Navigation Links
FDA Accepts Immucor's Response to Warning Letter

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 .

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:
(Date:6/23/2016)... - FACIT has announced the creation of a ... Propellon Therapeutics Inc. ("Propellon" or "the Company"), to ... of first-in-class WDR5 inhibitors for the treatment of ... an exciting class of therapies, possessing the potential ... patients. Substantial advances have been achieved with the ...
(Date:6/23/2016)... -- The Prostate Cancer Foundation (PCF) is pleased to announce 24 new ... prostate cancer. Members of the Class of 2016 were selected from a pool ... Read More About the Class of 2016 PCF Young Investigators ... ... ...
(Date:6/23/2016)... , ... June 23, 2016 , ... STACS DNA Inc., ... Leader at the Arkansas State Crime Laboratory, has joined STACS DNA as a Field ... DNA team,” said Jocelyn Tremblay, President and COO of STACS DNA. “In further expanding ...
(Date:6/23/2016)... Andrew D Zelenetz ... Published recently in Oncology ... touchONCOLOGY, Andrew D Zelenetz , discusses the ... is placing an increasing burden on healthcare systems ... With the patents on many biologics expiring, interest ...
Breaking Biology Technology:
(Date:6/15/2016)... 2016 Transparency Market Research ... Market by Application Market - Global Industry Analysis Size Share ... the report, the  global gesture recognition market  was ... is estimated to grow at a CAGR of ... Increasing application of gesture recognition technology ...
(Date:6/2/2016)... The Department of Transport Management (DOTM) of ... project, for the , Supply and Delivery of ... Infrastructure , to Decatur , ... Management Solutions. Numerous renowned international vendors participated in the tendering ... selected for the most compliant and innovative solution. The contract ...
(Date:5/20/2016)... , May 20, 2016  VoiceIt is ... partnership with VoicePass. By working together, ... experience.  Because VoiceIt and VoicePass take slightly different ... engines increases both security and usability. ... excitement about this new partnership. "This ...
Breaking Biology News(10 mins):