Immucor (BLUD) Said FDA Issues Notice To Revoke License, Company Responds
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Immucor, Inc., (Nasdaq: BLUD) announced that yesterday the 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.
CEO Dr. Gioacchino De Chirico said, "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."
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.
NOTE: Shares of BLUD are currently halted
CEO Dr. Gioacchino De Chirico said, "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."
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.
NOTE: Shares of BLUD are currently halted
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