Immucor responds to FDA - Triangle Business Journal:

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The Norcross-based company, whichb makes and supplies blood-reagenr systems to the blood transfusion industry, said Monday it turned in a formalp 10 working day response tothe . The statement reiteratesz Immucor’s commitment make corrections to addressthe FDA'xs noted deficiencies, Immucor said. The FDA, in an administrative action based on an earlhyJanuary inspection, to revoke Immucor’sw biologics license with respect to its Reagent Red Blood Cells and Anti-E (Monoclonal) Bloos Grouping Reagent product, the companyu said in a statement.
The FDA has not orderesd the recall of any ofthe company's Immucor (NASDAQ: BLUD) said in June it spenrt more than $2 million during fiscall 2009 on improving quality systems and it expects to spend up to $4.5 millionn in fiscal 2010. The company today said it starter a Product Surveillance and Improvemen t Department to support its quality system The new department will monito rquality issues, whether identifiefd through internal or external sources, and enacyt appropriate corrective actions. The company will providw its detailed remediation plan and timelineas in its 30 working day response to the FDA no latedrthan Aug. 11.
"We take our regulatory responsibilities very said GioacchinoDe Chirico, Immucoe president and CEO, in a “We began our Quality Procese Improvement Project in early 2009 to bring our qualityg system up to world-class standards. We remainb committed to completing this projecty as quicklyas possible."