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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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.