OBRR Lot Release Clearance Memo Email, June 3, 2011 - Kedbumin

From:                     CBER Lot Clearance

Sent:                      Friday, June 03, 2011 2:35 PM

To:                         Shields, Mark; CBER Lot Clearance

Cc:                         Allard, Crystal

Subject:                 RE: OBRR Lot release clearance memo: STN:125384/0 :Kedrion, S.p.A. ADD: 03-Jun-2011

A review of PRB records indicates that there are no pending lots or issues that would affect approval of the stated STN.

 

Thank you,

Joseph Quander III
Chief, Product Release Branch
CBER/OCBQ/DMPQ
(301) 594-6517; (301) 594-6924 (Fax)

 

_____________________________________________
From: Shields, Mark 
Sent: Friday, June 03, 2011 2:33 PM
To: CBER Lot Clearance
Cc: Allard, Crystal; Quander III, Joseph
Subject: OBRR Lot release clearance memo: STN:125384/0 :Kedrion, S.p.A. ADD: 03-Jun-2011

 

Please confirm that there are no lots associated with this Application.

 

STN_ No: 125384/0

Lic. #:         1851                             Company: Kedrion, S.p.A..



Product: Albumin (Human)

 

Subm Type:Supplement                      Subtype: Original Application

 

Action Due Date: 03-Jun-2011

 

Short Summary: Original Application for 25% Albumin (human) solution

 

Thanks!

 

Mark A. Shields 
Regulatory Project Manager 
HFM-380  FDA/CBER 
Office of Blood Research and Review 
Division of Blood Applications 
301-827-6173 fax 301-827-2405 
email: mark.shields@fda.hhs.gov 
1401 Rockville Pike 
Rockville, MD 20852-1448
