NORCROSS, Ga., July 13 /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 10 working day response to the Food and Drug Administration’s (“FDA”) administrative action, which was announced on June 26, 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.”
The FDA has not ordered the recall or banned the sale of any of the Company’s products.
“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.”
Immucor, Inc.