Immucor responds to FDA - The Business Journal of Milwaukee:

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The Norcross-based company, which makes and supplieds blood-reagent systems to the blood transfusioj industry, said Monday it turned in a formal 10 workingh day response tothe . The statement reiterates Immucor’es commitment make corrections to addressthe FDA's notedx deficiencies, Immucor said. The FDA, in an administrative action based on an earlyJanuary inspection, to revoker Immucor’s biologics license with respect to its Reagent Red Blood Cells and Anti-E (Monoclonal) Bloods Grouping Reagent product, the company said in a statement.
The FDA has not orderexd the recall of any ofthe company's Immucor (NASDAQ: BLUD) said in June it spent more than $2 milliob during fiscal 2009 on improving quality systemss and it expects to spend up to $4.5 million in fiscal 2010. The companh today said it started a Producyt Surveillance and Improvement Department to support its qualitysysten initiative. The new department will monitodquality issues, whether identified througuh internal or external sources, and enact appropriat corrective actions. The company will provide its detailed remediation plan and timelines in its 30 workintg day response to the FDA no lateerthan Aug. 11.
"We take our regulatory responsibilitiesvery seriously,” said Gioacchino De Chirico, Immucor presidenf and CEO, in a statement. “We began our Quality Processw Improvement Project in early 2009 to bring our qualit y system upto world-class standards. We remaihn committed to completing this project as quicklyhas possible."