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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request - EVARREST, January 5, 2011

Melhem, Randa



 

From: Melhem, Randa
Sent: Wednesday, January 05, 2011 11:34 AM
To: 'Sara Horn'
Cc: Shields, Mark; Kelly, Sonday
Subject: RE: Information Request BLA STN 125392/0



 

Dear Dr. Horn,

In the BLA submission for the Fibrin Pad, Omrix provided information about b(4) facilities that are involved in the Fibrin pad manufacturing process

----b(4)--------------------------------------------------------------------------------------------------------------------------------
Omrix Biopharmaceuticals Ltd. FPPF (FDA Registration # not provided)
----b(4)------------------------------------------------

1. Please provide the FDA Registration number for Omrix FPPF.
2. Please provide the FDA Inspection history for the Omrix Facilities.

Thank you,

Randa

Randa Melhem, Ph.D. Consumer Safety Officer FDA/CBER/OCBQ/DMPQ
Phone: 301-827-6999 Fax 301-827-3536

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