On July 2, a federal court enjoined a Louisiana company from manufacturing and distributing adulterated food products that violate the Federal Food, Drug, and Cosmetic Act (FDCA).

In a civil complaint filed on June 10, the United States alleged that Freshy Foods, LLC, Team Fresh & Go,LLC, and its owners, Floyd D. James, and Ida M. James, violated the FDCA at their food processing facility in Elmwood, LA, by manufacturing and distributing adulterated food products.

Freshy Foods, LLC and Team Fresh & Go LLC manufactured and distributed ready-to-eat food products, including sandwiches and fruit cups. The complaint alleged that environmental tests in 2023 detected Listeria monocytogenes (L. mono), the pathogen that can cause listeriosis, in the defendants’ facility. The complaint also alleged that a 2023 U.S. Food and Drug Administration (FDA) inspection identified insanitary conditions at the facility. According to the complaint, the defendants voluntarily withdrew their registration to process FDA-regulated food in August 2023.

“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 Justice Department works closely with the FDA to pursue appropriate legal actions against food manufacturers who fail to adhere to laws designed to protect public health.”

“The FDA will continue to stress that it’s the responsibility of food manufacturers to ensure they are producing food under safe and sanitary conditions,” said Deputy Commissioner Jim Jones for Human Foods at the FDA. “When a company consistently fails to demonstrate that they are capable of upholding their legal responsibilities, the FDA will seek to hold them accountable.”

The defendants filed an answer denying the government’s allegations but agreed to settle the suit by entering into a consent decree. The order entered by the court permanently enjoins the defendants from violating the FDCA. The consent decree also requires, subject to limited exceptions, that the defendants notify the FDA and comply with specific remedial measures before resuming the manufacture of any FDA-regulated food products.

Trial Attorneys Colin W. Trundle and Kathryn A. Schmidt of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Sandra Lee Sears for the Eastern District of Louisiana handled the case, with assistance from Assistant Chief Counsel Sarah Rosenberg of FDA’s Office of the Chief Counsel.

The claims resolved by the consent decree are allegations only, and there has been no determination of liability.

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