October 12, 2022 - The United States filed a complaint to stop a food manufacturer in Antioch, California, from making and selling adulterated and misbranded noodle products, the Justice Department announced today.

In a civil complaint for permanent injunction filed on Oct. 12, the United States alleges that Cuong T. Do, through his business, Cali Rice Valley Inc., violated the Federal Food, Drug and Cosmetic Act (FDCA) by failing to follow preventive controls requirements and causing uncooked and ready-to-eat wheat and rice noodles to become adulterated or misbranded.

“Food manufacturers must ensure the safety of their products,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work closely with FDA and take action against food manufacturers that operate under insanitary conditions.”

“The FDA plays a vital role in safeguarding the U.S. food supply and helping to ensure that our food is not contaminated before it reaches consumers,” said Associate Commissioner for Regulatory Affairs Judy McMeekin, Pharm.D. “We take our responsibility seriously and will continue to protect consumers by taking action against those who threaten the safety and quality of the products we regulate.”

The complaint, which was filed in the U.S. District Court for the Northern District of California, alleges that FDA investigators visited Do’s Cali Rice Valley facility in 2021 and 2022 and found insanitary conditions, such as insects on ingredients, ingredient bags with holes, rainwater leaking into ingredient storage rooms, utensils and equipment that were not sanitized, and poor employee practices. The complaint alleges that such conditions can create an ideal environment for the growth of harmful bacteria. The complaint also alleges that FDA’s inspections identified violations of preventive controls requirements intended to provide assurance that significant food safety hazards will be controlled and the food manufactured by the facility will not be adulterated or misbranded.

The complaint further alleges that tests from environmental samples taken at Do’s facility detected the bacteria Listeria innocua (L. innocua) in and around food preparation areas. According to the complaint, the presence of L. innocua indicates environmental conditions that also could support the growth of the pathogen Listeria monocytogenes (L. mono). Food contaminated with L. mono can cause symptoms such as diarrhea and vomiting in healthy adults. For vulnerable consumers — including pregnant women, the elderly and the immune-compromised — L. mono can cause more serious effects, such as stillbirths, miscarriages, and death.

The complaint also alleges that the firm’s products are misbranded because they fail to declare the presence of the allergens in wheat and egg, among other violations.

According to the complaint, Do sells his noodles throughout the Bay Area. The government’s lawsuit seeks an injunction that would require Do and Cali Rice Valley to make sanitation improvements and comply with federal food safety requirements before making or distributing any more noodle products.

Trial Attorney David Crockett of the Justice Department’s Consumer Protection Branch is handling the case with the assistance of Senior Counsel Claudia Zuckerman of the FDA’s Office of the Chief Counsel.

The claims made in the complaint are allegations that, if the case were to proceed to trial, the government must prove by a preponderance of the evidence.

Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch.

Attachment(s): Download Complaint