NORCROSS, Ga., June 26 /PRNewswire-FirstCall/ -- Immucor, Inc., (Nasdaq/NM: BLUD), a global leader in providing automated instrument-reagent systems to the blood transfusion industry, announced that yesterday the Food and Drug Administration ("FDA"), in an administrative action based on an early January 2009 inspection, issued a notice of intent to revoke the Company's biologics license with respect to its Reagent Red Blood Cells and Anti-E (Monoclonal) Blood Grouping Reagent product. The FDA has not ordered the recall of any of the Company's products.
"We take our regulatory responsibilities very seriously. We have been working diligently to improve our quality systems and processes, including the deficiencies identified by the FDA, with Our Quality Process Improvement Project. We are committed to completing this Project as quickly as possible," stated Dr. Gioacchino De Chirico, Immucor's President and Chief Executive Officer.
During its fiscal third quarter of 2009, the Company formalized efforts to improve its quality systems through the Quality Process Improvement Project. The Project expanded the role of consultants hired in April 2008. During fiscal 2009, the Company spent more than $2 million on the Project with the costs primarily consisting of consulting fees. As previously reported, during fiscal 2010, the Company expects to spend between $4.0 million and $4.5 million on the Project. The Company expects the Project to be completed during its third fiscal quarter of 2010.
"We have kept the FDA informed of the Project's objectives and progress by providing written updates to them on a monthly basis that detail our plans for corrective actions as well as the implementation of the correction action plans to prevent recurrence. The FDA has acknowledged that they are aware of our efforts to correct their identified deficiencies, but the letter indicates the FDA's action is bas
|SOURCE Immucor, Inc.|
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