Navigation Links
FDA Accepts Immucor's Response to Warning Letter
Date:6/6/2008

NORCROSS, Ga., June 6 /PRNewswire-FirstCall/ -- Immucor, Inc., (Nasdaq: BLUD), a global leader in providing automated instrument-reagent systems to the blood transfusion industry, announced that today the FDA notified the company that it has reviewed Immucor's response to the previously-reported warning letter, and Immucor's proposed corrective actions appear to be adequate. The FDA stated it would evaluate the implementation and effectiveness of those corrective actions, as well as Immucor's overall compliance, at its next inspection.

The warning letter, which related to Immucor's internal quality system, was dated May 2, 2008, and the company responded on May 22, 2008, detailing the corrective actions it proposed to take.

Immucor CEO Dr. Gioacchino De Chirico said: "We take our regulatory responsibilities very seriously and worked diligently to respond to the FDA. We are pleased the FDA accepted our action plan, and was willing to move as quickly as it did. We have already begun implementing the plan."

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 http://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.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. FDA Accepts Zingo(TM) Supplemental New Drug Application to Reduce Pain Associated With Peripheral Needle Insertion Procedures in Adults
2. U.S. Government Accepts $192 Million of sanofi pasteur H5N1 Bulk Vaccine Antigen for Pandemic Stockpile
3. Imaging Diagnostic Systems Accepts Resignations of Outside Directors
4. EMEA Accepts for Review Vidaza(R) Marketing Authorization Application for Higher-Risk Myelodysplastic Syndromes
5. FDA Accepts Ranexa(R) sNDA and NDA for Filing
6. FDA Accepts Sucampos sNDA for Lubiprostone (8 mcg) for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C)
7. FDA Accepts ISO-Vorin(TM) New Drug Application Amendment Submitted by Spectrum Pharmaceuticals
8. Novel Investigational Regimen Combining Radiation Enhancing Agent With Ibritumomab Tiuxetan (Zevalin(R)) Produces High Rate of Complete Responses in Patients With Rituximab-Refractory Follicular Non-Hodgkins Lymphoma
9. Oncolytics Biotech Inc. Announces Publication of Research on Immune Response to REOLYSIN(R) during a Phase I Clinical Trial
10. MannKind Corporation Response to Recent Market Events
11. Sanofi Pasteur Mounts Emergency Response to Yellow Fever Epidemic in Latin America
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... (PRWEB) , ... June 27, 2016 , ... ... operations for Amgen, will join the faculty of the University of North ... adjunct professor of strategy and entrepreneurship at UNC Kenan-Flagler, with a focus on ...
(Date:6/27/2016)... BOSTON , June 27, 2016   Ginkgo ... biology to industrial engineering, was today awarded as ... a selection of the world,s most innovative companies. ... at scale for the real world in the ... organism engineers work directly with customers including Fortune ...
(Date:6/24/2016)... 2016 Epic Sciences unveiled a liquid ... to PARP inhibitors by targeting homologous recombination deficiency ... new test has already been incorporated into numerous ... types. Over 230 clinical trials are ... including PARP, ATM, ATR, DNA-PK and WEE-1. Drugs ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Researchers at ... most commonly-identified miRNAs in people with peritoneal or pleural mesothelioma. Their findings are the ... read it now. , Diagnostic biomarkers are signposts in the blood, lung fluid ...
Breaking Biology Technology:
(Date:5/12/2016)... , May 12, 2016 WearablesResearch.com , ... published the overview results from the Q1 wave of ... recent wave was consumers, receptivity to a program where ... with a health insurance company. "We were ... share," says Michael LaColla , CEO of Troubadour ...
(Date:4/26/2016)... and LONDON , April ... part of EdgeVerve Systems, a product subsidiary of ... today announced a partnership to integrate the Onegini ...      (Logo: http://photos.prnewswire.com/prnh/20151104/283829LOGO ) ... their customers enhanced security to access and transact ...
(Date:4/14/2016)... 2016 BioCatch ™, the ... announced the appointment of Eyal Goldwerger as ... Goldwerger,s leadership appointment comes at a time of ... deployment of its platform at several of the world,s ... discerns unique cognitive and physiological factors, is a winner ...
Breaking Biology News(10 mins):