The U.S. Food and Drug Administration today announced that Terumo Cardiovascular Systems Corporation (TCVS) of Ann Arbor, Mich., and two of its officers, Mark A. Sutter, president and chief executive officer, and Mark Lincoln, vice president of Quality Assurance and Operations, have signed a consent decree of permanent injunction.
Category Archives: Food Safety News
FDA, EMA announce pilot for parallel assessment of Quality by Design applications
The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have launched a new pilot program that will allow parallel evaluation of relevant development and manufacturing data components, known as Quality by Design (QbD), of new drug marketing applications that are submitted to both agencies.
FDA approves imaging agent for central nervous system scans
The U.S. Food and Drug Administration today approved Gadavist (gadobutrol), a gadolinium-based contrast agent, for use in patients undergoing magnetic resonance imaging (MRI) of the central nervous system.
Maryland sprout processor enters into consent decree with the FDA
The Food and Drug Administration announced today that Vegi-Pak Farm LLC of Mt. Airy, Md., and its president, Sun Ja Lee, and general manager, Brian W. Lee, signed a consent decree recently prohibiting them from processing, holding and distributing bean sprouts due to their failure to comply with federal food safety laws.
Vegi-Pak Farm grows, processes, packages and distributes ready-to-eat soybean sprouts and holds and distributes tofu and mung bean spouts. The products are sold to markets in Maryland, Virginia and Washington, D.C. DSK
ONE World Enterprises Recalls O.N.E. Coconut Water Due To Mold
ONE World Enterprises, LLC is recalling O.N.E. Coconut Water, packaged in 11.2 oz Tetra Pak cartons with Lot code 12E1004, UPC # 894991001104 and Sell-by date of May 1, 2011, due to the potential oxidation of the product that may permit the growth of mold. The affected product is isolated to a single lot number and the company is currently utilizing Corrective And Preventative Action (CAPA) procedures to identify why this problem exists, which was discovered after receiving a small number of consumer complaints.
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Vitalabs, Inc. Issues Voluntary Recall for Specific Lots of Whey Protein Isolate
Vitalabs, Inc., Jonesboro, GA is voluntarily recalling four specific lot numbers of Whey-26 Protein Powder due to concerns over potential Salmonella contamination.
Salmonella is an organism which can cause serious and sometimes fatal infections in young
children, frail or elderly people, and others with weakened immune systems.
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FDA approves device to maintain blood flow during artery bypass brain surgery
The U.S. Food and Drug Administration today approved a surgical kit that allows neurosurgeons to reroute blood flow around an aneurysm or a tumor in the brains of patients at greater risk of stroke during standard bypass surgery.
FDA, Justice Department take action against McNeil-PPC Inc.
The U.S. Food and Drug Administration announced today that a consent decree of permanent injunction has been filed against McNeil-PPC and two of its officers for failing to comply with current good manufacturing practice requirements as required by federal law.
FDA approves Benlysta to treat lupus
The U.S. Food and Drug Administration today approved Benlysta (belimumab) to treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs.
FDA: E. coli O157:H7 cases linked to hazelnuts
Fast Facts
· DeFranco & Sons of Los Angeles, Calif. is voluntarily recalling bulk and consumer-packaged in-shell hazelnuts and mixed-nut products containing in-shell hazelnuts.
· The recalled products are linked to seven cases of Escherichia coli O157:H7 in Michigan, Minnesota and Wisconsin and may cause serious illness.
· Consumers who have purchased bulk in-shell hazelnuts or mixed-nut products containing in-shell hazelnuts should check with the retailer to determine if they are subject to the recall, or throw the nuts away. (SY)
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