Vaccines, Blood & Biologics
Telecon with Fresenius Kabi - 10/31/2007
Telecon with Fresenius Kabi
|Meeting called by:||Franklin. Stephenson/ RPM|
|Type of meeting:||Telecon
|FDA Participants:||Franklin Stephenson, Dr. Lawrence Landow|
|Baxter Participants:||Dr. Jungheinrich, Mr Coln|
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