MnetTV          Digital Library

Search Manufacturing.net Search Manufacturing.net
Today in Manufacturing.Net

Resources
Association Links
Bookstore
Digital Library
Events Calendar
Job Search
What’s New
White Papers

Browse White Papers


News
Featured Articles
Financial News
Global Manufacturing
Government News
Mergers & Acquisitions
News Archive
People in the News

Job Search


Market Sectors
Aerospace
Automotive/Transportation
Chemical/Petroleum
Food/Beverage
Medical
Metals
Pharmaceuticals/Biotech
Plastics/Rubber
Other Manufacturing

Industry Focus
Design & Development
Electrical & Electronics
Energy
Environmental
Facilities & Operations
Labor Relations
Manufacturing Technology
Materials
Quality
Safety
Supply Chain

Amazon

About Us
Editorial Contacts
Advertise with Us

Our Partner Sites
Chem.Info
ECN
Food Manufacturing
IMPO (Industrial Maintenance & Plant Operation)
Medical Design Technology
Pharmaceutical Processing
Product Design & Development
R & D Magazine
Wireless Design & Development
Wireless Week



 


Mnet house ad 120x240



Immucor Says FDA Could Revoke License

Manufacturing.Net - June 26, 2009

Printer Friendly     E-mail to a Colleague


NORCROSS, Ga. (AP) -- Immucor Inc., which makes products used in blood transfusions, said Friday the Food and Drug Administration intends to revoke the company's biologics manufacturing license, citing a January inspection.

The notice is based on a January FDA inspection, though the company said it has been working "diligently" to improve its manufacturing processes. No products are being recalled as a result of the notice.

In May 2008, the FDA warned the company about violations at its Norcross plant that included handling procedures. In some cases, the company had released batches of blood tests that had bacterial contamination before completing an investigation.

Specifically, the notice refers to the company's reagent red blood cells and Anti-E blood grouping reagent product.

"We take our regulatory responsibilities very seriously," said President and CEO Gioacchino De Chirico in a statement. "We have been working diligently to improve our quality systems and processes, including the deficiencies identified by the FDA, with our quality process improvement."

The company spent more than $2 million in fiscal 2009 on improvements. In fiscal 2010, the company expects to spend between $4 million and $4.5 million on improvement projects.

The company now has 10 working days to respond to the FDA's administrative action and 30 days to submit a remediation plan.

Shares of Immucor fell $2.76, or 17.2 percent, to $13.33 in morning trading. The stock reached a five-year low of $11.24 earlier in the trading session.


Printer Friendly     E-mail to a Colleague



Talkback!
Manufacturing.net is pleased to provide you an opportunity to share your opinions on any of the news stories or articles on our site. We reserve the right to edit/remove comments.
Viewing 0 User Comments
Add a Comment


Add a Comment...

E-Mail:
The content of this field is kept private and will not be shown publicly.

Subject:
Comment:

 

     



   





Flatbed trucking, flatbed shipping, flatbed carriers



Aerospace

Bombardier Jet Deliveries Fall In 3Q

Alcoa Investing $110 Million In Ohio Plant

California Pushes Boeing, NASA To Clean Up Toxic Lab


Automotive/Transportation

Mercedes-Benz Sales Up 4 Percent

Alabama Benefits From Georgia's Kia Plant

Prius Continues To Be Top-Selling Car In Japan

Other Manufacturing

Judge Rejects Block On Tobacco Marketing Law

Jayco To Hire, Boost Production At 2 Plants

Dow Corning Pays $175M For 2 Silicon Assets
News Video