A federal court has enjoined a California company to stop manufacturing and distributing adulterated food products that violate the Federal Food, Drug, and Cosmetic Act (FDCA).
In a civil complaint filed on Oct. 11, 2022, the United States alleged that Cali Rice Valley Inc., along with its general manager and co-owner, Cuong T. Do, violated the FDCA at the company’s current facility in Antioch, CA, and its previous facility in San Francisco by manufacturing and distributing adulterated food products.
Cali Rice Valley makes and distributes food products, including ready-to-eat rice noodles packaged in retail, bulk sizes, and bakery products. The complaint alleged that the defendants violated the FDCA by failing to adequately conduct a hazard analysis or establish and implement preventive controls, leaving their food products at risk of contamination with disease-causing bacteria.
The complaint also stated the Food and Drug Administration inspected the company’s facilities four times, including in 2019, 2020, 2021, and 2022, and that many of the most recent violations were repeat violations the FDA had identified in earlier inspections. According to the complaint, the FDA issued Cali Rice Valley several warnings regarding alleged deficiencies at its facilities, including a warning letter to the company in 2020.
“Food manufacturers have an important duty to ensure the quality and safety of their products,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Justice Department will continue to work closely with the FDA and take action against manufacturers who fail to abide by laws designed to protect public health.”
“The FDA takes its responsibility seriously to ensure the foods we eat are safe and meet our rigorous standards for food safety,” said Associate Commissioner Michael Rogers for Regulatory Affairs. “It is always a firm’s responsibility to ensure the consistent safety of the products they produce, and we will seek to hold them accountable when they fail to meet those standards.”
The company and the government agreed to settle the suit and be bound by a consent decree of permanent injunction. The negotiated consent decree entered by the court permanently enjoins the defendants from violating the FDCA. It requires, among other things, that they stop manufacturing, processing, packing, holding, or distributing adulterated food articles.
Trial Attorney David G. Crockett Jr. and Senior Trial Attorney Roger Gural of the Civil Division’s Consumer Protection Branch prosecuted this case, with assistance from Senior Counsel Claudia J. Zuckerman of the FDA’s Office of Chief Counsel.
The claims resolved by the consent decree are allegations only, and there has been no determination of liability.
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