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:5/28/2016)... ... 28, 2016 , ... May 26, 2016- In search of the K. Warriors, ... event of “K Warriors” on June 4, 2016 at Ashbury Hotel and Suites 600 ... sponsored and hosted by Shaolin Institute and sanctioned by KSF (Kungfu Sanda Federation), This ...
(Date:5/28/2016)... , ... May 28, 2016 , ... In a part of the city where’s it’s ... new farm-to-table Kelowna restaurants is hoping to attract diners with a taste for ... Suites officially opened the doors to Cornerstone Grill, an urban casual restaurant focusing on ...
(Date:5/27/2016)... ... May 27, 2016 , ... Southland Log Homes , designer ... timber frame barn kits, which can be found on its website at SouthlandLogHomes.com. , ... barn plans, and they highlight the craftsmanship of timber post and beam construction. ...
(Date:5/27/2016)... ... May 27, 2016 , ... W.S. Badger Co. ... today that it has been recognized as one of the best small businesses for ... named as one of nine small businesses providing progressive benefits to new parents on ...
(Date:5/27/2016)... ... May 27, 2016 , ... With over 60 percent ... the demand for a sustainable product to aid in the rehabilitation process has steadily ... the recovery of individuals with hemiplegia due to stroke. , Ekso Bionics has now ...
Breaking Medicine News(10 mins):
(Date:5/25/2016)... SPRINGS, Florida , May 25, 2016 ... Business Conference & Expo earlier this month, the numbers ... As revenues continue to climb into the billions, more ... the newly released 4th Edition State of Legal Marijuana ... Frontier, a cannabis-focused data-analysis firm, much of the increase ...
(Date:5/25/2016)... , May 25, 2016 Digital Health ... to it by the US Patent and Trademark ... technology includes proprietary processes for electronic opt-­in and ... and wellness programs, HIPAA compliance and otherwise. ... "Our technology allows for ...
(Date:5/25/2016)... , May 25, 2016 ... the precision of circulating tumour DNA (ctDNA) analysis ... the appointment of Professor Clive Morris ... leadership across the clinical development programme, scientific collaborations, ... help deliver significant improvements in clinical outcomes for ...
Breaking Medicine Technology: