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Vaccines, Blood & Biologics

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

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

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

Thank you,


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

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