NORCROSS, Ga., Aug. 10 /PRNewswire-FirstCall/ -- Immucor, Inc. , a global leader in providing automated instrument-reagent systems to the blood transfusion industry, today announced the submission of its formal 30 working day response to the Food and Drug Administration's ("FDA") administrative action, which was announced on June 26, 2009.
"We are committed to quality," stated Dr. Gioacchino De Chirico, Immucor's President and Chief Executive Officer. "We are making good progress with our Project to create a world-class quality system and meet our regulatory responsibilities. We are working to complete our Quality Process Improvement Project as quickly as possible."
The FDA has not ordered the recall of any of the Company's products or restricted Immucor from selling any products.
With the creation of the COO role, the Company has restructured its organization to further support its quality initiatives. The reporting structure for worldwide manufacturing and distribution operations has been centralized. This realignment supports the Company's quality initiatives by enabling the standardization of best practices across the manufacturing and distribution organizations. The reporting structure for the Company's North American sales, marketing and customer solutions functions has been centralized. Unifying these functions ensures a consistent customer experience.
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.
Immucor, Inc.