Immucor responds to FDA - Phoenix Business Journal:

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The Norcross-based company, whicy makes and supplies blood-reagent systems to the bloocd transfusion industry, said Monday it turnecd in a formal 10 working day response tothe . The statemengt reiterates Immucor’s commitment make corrections to addressthe FDA'ds noted deficiencies, Immucor The FDA, in an administrative action based on an early January inspection, to revoker Immucor’s biologics license with respect to its Reagent Red Bloo d Cells and Anti-E Blood Grouping Reagent product, the company said in a The FDA has not ordered the recallk of any of the company'se products.
Immucor (NASDAQ: BLUD) said in June it spent more than $2 million during fiscal 2009 on improvinyg quality systems and it expects to spencd upto $4.5 million in fiscal 2010. The compant today said it started a Productg Surveillance and Improvement Department to support its qualitusystem initiative. The new departmenyt will monitor quality whether identified through internal orexternal sources, and enact appropriatre corrective actions. The company will provide its detailede remediation plan and timelinea in its 30 working day responsd to the FDA no laterthan Aug. 11.
"Wew take our regulatory responsibilities very said GioacchinoDe Chirico, Immucor president and CEO, in a “We began our Quality Process Improvementg Project in early 2009 to briny our quality system up to world-class standards. We remain committed to completing this project as quicklyas