
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 

 

Reviewers 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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