NORCROSS, Ga., Aug. 10 Immucor, Inc. (Nasdaq: BLUD), a global leader in providing automated instrument-reagent systems to the blood transfusion industry, today announced the submission of its formal 30 working day response to the Food and Drug Administration's ("FDA") administrative action, which was announced on June 26, 2009.
This formal 30-day response details the Company's remediation plan and timelines to correct the FDA's noted deficiencies. The Company's Quality Process Improvement Project, which began in early 2009, serves as the basis for the detailed remediation plan. The Project's goal is to establish a world-class quality system while simultaneously addressing the FDA's noted deficiencies.
"We are committed to quality," stated Dr. Gioacchino De Chirico, Immucor's President and Chief Executive Officer. "We are making good progress with our Project to create a world-class quality system and meet our regulatory responsibilities. We are working to complete our Quality Process Improvement Project as quickly as possible."
Immucor previously announced that it had received a notice of intent to revoke its biologics license from the FDA with respect to its Reagent Red Blood Cells and Anti-E (Monoclonal) Blood Grouping Reagent products. Under this administrative action, the Company has the opportunity to demonstrate or achieve compliance before the FDA initiates revocation proceedings or takes other action. This administrative action was based on a January 2009 inspection. The notice has a revised effective date of June 30, 2009.
The FDA has not ordered the recall of any of the Company's products or restricted Immucor from selling any products.
Organizational Realignment Supports Quality Initiatives
On July 16, 2009, the Company announced the appointment of Geoffrey S. Crouse as Chief Operating Officer, a newly created position. Formerly with Millipore Corporation, Mr. Crouse's experience leading a global laboratory consumables and reagents business similar in size and complexity to Immucor provides additional executive management leadership in the drive to develop a world-class quality system.
With the creation of the COO role, the Company has restructured its organization to further support its quality initiatives. The reporting structure for worldwide manufacturing and distribution operations has been centralized. This realignment supports the Company's quality initiatives by enabling the standardization of best practices across the manufacturing and distribution organizations. The reporting structure for the Company's North American sales, marketing and customer solutions functions has been centralized. Unifying these functions ensures a consistent customer experience.
"Along with our new Product Surveillance and Improvement Department, which provides a single internal focal point to monitor quality issues, these organizational changes support our drive to modernize our approach to quality," stated Dr. De Chirico. "We are instilling quality into every aspect of our organization to ensure we deliver value for our customers and our shareholders."
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 its 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.