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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Product Approval Letter - ALBAclone

Product Approval Information - Licensing Action

 

September 14, 2007

Our STNS: SEE BELOW

Alba Bioscience, Inc.
Attention: Noel Brown
1005 Lamond Avenue
Durham, NC 27701

 

Dear Mr. Brown:

 

We are issuing Department of Health and Human Services U.S. License No. 1723 to Alba Bioscience, Inc., Durham, North Carolina, 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 Blood Grouping Reagents listed below. These products are indicated for the in vitro detection and identification of human blood group antigens by direct agglutination.

Our Submission Tracking Numbers (STN) Name of Biological Product Cell Line(s)
BL 125129/0 Blood Grouping Reagent, Anti-A (Murine Monoclonal) LA2
BL 125130/0 Blood Grouping Reagent, Anti-B (Murine Monoclonal) LB3
BL 125131/0 Blood Grouping Reagent, Anti-A,B (Murine Monoclonal) LA2/LB3/ES15

BL 125132/0

 

BL 125132/0

Blood Grouping Reagent, Anti-D (Monoclonal) (IgM)

 

Blood Grouping Reagent, Anti-D (Monoclonal) (IgM)

LDM1

 

LDM3

BL 125133/0 Blood Grouping Reagent, Anti-E (Monoclonal) DEM1
BL 125134/0 Blood Grouping Reagent, Anti-c (Monoclonal) H48
BL 125135/0 Blood Grouping Reagent, Anti-k (Murine Monoclonal) LKL1
BL 125136/0 Blood Grouping Reagent, Anti-M (Murine Monoclonal) LM1
BL 125137/0 Blood Grouping Reagent, Anti-N (Murine Monoclonal) LN3
BL 125138/0 Blood Grouping Reagent, Anti-Le a (Murine Monoclonal) LEA2
BL 125139/0 Blood Grouping Reagent, Anti-Le b (Murine Monoclonal) LEB2
BL 125140/0 Blood Grouping Reagent, Anti-Lu b (Murine Monoclonal) LU2
BL 125143/0 Blood Grouping Reagent, Anti-D (Monoclonal) (IgM Blend) LDM1/ESD1-M
BL 125144/0 Blood Grouping Reagent, Anti-D (Monoclonal Blend) LDM3/ESD1

Under this license, you are approved to manufacture Blood Grouping Reagents at your contract facility in Edinburgh, UNITED KINGDOM. You may label your products with the proprietary name ALBAclone® and will market them in 2 mL, 5mL, or 10 mL screw-cap glass dropper vials, as specified in your applications.

The dating period for the ALBAclone® Blood Grouping Reagents shall be 24 months from the date of manufacture when stored at 2 - 8 °C. The date of manufacture shall be defined as the date of the final filtration of the bulk product. Following the final filtration, no reprocessing is allowed without prior approval from the Agency.

Please submit 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 the manufacturing, testing, packaging or labeling of the Blood Grouping Reagents, or in the manufacturing facilities.

We acknowledge your written commitments as described in your letter of June 27, 2007 as outlined below:

Postmarketing Studies not subject to reporting requirements of 21 CFR 601.70.

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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 your products are characterized as devices 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, 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.

Sincerely yours,

--- signature ---

Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Jay S. Epstein, MD
Director
Office of Blood Research and Review
Center for Biologics Evaluation and Research

 

 

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