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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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
(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

Mark A. Shields
Regulatory Project Manager
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