
7-31-2007 Fax - RECOTHROM

 

 
FACSIMILE TRANSMISSION RECORD

Division of Blood Applications
 1401 Rockville Pike, Suite 400N, HFM-380
 Rockville, Maryland 20852-1448

FAX (301) 827-3534
 TEL (301) 827-6173

31-Jul-07

FAX No. 206-428-4030
To: Mark Gauthier, Regulatory Affairs
 This Fax is regarding STN 125248/0 that was submitted to the agency on 18-Dec-06, designated as a New BLA for manufacture of Thrombin (Recombinant).

The following comments are regarding the Lot Release Protocol.

Reviewers' Information Request

1.Page 1 issues

 
a.First line should read - cc: 125248-0/1758-FC
b.Under Reason for Submission, For Licensing Action - remove "/License # 1758. It is not needed.
c.Under the Fill Information before the Recommended Reconstitution Volume, please add the "Storage Conditions: -----ºC"

 


2.Page 2 Issues

 
a.First line should read - cc: 125248-0/1758-FC
b.Each sterility test should be displayed separately.



Information provided by: J. Quander III     Date: 31 Jun-07

Approved by R. Drews   Date 31-Jun-07   Transmitted by M. Shields   Date: 31Jun-07
