Product Approval Information
August 14, 2008
Our STNS: Please see below.
Biotest Medical Diagnostics GmbH
Attention: Dr. Rolf Vornhagen
Industriestrasse 1
D-63303 Dreieich
GERMANY
Dear Dr. Vornhagen:
We have approved your biologics license applications for the Blood Grouping Reagents listed below effective this date. You are hereby authorized to introduce or deliver for introduction into interstate commerce, these Blood Grouping Reagents under your existing Department of Health and Human Services U.S. License No. 1798. These Blood Grouping Reagents are indicated for the determination of the blood group antigens on red blood cells using the tube test.
Our STNs |
Product Proper Name |
Cell Line |
Fill Volume |
Dating Period |
Date of Manufacture (DOM) |
|---|---|---|---|---|---|
BL 125212/0 |
Anti-Fy a (Monoclonal) |
DG-FYA-02 |
2 ml |
24 months |
Date of --------- |
BL 125214/0 |
Anti-s (Monoclonal) |
P3YAN3 |
2 ml |
24 months |
Date of -------- |
BL 125216/0 |
Anti-S (Monoclonal) |
MS 94 |
2 ml |
24 months |
Date of -------- |
Under this authorization, you are approved to manufacture these Blood Grouping Reagents at your facility in Dreieich, Germany. You may label your Blood Grouping Reagent products with the proprietary name Seraclone® and market them in the fill volumes indicated above.
The dating periods for these Blood Grouping Reagents shall be 24 months from the date of manufacture when stored at 2-8oC. The date of manufacture is defined as the date of ----------------------------------------------------------------------------------------------------------------------------------------------------------------------
Please submit samples of each of these products in final containers together with protocols showing results of all applicable tests. You may not distribute any lots of product until you receive a notification of release from the Director, Center for Biologic Evaluation and Research (CBER).
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 these products, 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.
We did not refer your applications to the Blood Products Advisory Committee because the mechanisms of manufacturing monoclonal reagents and their use in hemagglutination testing in immunohematology are well-understood. Our review of information submitted in your BLAs, including the study design and trial results, did not raise concerns or controversial issues which would have benefited from an advisory committee discussion.
Sincerely yours,
/Jay S. Epstein, MD/
Jay S. Epstein, MD
Director
Office of Blood Research and Review
Center for Biologics Evaluation and Research