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:10/11/2017)... Wayne. NJ (PRWEB) , ... October 11, 2017 , ... Personal eye wash is a ... rinse one eye at a time. So which eye do you rinse first if a ... you have Plum Duo Eye Wash with its unique dual eye piece. , ...
(Date:10/11/2017)... ... October 11, 2017 , ... Disappearing forests and increased ... of over 5.5 million people each year. Especially those living in larger cities are ... - based in one of the most pollution-affected countries globally - decided to take ...
(Date:10/10/2017)... (PRWEB) , ... October 10, 2017 , ... ... Science Center’s FirstHand program has won a US2020 STEM Mentoring Award. Representatives of ... award for Excellence in Volunteer Experience from US2020. , US2020’s mission is to ...
(Date:10/10/2017)... ... October 10, 2017 , ... The ... prestigious awards honoring scientists who have made outstanding contributions to analytical ... during Pittcon 2018, the world’s leading conference and exposition for laboratory science, which ...
Breaking Biology Technology:
(Date:10/4/2017)... BLOOMINGTON, Ill. , Oct. 4, 2017  GCE Solutions, a ... powerful new data and document anonymization solution on October 4, 2017. ... the pharmaceutical field to comply with policy 0070 of the European ... documents and data. ... Innovation by GCE Solutions ...
(Date:6/23/2017)... and ITHACA, N.Y. , June 23, ... University, a leader in dairy research, today announced a ... to help reduce the chances that the global milk ... of this dairy project, Cornell University has become the ... the Food Supply Chain, a food safety initiative that ...
(Date:5/6/2017)... RAM Group , Singaporean based ... in biometric authentication based on a novel  ... to perform biometric authentication. These new sensors are based on ... Ram Group and its partners. This sensor will have ... and security. Ram Group is a next generation ...
Breaking Biology News(10 mins):