
Telecon with Fresenius Kabi - 10/31/2007 - Voluven


 

 
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
