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Vaccines, Blood & Biologics

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Vaccines

Email - Compliance Check, February 17, 2011 - Adenovirus

From: CBER Complicheck
Sent: Thursday, February 17, 2011 11:10 AM
To: Wang, Gang
Cc: CBER Complicheck
Subject: STUN 125296/0

Applicant:    

Teva Women's Health, Inc., 425 Privet Road, Horsham, PA, 19044-8005

Manufacturing Location:

Barr Laboratories, Inc. (division of Teva) 2150 Perrowville Rd, Forest, VA 24551-4129 
FEI #: 3000718267

STN 125296/0

Summary: For manufacturing of Adenovirus Type 4 and Type 7 Vaccine, Live, Oral, indicated for active immunization for the prevention of febrile acute respiratory disease caused by adenovirus Type 4 and Type 7 in military populations 17 through (b)(4) years of age.

A Prelicense inspection (PLI) of Barr Laboratories, Inc. (division of Teva) located at 2150 Perrowville Rd, Forest, VA 24551-4129 (FEI #: 3000718267), was conducted April 20-24, 2009 and classified as Voluntary Action Indicated (VAI).  The inspection was endorsed as approvable on December 10, 2010.  Therefore, the Office of Compliance and Biologics Quality, Division of Case Management does not object to the approval of this supplement.

Marc A. Alston, CSO
CBER/OCBQ/DCM/HFM-624
_____________________________________________
From:                     Wang, Gang 
Sent:                      Wednesday, February 16, 2011 2:37 PM
To:                          CBER Complicheck
Subject:                 Compliance Check request for Barr Laboratories

COMPLIANCE CHECK

Request Type: 

Original

Application Number or Supplement Number and Type

BLA STN 125296/0

Product:

Adenovirus Type 4 and Type 7 Vaccine, Live, Oral

Applicant:                              

Teva Women's Health, Inc., 425 Privet Road, Horsham, PA, 19044-8005

Manufacturing Location:

Barr Laboratories, Inc. (division of Teva) 2150 Perrowville Rd, Forest, VA 24551-4129 

US License Number

1804

FEI No:

3000718267

Short Summary:

For manufacturing of Adenovirus Type 4 and Type 7 Vaccine, Live, Oral, indicated for active immunization for the prevention of febrile acute respiratory disease caused by adenovirus Type 4 and Type 7 in military populations 17 through (b)(4) years of age.

 

Gang Wang, Ph.D.
Expert Biologist
FDA/CBER/OCBQ/DMPQ
Phone:  301-827-3010
Fax:    301-827-3536
Email:  gang.wang@fda.hhs.gov