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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
Rockville, MD 20852-1448
July 26, 2005
Biotest AG
ATTN: Mr. Michael Campbell
Olympus America Inc.
3131 West Royal Lane
Irving, TX 75063-3104
Dear Mr. Campbell:
We are issuing Department of Health and Human Services U.S. License No. 1702 to Biotest AG, Dreieich, Germany, under the provisions of section 351(a) of the Public Health Service Act controlling the manufacture and sale of biological products. The license authorizes Biotest AG to introduce or deliver for introduction into interstate commerce, those products listed below for which Biotest AG has demonstrated compliance with establishment and product standards.
| STNs: BL |
Product Proper Name |
Clone ID |
Proprietary Name |
| 125094/0 |
Blood Grouping Reagent,
Anti-A (Murine Monoclonal) |
A003 |
Component of Erytype S |
| 125095/0 |
Blood Grouping Reagent,
Anti-B (Murine Monoclonal) |
B005 |
Component of Erytype S |
| 125096/0 |
Blood Grouping Reagent,
Anti-A,B (Murine Monoclonal Blend) |
Anti-A- BS63
Anti-B- BS85 |
Component of Erytype S |
| 125097/0 |
Blood Grouping Reagent,
Anti-D (Monoclonal) (IgM) |
BS226
BS232 |
Component of Erytype S |
| STN: BL |
Product Proper Name |
Proprietary Name |
| 125098/0 |
Anti-Human Globulin,
Anti-IgG (Rabbit) |
Anti-Human Globulin Solidscreen II |
Under this license, Biotest AG is authorized to manufacture the products listed above for exclusive use on the Tango Automated Analyzer.
The Blood Grouping Reagents are dried on each microstrip and will be used to perform a single ABO Grouping and D Typing or label confirmation for donor ABO Grouping and/or D Typing. The source material for the Blood Grouping Reagents is manufactured at -------------------------------------------------------------------------- and will be shipped to Biotest AG for further manufacture into a finished reagent under a contract manufacturing agreement.
The Anti-Human Globulin will be used to detect the sensitization of Reagent Red Blood Cells by immunoglobulins. The source material for the Anti-Human Globulin is manufactured at --------------------------------- and will be shipped to Biotest AG for further manufacture into a finished reagent under a contract manufacturing agreement.
Under this license, Biotest AG is approved to manufacture the Blood Grouping Reagents listed above at their facility in Dreieich, Germany. Biotest AG may label their products with the proprietary name, Erytype S and market them in eight-well microstrips contained in a twelve-strip plate holder. Biotest AG is also approved to manufacture Anti-Human Globulin at this facility and may label that product with the proprietary name, Anti-Human Globulin, Anti IgG Solidscreen II and market it in 55 ml vials.
Please insure that Biotest AG submits final container samples of the products in final containers together with protocols showing results of all applicable tests. Biotest AG may not distribute any lots of product until Biotest AG receives a notification of release from the Director, Center for Biologics Evaluation and Research (CBER).
Olympus America Inc. (on Biotest's AG's behalf) must submit information to their biologics license application for our review and written approval under 21 CFR 601.12 for any changes in the manufacturing, testing, packaging or labeling of their products, or in the manufacturing facilities.
The dating period for the Blood Grouping Reagents and Anti-Human Globulin shall be 18 months from the date of manufacture when stored at 2-8 oC. The date of manufacture shall be defined as the date of filtration.
We acknowledge your written commitments as described in your letter of July 14, 2005 as outlined below:
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Submit adverse experience reports in accordance with the Medical Device Reporting requirements for medical devices (21 CFR 803) as required by 21 CFR 600.81(k)(2). Since Biotest AG products are characterized as devices as well as biologicals, submit these reports to the MedWatch System using Med Watch 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, MD 20847-3002.
Olympus America Inc. (on Biotest AG's behalf) 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-3486 to the Director, Office of Compliance and Biologics Quality, Center of 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 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 the final printed advertising and promotional labeling should be submitted at the time of initial dissemination, accompanied by a FDA Form 2253.
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim of superiority over other products unless you have submitted data to support such claims to us and had them approved.
Sincerely yours,
--- signature ---
Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Jay S. Epstein, M.D.
Director
Office of Blood Research and Review
Center for Biologics Evaluation and Research
Link to corrected letter
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