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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Telecon with Fresenius Kabi - 10/31/2007

Telecon with Fresenius Kabi

31-Oct- 2007
RE: BN070012

Meeting called by: Franklin. Stephenson/ RPM
 
Type of meeting: Telecon
919-881-9900
FDA Participants: Franklin Stephenson, Dr. Lawrence Landow
Baxter Participants: Dr. Jungheinrich, Mr Coln

Agenda

Conversation Record:

  • We contacted Dr. Jungheinrich and Mr. Coln and requested that the following documents be submitted to the file in the form of an amendment:

     

    • The batch protocols of 3 consecutives stability batches with English translation.
    • A flow chart indicating the differences in production of these batches compared to the full-scale production batches.

     

  • The sponsor stated that they would comply within the next couple of weeks.

     

Franklin T. Stephenson
Regulatory Project Manager
OBRR/DBA