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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Letter, May 19 2011 - Kedbumin

Our STN:  BL 125384/0

Kedrion, S.p.A.
Attention:  Mr. Urs E. Aeberli
FFF Enterprises, Inc.
May 19, 2011
Sent by email: uaeberli@fffenterprises.com

Dear Me. Aeberli:

We are reviewing your August 2, 2010 submission to your original BLA for Albumin (Human).  We determined that the following information is necessary to continue our review

  1. For the (b)(4) test you should be reporting data from the beginning, middle and end and the unit on the value for the specification should be ----(b)(4)----.
  2. You still do not indicate the number of rejected lots, even though you should have done the final visual inspection before sending the lot release to us.
  3. After these last changes, please send the originally signed protocols along with the requested number of samples to the Sample Custodian.
  4. Please submit a blank protocol template, i.e. without actual data, to the file for the record.

The review of this submission is on-going and issues may be added, expanded upon, or modified as we continue to review this submission. If we determine that your response to this information request constitutes a major amendment, we will notify you in writing.

Please submit your response to this information request as an amendment to this file by May 23, 2011.  If you anticipate you will not be able to respond by this date, please contact the Agency immediately so a new response date can be identified.  The action due date for this file is June 3, 2011.

If you have any questions, please contact me at (301) 827-3927.

Sincerely,

Crystal Allard
Regulatory Project Manager
FDA/CBER/OBRR/DBA/RPMB