October 26, 2016

Consent Decree Shuts Down Kwong Tung Foods

The U.S. District Court for the District of Minnesota has entered a consent decree of permanent injunction against Kwong Tung Foods Inc., doing business as Canton Foods to prevent the distribution of adulterated noodles and sprouts. The complaint was filed on July 14, 2016 at the request of the FDA. The complaint alleges that Kwong Tung Foods violated the federal Food, Drug, and Cosmetic Act by preparing, packing, and/or holding noodles and sprouts under insanitary conditions so the food may have been contaminated with filth or rendered injurious to health. The facility, according to the complaint, failed to exclude pests and rodents, failed to maintain equipment, and failed to ensure adequate employee sanitation. Principal Deputy Assistant Attorney General Benjamin C. Mizer, … [Read more...]

Consent Decree Issued Against Native American Enterprises

The U.S. District Court for the District of Kansas entered a consent decree of permanent injunction last week between the United States and Native American Enterprises of Wichita, Kansas. The action was brought for "significant and ongoing violations of federal food safety laws and regulations." The government alleges that the company's ready to eat refried beans and sauces are adulterated, in that they have been prepared, packed, or held under unsanitary conditions so the food is contaminated with filth or has been rendered injurious to health. The company can no longer sell any FDA regulated products until it comes into compliance with the Federal Food, Drug, and Cosmetic Act. The company was sent a warning letter in August 2013, telling the owners to correct its violations or … [Read more...]

Feds Block Sale of Henry’s Sprouts After Listeria Recalls, Insanitary Conidtions

The U.S. Food and Drug Administration and the U.S. Department of Justice have blocked the sale of Henry's Farm bean sprouts which have been recalled several times since 2012 for Listeria. The United States District Court for the Eastern District of Virginia entered a consent decree of permanent injunction between the United States and Henry’s Farm Inc. of  Woodford, Va.  and its owner Soo C. Park, today. The action, which "prohibits Henry’s Farm, Inc. from receiving, processing, manufacturing, preparing, packing, holding and distributing ready-to-eat soybean and mung-bean sprouts," comes after the FDA and state health officials found multiple food safety violations at Henry's Farm, and regulations. “It’s the FDA’s responsibility to protect consumers from potentially harmful food … [Read more...]

Dietary Supplement Distributor Ordered to Stop Selling Product

A U.S. District Judge for the Middle District of Florida, James S. Moody, Jr. has entered a consent decree of permanent injunction between the United States and James R. Hill of Florida, doing business as Viruxo LLC, a distributor of dietary supplements, for unlawfully distributing an unapproved new drug and misbranded drug. The complaint also includes a civil fraud charge, by promoting the product to cure, mitigate, treat, or prevent a disease despite the absence of well-controlled clinical studies or any other credible scientific evidence to support the claims. Hill was sent a warning letter in April 2011, stating that the therapeutic claims he is making are untrue. The FDA has not approved the product for any use. The product was marketed as a treatment for herpes. In addition, the … [Read more...]

Consent Decree Entered Against Sullivan Harbor Farm

U.S. District Judge Jon D. Levy of the district of Maine entered a consent decree of permanent injunction against Mill Stream Corporation, doing business as Sullivan Harbor Farm at the request of the FDA. This facility processes and sells vacuum packed, ready-to-eat fish products, including hot and cold smoked salmon, trout, and arctic char, and has a "long history of recurring violations," according to the press release. FDA inspectors found that the company did not control for Clostridium botulinum hazards in their fish products and did not comply with good manufacturing practice requirements as required by law. FDA inspectors found evidence of rodent feces and mold at the facility during inspections. Melinda K. Plaisier, the FDA's associate commissioner for regulatory affairs, … [Read more...]

FDA Orders Juice Manufacturer to Cease Operations

The US Food and Drug Administration (FDA) has ordered Sun Valley Juice Company of Ketchum, Idaho to stop "receiving, processing, preparing, packing, holding, and distributing juice" until the agency determines that the company is in compliance with food safety laws and regulations. The company has been sent a letter ordering it to cease operations within five days. The company has compiled. Several attempts were made to help the company comply with regulations before it was shut down. In 2006, a court-ordered agreement, called a consent decree, was signed by a federal judge. That agreement, between the FDA and Sun Valley Juice Company, stated that the company would establish and implement a hazard prevention plan. But FDA investigators have found the company has been out of compliance … [Read more...]

L.A. Star Seafood Company Ordered to Close Down

The U.S. District Court for the Central District of California has entered a consent decree of permanent injunction against L.A. Star Seafood Company of Los Angeles and its corporate officers. The company was producing adulterated seafood products. The complaint alleges that the sanitation practices at the facility were deficient. Acting Assistant Attorney General Benjamin C. Mizer said, "the failure to actively plan for and control the presence of bacteria and neurotoxins commonly found in seafood processing facilities can pose a serious risk to the public health." FDA inspections in 2013 and 2014 documented a pattern of insanitary conditions. Listeria monocytogenes bacteria were found at the facility. Workers at the facility did not adequately clean surfaces and utensils for … [Read more...]

FDA Closes Jensen’s Old Fashioned Smokehouse

The FDA has closed Jensen's Old Fashioned Smokehouse in Seattle, Washington, after environmental samples confirmed the presence of Listeria monocytogenes in the facility. Inspectors found the pathogenic bacteria in food processing and storage areas. The facility is subject to a consent decree of permanent injunction that was entered in 2001. Under that decree, the company "agreed to comply with requirements to control food safety hazards and ensure that its products are not adulterated." To resume production, Jensen's must meet several requirements, including cleaning and sanitizing the facility and hiring an expert to develop a Sanitation Standard Operation Procedure, along with an environmental monitoring program for Listeria. In addition, the company must test samples of all … [Read more...]

FDA Granted Decree of Permanent Junction Against T&T Cattle

A federal judge has entered a consent decree of permanent injunction against Gregory T. Troost, doing business as T&T Cattle and T&T Cattle Pearl, along with manager Mark Mourton, for violations including illegally administering animal drugs for uses not approved by the FDA. Inspections in January 2002, January 2006, September 2010, and October through November 2012 found that the facility had violated several provisions of the Federal Food Drug and Cosmetics Act. Specifically, the defendants offered for slaughter seven dairy cows with illegal levels of drug residues. Cows had tissues that tested positive for elevated levels of penicillin and sulfadimethoxine. People can have severe adverse reactions to those drugs even at very low levels and the drugs can harm those sensitive … [Read more...]

Consent Decree Issued Against Vermont Dairy Farm

The FDA has announced that the District Court for Vermont has entered a consent decree of permanent injunction against Lawson Farm of Irasburg, Vermont for selling cows and bull calves for human food that contain illegal drug residues. The decree prevents the farm and its owners from purchasing or selling animals for use as food unless and until they take action to assure that animals with illegal drug residues do not enter teh food supply. The defendants must also maintain written records to identify which animals have been medicated and maintain a drug inventory. The FDA has sent warning letters to the farm for similar violations. The letter states that dairy cows had high levels of penicillin in the edible tissues of cattle. The farm also "held animals under conditions that are so … [Read more...]

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