Navigation Links
Immucor Submits 10-Day Response to FDA; Establishes Product Surveillance and Improvement Department
Date:7/13/2009

NORCROSS, Ga., July 13 /PRNewswire-FirstCall/ -- 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 10 working day response to the Food and Drug Administration's ("FDA") administrative action, which was announced on June 26, 2009.

This formal 10-day response reiterates the Company's commitment to implement corrective actions that not only address the FDA's noted deficiencies but also establish a world-class quality system. The Company will provide its detailed remediation plan and timelines in its 30 working day response to the FDA no later than August 11, 2009.

"We take our regulatory responsibilities very seriously. We began our Quality Process Improvement Project in early 2009 to bring our quality system up to world-class standards," stated Dr. Gioacchino De Chirico, Immucor's President and Chief Executive Officer. "We remain committed to completing this 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. 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 or banned the sale of any of the Company's products.

New Product Surveillance and Improvement Department Established

The Company also announced today the creation of a Product Surveillance and Improvement Department to support the quality system initiative underway. With a focus on product quality, this new department will provide a single inte
'/>"/>

SOURCE Immucor, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. Immucor to Announce Fiscal Fourth Quarter Financial Results on Thursday, July 23, 2009
2. Immucor Announces Fiscal Year 2010 Guidance
3. Immucor to Announce Fiscal 2010 Guidance on Monday, June 1, 2009
4. Immucor to Present at the Bank of America and Merrill Lynch 2009 Health Care Conference
5. Immucor Receives Subpoena From Department of Justice
6. Immucor Announces Fiscal Third Quarter Results
7. Immucor Announces New Vice President, Operations
8. Immucor Announces Fiscal Second Quarter Results; Raises Fiscal 2009 EPS Guidance
9. Immucor Closes BioArray Acquisition
10. Immucor Schedules Fiscal 2009 Guidance Call
11. Immucor Responding to FDA Warning Letter
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/30/2014)... WEDNESDAY, July 30, 2014 (HealthDay News) -- It can happen ... television, dresser or computer monitor and gets critically injured ... of a young child should look around their homes and ... a child. Imagining it is better than it becoming a ... Emergency Physicians, said in a college news release. Between ...
(Date:7/30/2014)... known to fuel cancer as well as evolutionary changes ... events that occur randomly throughout the genome. , However, ... the formation of multiple mutations that arise simultaneously and ... clustered mutations are frequently found in regions where chromosomal ... journal Cell Reports , may one day lead ...
(Date:7/30/2014)... Pennsylvania (PRWEB) July 30, 2014 Visitors ... have contributed over $8,500 to ensure its protection. Bob ... presents a check to the Delaware Highlands Conservancy for ... program. The small $2-per-stay donations add up fast, as ... of the Upper Delaware River Region. , The Kiesendahl ...
(Date:7/30/2014)... 2014) The phrase "we caught it early" is possibly ... midst of a cancer diagnosis. Combating cancer in its ... certain part of the body, gives patients the best ... colon, prostate and other forms of cancer are touted ... providers recommend cancer screenings as a precautionary measure, especially ...
(Date:7/30/2014)... ... ... ... , UCLA researchers interviewed people with diverticulitis and ... in the peer-reviewed journal Quality of Life Research , a UCLA team led by Dr. Brennan Spiegel interviewed patients in great ...
Breaking Medicine News(10 mins):Health News:Tip-Over Furniture Can Kill Kids 2Health News:Biologists describe mechanism promoting multiple DNA mutations 2Health News:Pocono Mountain Resort Guests Contribute Over $8500 to Protect Land in 6 Short Months 2Health News:UK psychologist creates patient tool to assist with lung cancer screening decision 2Health News:UK psychologist creates patient tool to assist with lung cancer screening decision 3Health News:Diverticulitis patients reveal psychological, physical symptoms long after acute attacks 2Health News:Diverticulitis patients reveal psychological, physical symptoms long after acute attacks 3
... America, doctors who look after animals are best placed ... , Urging veterinarians to work more closely with ... Julie Gerberding, director of the Atlanta-based federal Centers for ... of the last 14 new infectious diseases that have ...
... till now; as she was seen sporting a T-shirt with ... figure Andy Warhol . ,The socialite, who ... in social service after finishing jail term, was spotted visiting ... present at a screening of Michael Moore's latest documentary Sicko. ...
... acid to flour considerably reduces congenital malformations . ... Social and Preventive Medicine, has suggested that the addition ... 46 percent slump in the incidence of congenital neural ... ,Such deformations either result in the ...
... a young person drinks is largely determined by how much others ... more, a new study has found . ,The study ... men, and people with positive expectations regarding alcohol drink more. ... to 25 years, most of whom did not live at home. ...
... the largest in the US, is believed to have agreed ... such settlement in recent history . ,The amount, ... plaintiff, exceeded earlier reports that the settlement would be between ... orders the Servites, Claretians and Oblates will be ...
... three from Brisbane, Queensland in Australia died on September 23, ... She was apparently felled by a toxic combination of alcohol ... ,She had gone on the cruise with her 12-year-old ... with. ,Toxicology reports later revealed that the ...
Cached Medicine News:Health News:Vets To Team Up With Human Health Specialists 2Health News:Adding Folic Acid to Flour Lessens Congenital Malformations 2Health News:Los Angeles Diocese Opts for Huge Payout in Sexual Abuse Cases 2Health News:Inquest of Date-rape Drug Victim Attracts Wide Attention in Australia 2Health News:Inquest of Date-rape Drug Victim Attracts Wide Attention in Australia 3
(Date:7/30/2014)... Fla. , July 30, 2014  Today the US ... indoor and outdoor sun tanning or sun burns stating they ... statement Surgeon, General Boris Lushniak , says that "skin ... types and that too much exposure to indoor and outdoor ... for Dermatology and Aesthetic Medicine, in Boca Raton, ...
(Date:7/30/2014)... , July 30, 2014  El Camino Hospital, a ... care, is utilizing the Leaf Patient Monitoring system to ... and movement of patients susceptible to bed sores. ... month-long, 138-patient study of the system, which showed dramatic ... Turning patients regularly is the one of the most ...
(Date:7/30/2014)... YORK , July 30, 2014 ... is available in its catalogue: mHealth ... http://www.reportlinker.com/p0356852/mHealth-and-Home-Monitoring-–-6th-Edition.html Executive summary ... are delivered, leading to better outcomes, decreased costs ... market for mHealth solutions is still in an ...
Breaking Medicine Technology:Indoor and Outdoor Sun Tanning or Sun Burns Directly Linked to Deadly Melanoma Skin Cancer 2El Camino Hospital Utilizes Cutting-Edge Leaf Patient Monitor System to Help Reduce Risk of Pressure Ulcers 2El Camino Hospital Utilizes Cutting-Edge Leaf Patient Monitor System to Help Reduce Risk of Pressure Ulcers 3mHealth and Home Monitoring - 6th Edition 2mHealth and Home Monitoring - 6th Edition 3mHealth and Home Monitoring - 6th Edition 4mHealth and Home Monitoring - 6th Edition 5mHealth and Home Monitoring - 6th Edition 6mHealth and Home Monitoring - 6th Edition 7mHealth and Home Monitoring - 6th Edition 8mHealth and Home Monitoring - 6th Edition 9mHealth and Home Monitoring - 6th Edition 10mHealth and Home Monitoring - 6th Edition 11
... Pharmaceuticals, Inc. (NYSE Amex: INO ), a ... against cancers and infectious diseases, has expanded its scientific ... in the fields of vaccines and cancer immunotherapeutics. Joining ... Professor of the Scripps Research Institute and founder of ...
... The Board of Directors of MSA (NYSE: MSA ... President of the company, responsible for Global Product Leadership.  Dr. ... 1, will assume the role of President of MSA International, ... his new role, Dr. Muschter will become a member of ...
Cached Medicine Technology:Inovio Pharmaceuticals Adds Two Medical Innovators to Its Scientific Advisory Board 2Inovio Pharmaceuticals Adds Two Medical Innovators to Its Scientific Advisory Board 3Inovio Pharmaceuticals Adds Two Medical Innovators to Its Scientific Advisory Board 4Inovio Pharmaceuticals Adds Two Medical Innovators to Its Scientific Advisory Board 5MSA Elects Dr. Thomas Muschter to Vice President 2
2.5V Halogen source, fiber-optic delivery, 2.5X magnification....
Pocket-sized instrument with 2.5X magnification....
Pocket-sized instrument. All Keeler otoscopes have bright halogen illumination for clear and accurate visualization of aural canal. Lithium-ion batteries with quick recharge capability. Ring rheos...
Otoscope with 4X magnification lens, swivellable to both sides, with removable cover glass to insert external instruments. Sealed system allowing for pneumatic otoscopy. 2.5V halogen source....
Medicine Products: