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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