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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Summary of Telecon, February 13, 2012 - Gintuit

 

From:                     Bobo, Qiao
Sent:                      Monday, February 13, 2012 3:56 PM
To:                         Kristine Riley
Cc:                         Lee, Mark H (FDA); Thomas, Terrolyn
Subject:                 125400/0-Summary of Telecon 13 Feb 2012
 
Dear Ms. Riley,
 
I reviewed your response submitted on 10 February 2012 to our 26 January 2012 DMPQ information request. Below is a summary of our telecon today for additional questions.
 
(1) Regarding your response to Question 1c in 26 January 2012 information request, you stated that "Organogenesis will develop and execute a protocol to demonstrate microorganism growth under the same condition as the ---b(4)---------------------------------------------------. This study will be conducted post approval." We suggest you conduct the study before the BLA approval.
 
(2) Regarding your response to Question 2, it seems no visual inspection or routine monitoring is performed for your ----b(4)----------------------------------------. What is the cleaning procedure and what is the preventative and maintenance program and record for –b(4)-----------. How do you ensure that there is no breakdown of interior, no microorganism growth or material build-up inside the –b(4)--------
 
(3) During the inspection conducted in October 3-7, Organogenesis committed to repeat the process simulation validation study following the corrected protocol because growth promotion study was omitted in the validation protocol during the first process simulation validation study. Please complete the study prior to BLA approval.
 
(4) Your glasswasher validation studies have -----b(4)-----------------------------------------------------------------------------. Please justify why the validation studies did not include both the testing of –b(4)- samples and –b(4)-- for each washer.
 
(5) Please provide a overview of your bioburden, BacT/ALERT and USP sterility tests in your in-process and final products. Please describe the different method used and the rationales for choosing different tests at different stages of process. Please specify the tests that are used for product release.
 
Regards,
 
Qiao Bobo, Ph.D., RAC
LCDR, USPHS, Regulatory Officer
Division of Manufacturing and Product Quality (DMPQ)
Office of Compliance and Biologics Quality (OCBQ)
Center for Biological Evaluation and Review (CBER)
Food and Drug Administration (FDA)
1401 Rockville Pike - HFM-676
Rockville, MD 20852-1448
Phone: (301) 827-3348
qiao.bobo@fda.hhs.gov
 
"Protecting, Promoting, and Advancing the Health and Safety of the Nation"
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