• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

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

THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please immediately notify the sender immediately by e-mail at randa.melhem@fda.hhs.gov or phone.