Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Vaccines, Blood & Biologics

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,


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

Page Last Updated: 02/21/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English