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."
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.|
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