Navigation Links
Immucor Submits 10-Day Response to FDA; Establishes Product Surveillance and Improvement Department

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

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:
(Date:11/25/2015)... ... November 25, 2015 , ... In an ongoing Clinical Study conducted by ... Chicago, IL, UV Angel is evaluating the efficacy of its product and its disinfection ... (totaling 30 beds) from May 2014 through October 2015 at a 360-bed, acute-care, academic ...
(Date:11/25/2015)... ... November 25, 2015 , ... “While riding the bus, I saw a passenger ... thought there had to be a convenient and comfortable way to protect them from ... disabled individuals to safely travel during cold or inclement weather. In doing so, it ...
(Date:11/25/2015)... ... , ... Today, Mothers Against Drunk Driving (MADD) learned that the ... the first time since 2011. In 2014, there were 9,967 fatalities involving an alcohol ... National Highway Traffic Safety Administration (NHTSA), 32,675 people were killed in traffic crashes in ...
(Date:11/25/2015)... ... 25, 2015 , ... Castlewood Treatment Center for Eating Disorders, ... as a result of the $20,000 raised at the center’s recent golf ... Club in Eureka, will help individuals who otherwise might not seek treatment for ...
(Date:11/25/2015)... ... November 25, 2015 , ... In honor of Pulmonary Hypertension ... and groups responsible for advancing care for pulmonary hypertension (PH) patients and helping ... public, will receive special recognition throughout 2016 as part of PHA’s 25th anniversary ...
Breaking Medicine News(10 mins):
(Date:11/25/2015)... , Nov. 25, 2015  Trovagene, Inc. (NASDAQ: ... announced that Chief Executive Officer Antonius Schuh, Ph.D., is ... th Annual Piper Jaffray Healthcare Conference. ... New York Palace Hotel in New York ... p.m. EST. Mr. Schuh will be available for one-on-one ...
(Date:11/25/2015)... -- Today AVACEN Medical announced the issue of United States patent No. 9,192,509 ... This patent shields the company,s AVACEN 100 dry heat therapy medical device and specific methods of ... Photo - ... ... ...
(Date:11/25/2015)... DUBLIN , Nov. 25, 2015 ... global pharmaceutical company, and Rugen Therapeutics, a start-up ... treatments for unmet CNS disorders and funded by ... that they have entered into an exclusive collaboration ... therapies for Autism Spectrum Disorders (ASD) and Obsessive ...
Breaking Medicine Technology: