• 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 Memo - EVARREST, May 5, 2011

Our Reference: BL125392/0

Omrix Biopharmaceuticals, Inc.
Attention: ----(b)(4)----
May 5, 2011
Sent by FAX: ----(b)(4)----

Dear ---(b)(4)---:

We are reviewing your November 19, 2010 biologics license application (BLA) for Fibrin Pad. We determined that the following information is necessary to continue our review:

Shipping Validation

  1. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.
  2. -------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)-------------------------------------------------------------------------------------------------------------------------------------------------.
  3. -------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.
  4. -------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)----------------------------- ----------------------------------------------------------------.

Container Closure

5. -------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.

1 page redacted (b)(4)

    1. -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)---------------------------------------------------------------------------------------------------------------------------------------------.
    2. ------------------------------------------------------------------------------(b)(4)------------------------------------.
    3. --------------------------------------------------------------------------------------------------------------------------(b)(4)---------------------------------------------------------------------------------------------------------------------------------------------.
    4. ------------------------------------------------------------------------------(b)(4)-----------------------------------------------------------------------------------------------.

---------------(b)(4)-----------------

  1. ------------------------------------------------------------------------------------------------------------------------(b)(4)-------------------------------------------------------------------------------------------------------------
    1. -----------------------------------------------------------------------------------------------(b)(4)-----------------------------------------------------------------------------------.
    2. -----------------------------------------------------------------------------------------------(b)(4)------------------------------------------------------
    3. ----------------------------------------------------------------------------(b)(4)-----------------------------------------------------
  2. The qualification of the e-beam sterilization of the Fibrin Pad was performed on the ----(b)(4)----. Please provide the e-beam sterilization qualification for the Fibrin Pad using the ---------(b)(4)----------. If this qualification was not performed, please provide the rationale for not performing the qualification on the -----------(b)(4)---------------- process.


The review of this submission is on-going and issues may be added, expanded upon, or modified as we continue to review this submission.

Please submit your response to this information request as an amendment to this file referencing the date of this request.

If we determine that your response to this information request constitutes a major amendment, we will notify you in writing.

The action due date for this file is September 19, 2011.

If you have any questions, please contact me at (301) 827-6122.

Sincerely,

 

Sonday L. Kelly
Regulatory Project Manager
FDA/CBER/OBRR/DBA/RPMB