August 14, 2008
Our STNs: Please see table below.
Biotest Medical Diagnostics GmbH
Attention: Dr. Rolf Vornhagen
Dear Dr. Vornhagen:
We have approved your biologics license applications for the products listed below effective this date. You are hereby authorized to introduce or deliver for introduction into interstate commerce, Reagent Red Blood Cells and Reagent Red Blood Cells For Use in Automated Systems under your existing Department of Health and Human Services U.S. License No. 1798. Reagent Red Blood Cells are for use in manual tube testing and Reagent Red Blood Cells For Use in Automated Systems are for use on the TANGO® optimo automated blood grouping and antibody test system.
|Reagent Red Blood Cells|
|BL 125207/0||Biotestcell ® A 1 and B, Biotestcell ® A 2|
Biotestcell ® Pool; Biotestcell ® 1, 2; Biotestcell ® 3
Biotestcell ® I8; Biotestcell ® I11
|Reagent Red Blood Cells For Use in Automated Systems|
|BL 125208/0||Erytypecell® A1 and B|
Biotestcell® Pool; Biotestcell® 1, 2; Biotestcell® 3
Biotestcell® I8; Biotestcell® I11
Under this authorization, you are approved to manufacture Reagent Red Blood Cells and Reagent Red Blood Cells For Use in Automated Systems at your facility in Dreieich, Germany. You may label your products with the proprietary names Biotestcell® and Erytypecell® and market them in -- -- --- 10 ml per glass vial with pipette top closures as indicated in your submissions.
The dating period for Reagent Red Blood Cells and Reagent Red Blood Cells For Use in Automated Systems shall be 63 days from the date of manufacture when stored at 2-8 oC. The date of manufacture shall be defined as “the earliest possible collection date of the donor blood” as defined in your application. ---------------------------------------------------
You are not required to routinely submit samples of future lots of Reagent Red Blood Cells and Reagent Red Blood Cells For Use in Automated Systems to the Center for Biologics Evaluation and Research (CBER) for release by the Director, CBER, under 21 CFR 610.2. You are required to submit samples and protocols in accordance with 21 CFR 660.36.
You must submit information to your biologics license applications for our review and written approval under 21 CFR 601.12 for any changes in the manufacturing, testing, packaging or labeling of Reagent Red Blood Cells and Reagent Red Blood Cells For Use in Automated Systems, or in the manufacturing facilities.
We acknowledge your commitment to provide summaries of your shipping validation study(ies) and your stability studies as soon as the data are available.
Submit adverse experience reports in accordance with the Medical Device Reporting requirements for medical devices (21 CFR 803) as required by 21 CFR 600.80 (k)(2). Since your products are characterized as devices as well as biologicals, submit these reports to the MedWatch System using MedWatch Reporting Form 3500A. Required reports should be submitted to the Food and Drug Administration, Center for Devices and Radiological Health, Medical Device Reporting, PO Box 3002, Rockville, Maryland 20847-3002.
You must submit reports of biological product deviations under 21 CFR 600.14. You promptly should identify and investigate all manufacturing deviations, including those associated with processing, testing, packing, labeling, storage, holding and distribution. If the deviation involves a distributed product, may affect the safety, purity, or potency of the product, and meets the other criteria in the regulation, you must submit a report on Form FDA-3486 to the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Rockville, MD 20852-1448.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h and FDA Form 2567 as appropriate. Please provide a PDF-format electronic copy as well as original paper copies (ten for circulars and five for other labels). In addition, you may wish to submit two draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. Two copies of final printed advertising and promotional labeling should be submitted at the time of initial dissemination, accompanied by FDA Form 2253.
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have submitted data to support such claims to us and had them approved.
/Jay S. Epstein, MD/
Jay S. Epstein, MD
Office of Blood Research and Review
Center for Biologics Evaluation and Research