Immucor responds to FDA - Atlanta Business Chronicle:

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The Norcross-based company, which makes and supplies blood-reagent systemsz to the blood transfusion industry, said Monda it turned in a formal 10 working day response tothe . The statemeny reiterates Immucor’s commitment make corrections to addressdthe FDA's noted deficiencies, Immucorf said. The FDA, in an administrative actionn based on an earlhJanuary inspection, to revoke Immucor’s biologicsw license with respect to its Reagent Red Blood Cells and Anti-E (Monoclonal) Blood Grouping Reagent the company said in a statement. The FDA has not orderedr the recall of any ofthe company'sz products.
Immucor (NASDAQ: said in June it spent more than $2 million durinhg fiscal 2009 on improving quality systems and it expect to spend upto $4.5 million in fiscalo 2010. The company today said it started a Product Surveillance and Improvemeng Department to support its quality system The new department will monitorrquality issues, whether identified througg internal or external sources, and enact appropriatr corrective actions. The compan y will provide its detailed remediation plan and timelinew in its 30 working day response to the FDA no latefrthan Aug. 11.
"We take our regulatoruy responsibilitiesvery seriously,” said Gioacchino De Immucor president and CEO, in a “We began our Quality Process Improvementf Project in early 2009 to bring our quality systemm up to world-class standards. We remain committed to completiny this project as quicklyas