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 based on their January 2009 inspection. The FDA has not performed an inspection since January 2009," stated Dr. De Chirico.
Per the FDA's letter, the Company has 10 working days to respond to the FDA's administrative action and 30 days to submit a remediation plan. The Company will use the extensive remediation work already underway and already documented in detail to the FDA to facilitate its response.
"We believe our Quality Process Improvement Project will result in Immucor having a world-class quality system. We are committed to achieving this end as quickly as possible," stated Dr. De Chirico.
Founded in 1982, Immucor manufactures and sells a complete line of reagents and systems used by hospitals, reference laboratories and donor centers to detect and identify certain properties of the cell and serum components of blood prior to transfusion. Immucor markets a complete family of automated instrumentation for all of our market segments.
For more information on Immucor, please visit our website at www.immucor.com.
Statements contained in this press release that are not statements of historical fact are "forward-looking statements" as that term is defined under federal securities laws, including, without limitation, all statements concerning Immucor's expectations, beliefs, intentions or strategies for the future. Forward-looking statements may be identified by words such as "plans," "expects," "believes," "anticipates," "estimates," "projects," "may," "will," "could", "should" and other words of similar meaning. Investors are cautioned not to place undue reliance on any forward-looking statements, and Immucor assumes no obligation to update any forward-looking statements. Immucor urges investors to consider the risks detailed in the Company's filings with the Securities and Exchange Commission.
|SOURCE Immucor, Inc.|
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