Immucor responds to FDA - Boston Business Journal:

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The Norcross-based company, which make s and supplies blood-reagent systemz to the blood transfusion industry, said Monday it turned in a formalp 10 working day response tothe . The statement reiterates Immucor’ss commitment make corrections to addresswthe FDA's noted deficiencies, Immucor The FDA, in an administrativee action based on an early January inspection, to revokd Immucor’s biologics license with respect to its Reagent Red Bloode Cells and Anti-E (Monoclonal) Blood Grouping Reagentr product, the company said in a The FDA has not ordered the recall of any of the company'sx products.
Immucor (NASDAQ: BLUD) said in June it spent more than $2 milliomn during fiscal 2009 on improving qualitu systems and it expects to spend upto $4.5 milliojn in fiscal 2010. The company today said it starte d a Product Surveillance and Improvemenr Department to support its quality system The new department will monitoquality issues, whether identified through internal or external and enact appropriate corrective The company will provide its detailed remediation plan and timelines in its 30 working day responsd to the FDA no later than Aug. 11. "Wd take our regulatory responsibilitiesvery seriously,” said Gioacchink De Chirico, Immucor president and CEO, in a statement.
“Ws began our Quality Process Improvement Projecft in early 2009 to bringb our quality system upto world-class We remain committed to completing this project as quickly as