
 
  


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

 

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