Address:
GlaxoSmithKline Biologicals S.A.
2301 Renaissance Blvd., Building 510
P.O. Box 61540
King of Prussia, PA  19406-2772
Lic. #: 1617                           

Manufacturing locations:
GlaxoSmithKline Biologicals, S. A. d/b/a GlaxoSmithKline
Rue de l'Institut 89
B-1330 Rixensart
BELGIUM

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STN:   125363/0

Short Summary: 
active immunization of infants and toddlers 6 weeks through 15 months of age for the prevention of invasive diseases caused by Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y

A Pre-License Inspection (PLI) of GlaxoSmithKline Biologicals Kft located at ---b(4)--------------------------------------------------- was conducted March 4 through March 12, 2010 and classified as Voluntary Action Indicated (VAI).  The closeout memo was dated May 21, 2012.  There are no ongoing or pending investigations or compliance actions with respect to the above facility or its product(s). Therefore, the Office of Compliance and Biologics Quality, Division of Case Management does not object to the approval of this supplement.
Shannon Aldrich, CSO
CBER/OCBQ/DCM/HFM-610
_____________________________________________
From:                     Byrd, Sean (CBER) 
Sent:                      Tuesday, May 22, 2012 9:58 AM
To:                          CBER Complicheck
Cc:                          Staten, David; Temenak, Joseph; Prutzman, Kirk C; Renshaw, Carolyn
Subject:                Compliance Check, MenHibrix, STN 125363/0
Importance:        High

 

Manufacturing locations:
GlaxoSmithKline Biologicals, S. A. d/b/a GlaxoSmithKline
Rue de l'Institut 89
B-1330 Rixensart
BELGIUM
(Drug substance and drug product manufacturer)

 

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STN:   125363/0

Lic. #: 1617                           

Company/Address:
GlaxoSmithKline Biologicals S.A.
2301 Renaissance Blvd., Building 510
P.O. Box 61540
King of Prussia, PA  19406-2772
(U.S. representative)

Product: meningococcal and Hib TT conjugate vaccine

Subm Type:   BLA               

First Action Due Date: 31 August 2012 (NOTE:  Internal MANDATORY action due date is 15 June 2012)

Short Summary: 
active immunization of infants and toddlers 6 weeks through 15 months of age for the prevention of invasive diseases caused by Haemophilus influenzae type b
and Neisseria meningitidis serogroups C and Y

Sean R. Byrd
Lieutenant Commander, USPHS
Director, Regulatory Review Officer
CBER/OCBQ/DMPQ
Office: 301-827-6951
Fax:  301-827-3536