Product Approval Information
September 23, 2008
U.S. License Number: 1798
Biotest Medical Diagnostics GmbH
Attention : Dr. Rolf Vornhagen
Industriestrasse 1
D-63303 Dreieich
GERMANY
Dear Dr. Vornhagen:
In our August 14, 2008 biologics license applications approval letter for the Blood Grouping Reagents and Anti-Human Globulin reagents using the tube test, the dating period for Blood Grouping Reagent Anti-e (Monoclonal) (Submission Tracking Number BL 125229/0) was stated to be 15 months from the date of manufacture and the date of manufacture was defined as the date of ----------.
Upon review of the approval letter, you notified us that the date of manufacture defined in our letter was not consistent with the information in the BLA submission and the dating period was not consistent with the additional stability data submitted on August 20, 2008. Based on the information in the submission and your clarifications we are issuing the following correction.
For Blood Grouping Reagent Anti-e (Monoclonal), the dating period shall be 24 months from the date of ------------------- when stored at 2-8 °C.
We regret any inconvenience these errors have caused.
This information has been placed in your biologics license file. Please keep a copy of this letter available for review at the time of FDA inspections.
Sincerely yours,
Elizabeth Callaghan
Acting Director
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics Evaluation and Research