May 26, 2018

Vulto Creamery Ordered to Stop Sales for Food Safety Violations

Products made by Vulto Creamery caused a deadly Listeria monocytogenes outbreak in 2017 that sickened eight people in four states. All of the patients were hospitalized. Two people died. And one infection was diagnosed in a newborn. Now the company has been placed under a consent decree of permanent injunction by the U.S. District Court for the Northern District of New York, on behalf of the FDA. The defendants cannot prepare, process, manufacture, pack, and/or hold FDA regulated food products until they can ensure that Listeria monocytogenes bacteria are not present in their food or facility. FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier said in a statement, "We have an obligation to make sure that foods are safe for people to consume. The FDA moved … [Read more...]

Consent Decree Issued Against MyNicNaxs, Maker of Dietary Supplements

A federal court ordered a Florida-based company called MyNicNaxs to stop selling drugs and dietary supplements until it complies with the Federal Food, Drug, and Cosmetic Act and other requirements. The U.S. District Court for the Middle District of Florida has entered a consent decree of permanent injunction against MyNicNaxs of Deltona Florida. The company distributed weight loss and sexual enhancement products, marketed as dietary supplements, directly to consumers online through their websites. Some of these products tested positive for undeclared active pharmaceutical ingredients. Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research said in a statement, "Marketing products with undeclared active pharmaceutical … [Read more...]

Permanent Injunction Entered Against Syfrett Feed Company

The U.S. District Court for the Southern District of Florida has entered a consent decree of permanent injunction against Syfrett Feed Company of Okeechobee, Florida for distributing misbranded and adulterated medicated animal feed. According to the complaint, the company's medicated animal feeds did not list the names of active drug ingredients and did not include adequate instruction for use, including feeding limitations, dose administration, and cautionary statements for the use of drugs in combination with other drugs. The complaint also alleges that the feed was not manufactured in conformity with current good manufacturing practices for medicated feeds. The complaint alleges that the defendants failed to "establish and maintain adequate procedures for the identification, … [Read more...]

Permanent Injunction Closes Dietary Supplement Makers

The U.S. District Court for the District of Colorado has entered a permanent injunction against EonNutra LLC, two related companies, CDSM LLC and HABW LLC, and their owner, to prevent the distribution of "adulterated and misbranded dietary supplements and unapproved and misbranded drugs." The Department alleges that the defendants, who sell about 150 dietary supplement products, violated the Federal Food, Drug, and Cosmetic Act. Several of those products were labeled as dietary supplements, but were marketed as drugs. The company claimed that the product could help treat or prevent diseases such as "heart disease, diabetes, depression, hypertension, osteoporosis, and liver and kidney disorders." According to the complaint, the defendants offered these claims to the public without … [Read more...]

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 Conditions

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...]

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