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Vaccines

Record of Telephone Conversation, November 30, 2012pm - Q-Pan


Submission Type: BLA    Submission ID: 125419/0    Office: OVRR

Product:
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

Applicant:
ID Biomedical Corporation of Quebec (dba GlaxoSmithKline Biologicals)

Telecon Date/Time: 30-Nov-2012 01:30 PM        Initiated by FDA? Yes

Telephone Number: 610-787-3435

Communication Categorie(s):

1.  Information Request

Author: CARMEN M. COLLAZO-CUSTODIO

Telecon Summary:
Follow-up discussion regarding the telephone conversation held on November 29, 2012, in which CBER requested clarification on discrepancies found on environmental monitoring qualification studies performed at the Rixensart facility.

FDA Participants: Carmen M. Collazo-Custodio, Randa Melhem

Non-FDA Participants: Michael Schwartz

Telecon Body:
This was a follow-up discussion regarding the telephone conversation held on November 29, 2012, in which CBER requested clarification on discrepancies found on environmental monitoring qualification studies performed at the Rixensart facility.  The reports were:

RX20070040, Environment qualification of the (b)(4), rooms ------------------------------------------------------------------------------(b)(4)---------------------------------------------------------------

RX20070673, Intensive environmental monitoring Building --(b)(4)--- - Filling Unit - -(b)(4) - Room ---(b)(4)-----
 
RX20070513, Environment qualification of the room ----(b)(4)----- Building (b)(4) - Filling Facility 

CBER identified discrepancies in the dates provided in those reports.  Furthermore, in some cases it appeared that data were missing in the final reports.  Dr. Schwartz contacted his colleagues in Belgium and provided feedback to CBER.  The feedback received was that, indeed, there were several errors in those reports, including date discrepancies and missing data.  It was agreed to arrange a telephone conversation with GSK representatives from Belgium to discuss this matter.