Navigation Links
Immucor Submits 10-Day Response to FDA; Establishes Product Surveillance and Improvement Department
Date:7/13/2009

NORCROSS, Ga., July 13 /PRNewswire-FirstCall/ -- Immucor, Inc. (Nasdaq: BLUD), a global leader in providing automated instrument-reagent systems to the blood transfusion industry, today announced the submission of its formal 10 working day response to the Food and Drug Administration's ("FDA") administrative action, which was announced on June 26, 2009.

This formal 10-day response reiterates the Company's commitment to implement corrective actions that not only address the FDA's noted deficiencies but also establish a world-class quality system. The Company will provide its detailed remediation plan and timelines in its 30 working day response to the FDA no later than August 11, 2009.

"We take our regulatory responsibilities very seriously. We began our Quality Process Improvement Project in early 2009 to bring our quality system up to world-class standards," stated Dr. Gioacchino De Chirico, Immucor's President and Chief Executive Officer. "We remain committed to completing this Project as quickly as possible."

Immucor previously announced that it had received a notice of intent to revoke its biologics license from the FDA with respect to its Reagent Red Blood Cells and Anti-E (Monoclonal) Blood Grouping Reagent products. This administrative action was based on a January 2009 inspection. The notice has a revised effective date of June 30, 2009.

The FDA has not ordered the recall or banned the sale of any of the Company's products.

New Product Surveillance and Improvement Department Established

The Company also announced today the creation of a Product Surveillance and Improvement Department to support the quality system initiative underway. With a focus on product quality, this new department will provide a single internal focal point to monitor quality issues, whether identified through internal or external sources, and initiate the appropriate corrective actions.

"We will continue to evaluate our operations and organization to ensure they are in line with our commitment to develop high quality systems," stated Dr. De Chirico. "Our new Product Surveillance and Improvement Department is an important example of our drive to modernize our quality approach."

About Immucor

Founded in 1982, Immucor manufactures and sells a complete line of reagents and systems used by hospitals, reference laboratories and donor centers to detect and identify certain properties of the cell and serum components of blood prior to transfusion. Immucor markets a complete family of automated instrumentation for all of its market segments. For more information on Immucor, please visit our website at www.immucor.com.


'/>"/>
SOURCE Immucor, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Immucor to Announce Fiscal Fourth Quarter Financial Results on Thursday, July 23, 2009
2. Immucor Announces Fiscal Year 2010 Guidance
3. Immucor to Announce Fiscal 2010 Guidance on Monday, June 1, 2009
4. Immucor to Present at the Bank of America and Merrill Lynch 2009 Health Care Conference
5. Immucor Receives Subpoena From Department of Justice
6. Immucor Announces Fiscal Third Quarter Results
7. Immucor Announces New Vice President, Operations
8. Immucor Announces Fiscal Second Quarter Results; Raises Fiscal 2009 EPS Guidance
9. Immucor Closes BioArray Acquisition
10. Immucor Schedules Fiscal 2009 Guidance Call
11. Immucor Responding to FDA Warning Letter
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology: