July 19, 2013 Approval Letter - DG Gel Cards
Diagnostic Grifols, S.A.
Attention: Mr. Joaquin Alberto Tamparillas
2410 Lillyvale Avenue
Los Angeles, CA 90032
Dear Mr. Alberto Tamparillas:
We are issuing Department of Health and Human Services U.S. License No. 1887 to Diagnostic Grifols, S.A., Barcelona, Spain, under the provisions of section 351(a) of the Public Health Service Act controlling the manufacture and sale of biological products. The license authorizes you to introduce or deliver for introduction into interstate commerce, those products for which your company has demonstrated compliance with establishment and product standards.
Under this license, you are authorized to manufacture the products listed below indicated for typing blood samples using column agglutination technology.
STN Name of Biological Products
Blood Grouping Regent, Anti -A (Murine Monoclonal)
Blood Grouping Reagent, Anti-B (Murine Monoclonal)
Blood Grouping Reagent, Anti-C (Monoclonal)
Blood Grouping Reagent, Anti-D (Monoclonal)(IgM)
Blood Grouping Reagent, Anti-E (Monoclonal)
Blood Grouping Reagent, Anti-c (Monoclonal)
Blood Grouping Reagent, Anti-e (Monoclonal)
Blood Grouping Reagent, Anti-A,B (Murine Monoclonal)
Blood Grouping Reagent, Anti-K (Monoclonal)
Under this license, you are approved to manufacture the products listed above at your facility in Barcelona, Spain. You may label your products with the proprietary names DG Gel® 8 AB(4x), DG Gel® 8 A/B/D, DG Gel® 8 ABO/Rh + Kell, DG Gel® 8 Rh Pheno and DG Gel® 8 T/S Mono and will market them as gel cards.
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 results, did not raise concerns or controversial issues which would have benefited from an advisory committee discussion.
The dating period for products listed above shall be 12 months from the date of manufacture when stored at 2-25 ºC. The date of manufacture shall be defined as the date when the gel for the gel card is manufactured.
Please submit samples of the products in final containers together with protocols showing results of all applicable tests to STNs --------(b)(4)--------. 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 the products listed above 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.
ADVERSE EVENT REPORTING
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.
Mary A. Malarkey Jay S. Epstein, MD
Office of Compliance and Office of Blood Research and Review
Biologics Quality Center for Biologics
Center for Biologics Evaluation and Research
Evaluation and Research