April 18, 2019 Approval Letter - Blood Grouping Reagent, Anti-Cw (Monoclonal)

FDA/CBER

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PDF April-18-2019-Approval-Letter-Blood-Grouping-Reagent-Anti-Cw-(Monoclonal) 
Our STN: BL 125687/0

BLA APPROVAL April 18, 2019

Immucor, Inc. Attention: Mr. Howard Yorek 3130 Gateway Drive Norcross, GA 30071

Dear Mr. Yorek:

Please refer to your Biologics License Application (BLA) submitted June 26, 2018, received June 27, 2018, under section 351(a) of the Public Health Service Act (PHS Act) for Blood Grouping Reagent, Anti-Cw (Monoclonal).

LICENSING

We have approved your BLA for Blood Grouping Reagent, Anti-Cw (Monoclonal)

effective this date. You are hereby authorized to introduce or deliver for introduction

into interstate commerce, Blood Grouping Reagent, Anti-Cw (Monoclonal) under your

existing Department of Health and Human Services U.S. License No. 0886,

manufactured from Blood Grouping Reagent, Anti-Cw (Monoclonal)(For Further

Manufacturing Use) supplied by (b) (4)

, under a shared manufacturing

arrangement. The Blood Grouping Reagent, Anti-Cw (Monoclonal) is indicated for the

detection of the Cw (RH8) antigen on red blood cells by direct agglutination by tube

method.

MANUFACTURING LOCATIONS
Under this license, you are approved to manufacture Blood Grouping Reagent, Anti-Cw (Monoclonal) at your facility located at Norcross, Georgia. You may label your product with the proprietary name Gamma-clone® Blood Grouping Reagent, Anti-Cw (Monoclonal) and will market it as approved in your license application.
ADVISORY COMMITTEE
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 trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
w ww.fda.gov

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DATING PERIOD

The dating period for Blood Grouping Reagent, Anti-Cw (Monoclonal) shall be 24

months from the date of manufacture when stored at 1 - 10 °C. The date of manufacture

shall be defined as the date the (b) (4)

the final product

containers.

FDA LOT RELEASE

You are not currently required to submit samples but are required to submit the protocols showing results of applicable tests of future lots of Blood Grouping Reagent, Anti-Cw (Monoclonal) to the Center for Biologics Evaluation and Research (CBER) for release by the Director, CBER, under 21 CFR 610.2(a). We will continue to monitor compliance with 21 CFR 610.1 requiring completion of tests for conformity with standards applicable to each product prior to release of each lot.

BIOLOGICAL PRODUCT DEVIATIONS

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, packaging, 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

MANUFACTURING CHANGES

You must submit information to your BLA 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 Blood Grouping Reagent, Anti-Cw (Monoclonal) or in the manufacturing facilities.

LABELING

We hereby approve the draft package insert labeling submitted under amendment 7, dated March 28, 2019. This is a reminder that as of September 24, 2014, medical devices that are licensed under the PHS Act are subject to certain provisions of the final Unique Device Identifier (UDI) rule. These provisions include the requirement to provide a UDI on the device label and packages (21 CFR 801.20), format dates on the

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device label in accordance with 21 CFR 801.18, and submit data to the Global Unique Device Identification Database (GUDID) (21 CFR 830 Subpart E). Additionally, please identify each device identifier implemented for the subject device, and the device identifiers that have been discontinued for the subject device as a labeling change in an annual report consistent with 21 CFR 601.12(f)(3). For more information on these requirements, please see the UDI website at http://www.fda.gov/udi.
Please submit all final printed labeling as a PDF electronic copy (eCopy) at the time of use and include implementation information on Form FDA 356h as appropriate.
Two draft copies of the proposed introductory advertising or promotional labeling may be voluntarily submitted for advisory comment with a completed Form FDA 2253 to the Advertising and Promotional Labeling Branch 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
ADVERSE EVENT REPORTING
You must submit adverse experience reports in accordance with the Medical Device Reporting (MDR) requirements for medical devices (21 CFR 803) as required by 21 CFR 600.80(k)(2). Because your product is characterized as a device as well as a biologic, submit these reports to the MedWatch System using MedWatch Reporting Form 3500A or an electronic equivalent. Please refer to the Questions and Answers about eMDR ­ Electronic Medical Device Reporting ­ Guidance for Industry, User Facilities and FDA Staff at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/ucm175805.htm.

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Required reports are to be submitted to:
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
Sincerely,
Nicole C. Verdun, MD Office Director Office of Blood Research and Review Center for Biologics Evaluation and Research