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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Establishment Evaluation Request, Bivigam

 

Applicant:
Biotest Pharmaceuticals Corporation
 
Corporate Address:
5800 park of Commerce Blvd., NW
Boca Raton, FL 33487
 
Manufacturing address:
5800 Park of Commerce Blvd., NW
Boca Raton, FL 33487
FEI# 1000525461
 
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Summary: Primary Immune Deficiency Disorders (PIDD) – Immune Globulin intravenous (Human)
 
A TBIO inspection of Biotest Pharmaceuticals Corporation facility located in 5800 Park of Commerce Blvd., NW Boca Raton, FL 33487 (FEI# 1000525461) was conduct May 9-17, 2012 and classified as Voluntary Action Indicated (VAI). An inspection waiver memo is dated December 14, 2012.  Therefore, the Office of Compliance and Biologics Quality, Division of Case Management does not object to the approval of this supplement.
 
Marc A. Alston, M.S. CSO
CBER/OCBQ/DCM/BDDCB/HFM-610
_____________________________________________
From:                    McGuire, Jeffrey 
Sent:                      Monday, December 17, 2012 3:49 PM
To:                         CBER Complicheck
Cc:                         Alston, Marc
Subject:                 Request for Compliance Check ACTION DUE 12/26/12
Importance:          High
 
ESTABLISHMENT EVALUATION REQUEST
 
Date:
 
December 17, 2012
 
Request Type (Check One):
Original  X       Follow-up
 
Reviewer’s Name, Division, Mail Code, Phone Number:
 
Destry Sillivan- OCBQ/DMPQ HFM-676 301-827-3031
 
Application Number and Type (BLA, PMA, NDA, ANDA) or Supplement Number and
Type (i.e., PAS, CBE, CBE30):
 
 Original BLA STN 125389/0
 
Brief Description of the Application or Detailed Summary of the Supplement, including
product(s) and establishment(s) (indicate if the supplement represents an improvement or
change intended to help the applicant or location achieve compliance):
                                                                                                               
Primary Immune Deficiency Disorders (PIDD) – Immune Globulin intravenous (Human)
 
Applicant:
Biotest Pharmaceuticals Corporation
 
Corporate Address:
5800 park of Commerce Blvd., NW
Boca Raton, FL 33487
 
Manufacturing address:
5800 Park of Commerce Blvd., NW
Boca Raton, FL 33487
 
FEI# 1000525461
 
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ADD:
December 26, 2012
 
U.S. License Number (if any):
1792
 
 << File: Biotest 125389-0 PLI Waiver Memo -DS (3).pdf >>
 
 
Jeffrey A. McGuire
Senior Regulatory Information Specialist
CBER/OCBQ/DMPQ
301-827-7096
 
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