
 
  


Telecon, July 1, 2011 - Gintuit




  
 

Subject:                                    Telecon Memo

Date:                                        July 1, 2011, 9:00 AM

Phone No.:                               1-866-951-1151

FDA Participants:                     Gang Wang, Qiao Bobo

Organogenesis Participants:       Kristine Riley, Soraya Landers, and others

 

DMPQ initiated a telecon with the sponsor to clarify some review issues related 
to the facility, equipment and qualification/validation deficiencies identified 
in their BLA STN 125400/0. We told the sponsor that the relevant information 
listed below was not submitted, which was considered a significant deficiency, 
and wanted to verify whether or not they have performed the 
qualification/validation studies and have the relevant documents. The sponsor 
confirmed that they have performed the qualification/validation studies and have 
the requested information but have not submitted in the BLA. We told the firm 
that we will send them a formal Information Request in the next few days and 
they will need to submit the requested information in a specified time. The 
sponsor agreed to submit the information or will direct us on where we can 
locate the information in the BLA.

 

We also informed the sponsor that CBER will be conducting a pre-licensure 
inspection of their manufacturing facility in late summer or early fall and will 
be discussing with the sponsor on the inspectional issues at a later time.

 

We went through the following items with the sponsor and were told that they 
have the relevant information and will submit the information to CBER.

 

1.      The facility is a multi-product facility. No protocols (such as 
changeover and line clearance) and detailed descriptions on preventing 
contamination/cross-contamination and mix-up were submitted.

2.      No data, protocol # and summary on cleanroom qualifications were 
submitted.

3.      No data, protocol # and summary on cleaning and sanitization of the 
cleanroom and equipment were submitted.

4.      No data, protocol # and summary on utility systems, including water, 
steam, LN2, CO2, BMS, and computer system, were submitted.

5.      No data, protocol # and summary on HVAC system were submitted.

6.      No data, protocols and summary on EM were submitted.

7.      No data, protocol # and summary on manufacturing and QC equipment 
qualifications were submitted.

8.      Lack of detailed list of equipment, including single used and reusable, 
for manufacturing and QC test.

9.      No data, protocol # and summary on qualification of autoclave and        
                 ---b(4)-------------- were submitted.

10. No information on aseptic process validation was mentioned. Don’t if they 
didn’t do or didn’t submit.
 

   
 
