Telecon with Fresenius Kabi
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,
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