Immucor responds to FDA - Boston Business Journal:

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The Norcross-based company, which makes and suppliees blood-reagent systems to the bloord transfusion industry, said Monday it turnes in a formal 10 working day response tothe . The statement reiterates Immucor’as commitment make corrections to addressthe FDA's noted Immucor said. The FDA, in an administrative action basecd on an earlyJanuart inspection, to revoke Immucor’s biologicss license with respect to its Reagenyt Red Blood Cells and Anti-E (Monoclonal) Blood Grouping Reagenr product, the company said in a The FDA has not ordered the recalo of any of the company's products.
Immucor BLUD) said in June it spent more than $2 milliob during fiscal 2009 on improving quality systemas and it expects to spenf upto $4.5 million in fiscal 2010. The company todayu said it started a Product Surveillance and Improvement Departmenr to support its quality system The new department will monitoequality issues, whether identified through internal or external sources, and enact appropriate corrective actions. The compang will provide its detailed remediation plan and timelines in its 30 workintg day response to the FDA no latedthan Aug. 11.
"We take our regulatory responsibilitieasvery seriously,” said Gioacchino De Chirico, Immucoe president and CEO, in a statement. “We beganb our Quality Process Improvement Project in early 2009 to brinvg our quality system upto world-class We remain committed to completing this project as quickly as possible."