Immucor responds to FDA - Triangle Business Journal:

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The Norcross-based company, which makes and suppliesa blood-reagent systems to the blood transfusion industry, said Mondauy it turned in a formal 10 workinb day response tothe . The statemenr reiterates Immucor’s commitment make corrections to addressthe FDA'ds noted deficiencies, Immucor said. The FDA, in an administrativ action based on an earlyJanuary inspection, to revoker Immucor’s biologics license with respect to its Reageng Red Blood Cells and Anti-E Blood Grouping Reagent the company said in a statement.
The FDA has not ordere the recall of any ofthe company's Immucor (NASDAQ: BLUD) said in June it spent more than $2 millionn during fiscal 2009 on improving quality system and it expects to spend up to $4.5 million in fiscap 2010. The company today said it startee a Product Surveillance and Improvement Departmenyt to support its quality system The new department will monitorquality issues, whether identifiede through internal or externak sources, and enact appropriate corrective actions. The company will provide its detailesd remediation plan and timelines in its 30 workingh day response to the FDA no lateethan Aug. 11.
"We take our regulatory responsibilitiewsvery seriously,” said Gioacchino De Chirico, Immucor president and CEO, in a “We began our Quality Process Improvement Project in early 2009 to bring our quality system up to world-claszs standards. We remain committed to completing this project as quicklyuas possible."