Vaccines, Blood & Biologics

December 11, 2014 Approval Letter - MP Diagnostics HTLV Blot 2.4


Our STN: BL 125475/0

MP Biomedicals Asia Pacific Pte. Ltd.
Attention: Ms. Liane R. Miller
c/o MP Biomedicals, LLC
3 Hutton Centre Drive, Suite 100
Santa Ana, CA 92707

Dear Ms. Miller:

We are issuing Department of Health and Human Services U.S. License No. 1897 to MP Biomedicals Asia Pacific Pte. Ltd., Singapore, 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 Human T-Lymphotropic Virus Types I & II. Human T-Lymphotropic Virus Types I & II is a qualitative enzyme immunoassay intended for confirming the presence of and differentiating antibodies to HTLV-I and HTLV-II in human serum and plasma. It is intended for use as a supplemental (additional, more specific) test for human serum and plasma specimens with repeatedly reactive results by an FDA-licensed HTLV-I/II donor screening test. This test is not intended for use in medical diagnosis. It is intended for use in a manual mode or a semi-automated mode using the MP Diagnostics AutoBlot System 20.

The review of this product was associated with the following National Clinical Trial (NCT) number: 01467024.

Under this license, you are approved to manufacture Human T-Lymphotropic Virus Types I & II at the MP Biomedicals Asia Pacific Pte. Ltd. facility in Singapore. The final formulated product will be distributed from MP Biomedicals Worldwide Distribution Center, Solon, Ohio. You may label your product with the proprietary name MP Diagnostics HTLV Blot 2.4 and market it as approved in your license application.

The dating period for Human T-Lymphotropic Virus Types I & II shall be 15 months from the date of manufacture when stored at 2 – 8o C. The date of manufacture shall be defined as appropriate in accordance with 21 CFR 610.50. We have approved the stability protocol in your license application for the purpose of extending the expiration dating period of your product under 21 CFR 610.12.

Please submit final container samples of the product and each kit component 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 Human T-Lymphotropic Virus Types I & II, 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, at the following address:

Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Ave.
WO71-G112
Silver Spring, MD 20993-0002

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 Advertising and Promotional Labeling Branch, at following address:

Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Ave.
WO71-G112
Silver Spring, MD 20993-0002

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 following address:

Food and Drug Administration
Center for Devices and Radiological Health
MDR Policy Branch
10903 New Hampshire Avenue
WO Bldg. 66, Room 3217
Silver Spring, MD 20993-0002

POSTMARKETING COMMITMENT

We acknowledge your written commitment as described in your letter of October 23, 2014 as outlined below:

MP Biomedicals commits to performing HTLV DNA PCR for at least 25 blood donor specimens that are repeatedly reactive on an HTLV-I/II donor screening assay and have the following banding pattern on the MP Diagnostics HTLV Blot 2.4: p19 only, p24 only, and HGIP. This testing will be performed within 12 months of licensure of the MP Diagnostics HTLV Blot 2.4.

Please submit clinical protocols to your IND, with a cross-reference letter to this biologics license application (BLA), STN BL 125475. Please submit the complete study report three month after completion of the study. If the information in the final study report supports a change in the labeling, the final study report should be submitted as a supplement.

Please use the following designators to label prominently all submissions, including supplements, relating to these postmarketing study commitments as appropriate:

• Postmarketing Study Correspondence
• Postmarketing Study Commitment – Final Study Report
• Supplement Contains Postmarketing Study Commitment – Final Study Report

For each postmarketing commitment not subject to the reporting requirements of 21 CFR 601.70, you may report the status to FDA as a “PMC Submission – Status Update.” The status report for each commitment should include:

• The original schedule for the commitment, and
• The status of the commitment (i.e., pending, ongoing, delayed, terminated, or submitted).

When you have fulfilled your commitment, submit your final report as a Postmarketing Study Commitment – Final Study Report or Supplement Contains Postmarketing Study Commitment – Final Study Report.

Sincerely yours,
 

Mary A. Malarkey
Director
Biologics Quality Center for Biologics
Center for Biologics Evaluation and Research
Evaluation and Research
 

Jay S. Epstein, MD
Director
Office of Blood Research and Review
Center for Biologics
Evaluation and Research

 

Enclosure

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