CHICAGO — The United States today obtained an agreed permanent injunction against a Chicago food processing firm, Triple A Services Inc., and three of its executives after filing a federal lawsuit alleging that Triple A’s ready-to-eat sandwiches and produce were not being prepared in compliance with federal regulations to protect food against contamination. A consent decree approved today by U.S. District Judge William J. Hibbler prevents the company from distributing any food products, except those that are pre-packaged when they enter its facility and leave in the same unwrapped condition, until it obtains approval from the Food and Drug Administration (FDA), which initiated the enforcement action.
Triple A Services prepares, processes, packs and distributes ready-to-eat food products that are sold to the public, including through mobile catering services. Also named as defendants were Triple A executives Thomas J. Whennen, chief executive officer; Scott C. Whennen, president; and David A. Frisco, general manager.
The lawsuit and decree were announced by Tony West, Assistant Attorney General for the Civil Division and Patrick J. Fitzgerald, U.S. Attorney for the Northern District of Illinois.
The FDA is not aware of any illnesses that have occurred as a result of the allegedly contaminated food products.
The lawsuit, also filed today, alleges violations of the Federal Food, Drug and Cosmetic Act and was brought on behalf of the FDA after its investigators found evidence of violations over the course of inspections between July 6 and Aug. 24, 2011, as well as during previous inspections since 2001. At the conclusion of the August 2011 inspection, FDA provided the firm with notice of deficiencies which needed correction. The most recent inspection revealed the presence of Listeria monocytogenes (L. Monocytogenes or L. mono) in the facility. Inspections in 2001 and 2002 also revealed the presence of L. mono in the facility. L. mono is of particular concern with respect to ready-to-eat products such as those produced by Triple A. It can cause the disease listeriosis, which is serious and even fatal in high-risk groups such as infants, the elderly and persons with impaired immune systems.
The company and its officials have agreed, without further litigation, to cease distribution of certain products until FDA approval is obtained and for agreeing to take other measures such as hiring sanitation and food processing experts to remedy certain deficiencies in its manufacturing process before resuming food processing operations.
“The violations FDA uncovered in this case posed health and safety risks to consumers,” said Assistant Attorney General West. “Companies that process the food we eat must comply with the rules that keep us safe or face being shut down.”
According to the lawsuit, Triple A was in violation of the FDA’s current “good manufacturing practice” regulations, which specify methods and controls that food processors like Triple A must follow to ensure that their products do not present a potential threat to public health. During inspections over a 10-year period, the FDA found, among other things, that Triple A did not have a written plan for handling seafood products, stored food improperly, failed to eradicate a pest problem, did not fix water leakage problems, and did not address employee cleanliness issues. Both the presence of L. mono in Triple A’s facility and the company’s failure to comply with the regulations renders all food products produced under those conditions in the facility adulterated under the Federal Food, Drug, and Cosmetic Act.
To obtain FDA approval to resume food processing operations, Triple A and its sanitation and food processing experts must demonstrate to FDA’s satisfaction that it has corrected the L. Mono and other problems in its facility and has instituted procedures to ensure that there will be no recurrence of those or any other problems that could present a threat to public health. If the defendants fail to comply with the consent decree, the FDA may order them to stop manufacturing and distributing food, recall products, or take other corrective action. The defendants could also be ordered to pay $2,500 per day if they fail to comply with the decree.
Consumers with food safety questions may call the FDA’s toll-free Food Safety Hotline at 888-SAFEFOOD (888-723-2366), and any problems may be reported to the FDA consumer complaint coordinator in their geographic area. Contact numbers may be found at www.fda.gov/opacom/backgrounders/complain.html .
The government is being represented by Assistant U.S. Attorney Donald Lorenzen in the Northern District of Illinois and Trial Attorney Carol Wallack of the Department of Justice’s Consumer Protection Branch.