April 17, 2024

Consent Decree Filed Against Cali Rice For Violations of the FDCA

A consent decree was filed by the FDA against Cali Rice for manufacturing food in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). The civil complaint was filed on October 11, 2023, and the government alleged that Cali Rice Valley Inc. violated the law at the company's facility in Antioch, California, and in its previous facility in San Francisco by manufacturing and distributing adulterated food products. Cali Rice makes ready to eat rice noodles, packaged in retail and bulk sizes, along with bakery products. The company allegedly did not conduct an adequate hazard analysis or establishment and implement preventive controls, leaving their food at risk of contamination with pathogens. The complaint also alleges that the FDA inspected the company's facilities four … [Read more...]

The Exclusive Poultry Illegally Hired Children For Dangerous Jobs

The Exclusive Poultry illegally hired children for dangerous  jobs, robbed workers of wages, and retaliated by firing employees, according to the U.S. Department of Labor. The California poultry processor has agreed to pay nearly  $3.8 million in back wages, damages, and penalties. Investigators found that The Exclusive Poultry and related companies established by the owner allegedly employed children as young as 14 to debone poultry using sharp knives and to operate power-driven lifts to move pallets. The children also worked excessive hours in violation of federal child labor laws. In addition, the company retaliated against workers who cooperated with investigators by cutting their wages. The Exclusive Poultry and owner Tony Bran are subject to a consent judgment entered by … [Read more...]

Consent Decree Against Evig Dietary Supplement Manufacturer

A consent decree of permanent injunction has been entered against Evig LLC, a dietary supplement manufacturer and distributor, along with the company's CEO, and Premium Production LLC and its manager, according to the FDA. These companies produce and market Balance of Nature Products, with false label claims. Those corporations are located in St. George, Utah. The U.S. District Court for the District of Utah, Central Division entered the consent decrees. The FDA has not approved the Balance of Nature products for any use. The company has made claims that its products could be used to diagnose, cure, mitigate, treat, or prevent diseases such as cancer, heart disease, cirrhosis, diabetes, asthma, and COVID-19. And Evig LLC violated current good manufacturing practice (CGMP) … [Read more...]

Win.IT America Violated Child Labor Laws By Employing Children

Win.IT America has entered a federal consent judgment to stop illegally employing children and to not violate federal child labor laws in the future. The court prohibits the Hebron, Kentucky facility from "oppressively" violating child labor laws. The order was entered in the U.S. District Court for the Eastern District of Kentucky on September 8, 2023. Investigators with the department's Wage and Hour Division discovered the children working in the distribution center in August 2023. The two children, ages 11 and 13, were employed for months. The violations included employing a child to operate a forklift, which is a hazardous occupation for workers under the age of 18, and told another child to pick orders in the warehouse, which is a prohibited occupation for workers under the … [Read more...]

Court Enjoins Company From Distributing Adulterated Supplements

A federal court has permanently enjoined an Arizona company from distributing adulterated supplements. The complaint, which was filed on October 12, 2022, enjoined Global Vitality, Inc., doing business as Enzyme Process International, from distributing these adulterated supplements, which were also misbranded. The complaint was filed in the U.S. District Court of the District of Arizona. FDA alleges that inspectors visited the Global Vitality facility in Chandler, Arizona many times, in 2012, 2014, 2016, 2019, and in June and July 2021, and found violations of regulatory requirements meant to control the risk of hazards in dietary supplements. The government also alleges that the company failed to follow current good manufacturing practices for dietary supplements. In addition, a … [Read more...]

FDA Updates Activities on Infant Formula Supply Challenges

The FDA has updated its activities on infant formula supply challenges. The agency is trying to increase the supply and availability of infant formula since the Abbott Nutrition plant in Sturgis, Michigan closed because the FDA found Cronobacter contamination in the environment. The agency warned parents not to use certain powdered infant formula products from that facility on February 17, 2022. A recall was issued by Abbott the same day. Cronobacter is a bacteria that can cause serious illness and death in infants, particularly premature babies and those with other medical conditions. A consent decree of permanent injunction was filed in the U.S. District Court for the Western District of Michigan on May 16, 2022. Abbott has agreed to take corrective actions following the FDA … [Read more...]

Bravo Packing Ordered to Stop Distribution of Adulterated Pet Food

Bravo Packing has been ordered by the courts to stop distributing pet food adulterated with Salmonella bacteria. This order was on behalf of the FDA. The complaint was filed on March 15, 2022 and alleges that Bravo Packing violated the Federal Food, Drug, and Cosmetic Act by distributing animal food that was contaminated with pathogens, and by causing animal food to become adulterated while it was held for sale.   Samples that were collected by the FDA during inspections of the Bravo Packing facility in July 2019 and April 2021 allegedly contained Salmonella, a pathogen that can cause serious illness in both pets and humans. Salmonella can be transferred to people from animal food through handling of the food or through direct contact with infected animals. Principal … [Read more...]

Felix Custom Smoking Enjoined From Distributing Seafood Products

Felix Custom Smoking has been enjoined from distributing seafood products through a consent decree filed on March 9, 2022 by the FDA and the U.S. Justice Department. The owner of that establishment, Diane Zollinger, has allegedly violated the Federal Food, Drug, and Cosmetic Act (FDCA) by distributing "adulterated ready-to-eat seafood products, including fish jerky and cold- and hot-smoked salmon," according to the complaint. The business sells products directly to consumers from its location and through farmers markets, as well as providing custom processing for fishermen and other wholesalers. The facility is located in Monroe, Washington. The claims made in the complaint are allegations that, if the case were to proceed to trail, the government must prove by a preponderance of … [Read more...]

Consent Decree Against Salud Natural Entrepreneur Supplements

A consent decree has been issued against Salud Natural Entrepreneur, Inc. (Salud) for allegedly distributing adulterated and misbranded dietary supplements and unapproved new drugs. The company allegedly claimed that theoe products would cure, mitigate, treat, or prevent diseases such as cancer, diabetes, heart disease, and high blood pressure. The decree was filed by the Department of Justice in the Northern District of Illinois on March 3, 2022 on behalf of the FDA. The decree also alleges that Salud did not comply with current Good Manufacturing practices regulations that are designed to help ensure the safety of nutritional supplements. And also, the decree alleges that on one occasion Salud used ingredients that had tend positive for Salmonella bacteria in manufacturing a … [Read more...]

Natural Solutions Foundation Must Stop Distributing COVID Treatment

A federal court permanently enjoined Natural Solutions Foundation, a New Jersey entity, and its principals from distributing unapproved and misbranded drugs that were marketed as a treatment for COVID-19. The company was distributing a "nano silver" product that they claimed would prevent, treat, or cure COVID-19. The enforcement action was prosecuted by Trial Attorney Brianna M. Gardner of the Civil Division’s Consumer Protection Branch, with assistance from Associate Chief Counsel for Enforcement Jaclyn Martínez Resly of the FDA’s Office of Chief Counsel. The complaint was filed at the request of the FDA, and states that nano silver is not generally recognized by qualified experts as safe and effective to prevent, treat, or cure COVID-19, and that these claims are not supported by … [Read more...]

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