07/19/2013 18:16 FAX 301 827 2857 BER OBRR @ooo2/0012 oo, ? DEPARTMENT OF HEALTH & HUMAN SERVICES Pubic Haein Service Food and Drug Admiioraton 1401 Rocke Pike Rocke, MO 70852-1448 July 19, 2013 Diagnostic Grifols, S.A. RECEIVED Attention: Mr. Joaquin Alberto Tamparillas 2410 Lillyvale Avenue JUL- 19.2013 e Las Angeles, CA 90032 peasoorraton © 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. SIN ‘Name of Biological Products BL 125449/0 Blood Grouping Reagent, Anti-A (Murine Monoclonal) BL 125450/0 Blood Grouping Reagent, Anti-B (Murine Monoclonal) BL 125451/0 Blood Grouping Reagent, Anti-C (Monoclonal) BL 125452/0 Blood Grouping Reagent, Anti-D (Monoclonal)(IgM) BL 125453/0 Blood Grouping Reagent, Anti-E (Monoclonal) BL 125454/0 Blood Grouping Reagent, Anti-c (Monoclonal) BL 125455/0 Blood Grouping Reagent, Anti-e (Monoclonal) BL 125456/0 Blood Grouping Reagent, Anti-A,B (Murine Monoclonal) BL 125457/0 Blood Grouping Reagent, Amti-K (Monoclonal) Under this license, you are approved to mamufacture 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.07/19/2013 18:16 FAX 301 827 2857 BER OBRR (ooos/oo1z Page 2 - Mr. Alberto Tamparillas ‘The dating period for products listed above shall be 12 months from the date of manufacture ‘when stored at 2-25 °C. 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 125470 and 125474. You may not distribute any lots of product until you receive a notification of release from the Director, Ceater 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 Isbeling of the products listed above or in the manufacturing facilities. ‘You nmist 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.07/19/2013 18:17 FAX 301 827 2857 (BER OBRR (ooo4/o012 ‘Page 3 - Mr. Alberto Tamparillas 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 350A. 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. Sincerely yours, for Dr. Jay Epstein Mary A. Malarkey Jay S. Epstein, MD Director Director Office of Compliance and Office of Blood Research and Review Biologics Quality Center for Biologics Center for Biologics Evaluation and Research Evaluation and Research Enclosure07/19/2013 18:17 FAK 301 827 2857 BER OBRR oo0s/oo12 oad and Drug Administration 1401 Rocke Pe Roche, MD 20852-1448 —_ DEPARTMENT OF HEALTH & HUMAN SERVICES f Pubic Hath Sere & July 19, 2013 Our STN: BL 125445/0 Diagnostic Grifols, S.A. RECEIVED Attention: Mr. Joaquin Alberto Tamparillas 20Lilyale Aves WL-19 2013 Los Angeles, CA 90032 7 ry Atfors Or Dear Mr. Alberto Tamparillas: ‘We are issuing Department of Health and Human Services U.S. License No. 1887 to Diagnostic Grifols, S.A., located in 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 product Anti-Human Globulin. Anti- ‘Human Globulin is indicated for the detection of in-vivo and in-vitro coating of red blood cells using column agglutination technology. Under this license, you are approved to manufacture Anti-Human Globulin at your facility in Barcelona, Spain. You may label your product with the proprietary names DG Gel® § Anti-IgG (Rabbit) and DG Gel® 8 T/S/ Mono and market it as a gel card. 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 aise concems or controversial issues which would have benefited from an advisory committee discussion. ‘The dating period for Anti-Human Globulin shall be 12 months from the date of manufacture when stored at 2-25 °C. The date of manufacture shall be defined as the date when the ‘manufacture of the first gel type for the card is performed. Please submit samples of the product in final containers together with protocols showing results. of all applicable tests to STNs 125445 and 125474. You may not distribute any lots of product until you receive a notificetion 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 Anti-Human Globulin, or in the manufacturing facilities,