September 27, 2012 Approval Letter - ALBAsera Blood Group Reagents
Alba Bioscience Limited
Attention: Mr. John Allan
21 Ellen’s Glen Road
Edinburgh EH17 7QT
Dear Mr. Allan:
We have approved your biologics license applications for Blood Grouping Reagents, Anti-K, Anti-Fya,Anti-Fyb, Anti-Wra and Anti-s effective this date. You are hereby authorized to introduce or deliver for introduction into interstate commerce, Blood Grouping Reagents, Anti-K, Anti-Fya,Anti-Fyb, Anti-Wra and Anti-s under your existing Department of Health and Human Services U.S. License No. 1807. The Blood Grouping Reagents listed below are indicated for the detection and identification of K, Fya, Fyb, Wra, or s positive red blood cells respectively by indirect agglutinin.
STN Name of Biological Products
Blood Grouping Reagent, Anti-K
Blood Grouping Reagent, Anti-Fya
Blood Grouping Reagent, Anti-Fyb
Blood Grouping Reagent, Anti-Wra
Blood Grouping Reagent, Anti-s
Under this authorization, you are approved to manufacture Blood Grouping Reagents, Anti-K, Anti-Fya,Anti-Fyb, Anti-Wra, Anti-s at your facility in Liberton, Edinburgh, United Kingdom. You may label your products with the proprietary names Anti-K ALBAsera®, Anti-Fya ALBAsera®,Anti-Fyb ALBAsera®, Anti-Wra ALBAsera®, Anti-s ALBAsera® Blood Grouping Reagents and will market it in 5 mL or 10 mL vials.
We did not refer your application to the Blood Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues which would have benefited from an advisory committee discussion.
The dating period for Blood Grouping Reagents Anti-K, Anti-Fya,Anti-Fyb, Anti-Wra, Anti-s shall be 24 months from the date of manufacture when stored at 2-8 °C. The date of manufacture shall be defined as the last date of pre-fill potency testing. The dating period for your in vitro substance shall be 24 months when stored at 2-8 °C.
Please submit final container samples of the product 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 Biologics Evaluation and Research (CBER).
You must submit information to your biologics license application for our review and written approval under 21 CFR 601.12 for any changes in, including but not limited to, the manufacturing, testing, packaging or labeling of Blood Grouping Reagents Anti-K, Anti-Fya,Anti-Fyb, Anti-Wra, Anti-s or in the manufacturing facilities.
You must submit reports of biological product deviations under 21 CFR 600.14. You should identify and investigate all manufacturing deviations promptly, 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 Form FDA 356h. Please provide a PDF electronic copy as well as three original paper copies for circulars and other labels.
Two draft copies of the proposed introductory promotional labeling may be voluntarily submitted for advisory comment with a Form FDA 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448.
You must 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 product is characterized as a device as well as a biological, 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, P.O. Box 3002, Rockville, Maryland 20847-3002.
Jay S. Epstein, M.D.
Office of Blood Research and Review
Center for Biologics
Evaluation and Research