FDA Revokes Immucor's (BLUD) Biologics License with Respect to its Reagent Red Blood Cells and Anti-E Blood Grouping Reagent

June 26, 2009 8:42 AM EDT

Immucor, Inc., (Nasdaq: BLUD) 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.

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.[SM]

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