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FDA Closes Tortilla Plant

Unsanitary conditions found at Chicago company's plant

March 9, 2009

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A tortilla company linked to several outbreaks of gastrointestinal illness in school children is now shut down under action taken by the Food and Drug Administration (FDA).

FDA officials entered into a consent agreement Friday with the Chicago Del Rey Tortilleria Inc., its president, and two general managers that prevents the company from making or distributing soft-shell flour tortillas until it corrects multiple sanitation violations.

The FDA said its enforcement action comes on the heels of the company’s “extensive history” of violating the agency's Good Manufacturing Practice (cGMP) requirements for food.

The FDA’s complaint alleges the company’s manufacturing operations do not adequately protect consumers against the risk of contamination.

“We cannot allow a company to produce potentially contaminated products because of failing to have adequate procedures in place,” Michael Chappell, acting associate commissioner for regulatory affairs at FDA, said in a written statement. “This enforcement action shows the FDA will take the appropriate measures deemed necessary under the Federal Food, Drug and Cosmetic Act to protect the public's health.”

When FDA officials inspected the company’s Illinois plant, they discovered cleaning chemicals stored improperly, unsuitable containers used for food processing, and other unsanitary conditions.

The FDA’s complaint stated flour tortillas made by the company were associated with several outbreaks of gastrointestinal illness in school children, which triggered a recall of the products.

Under the FDA’s action, the company must hire sanitation and food processing experts to develop quality control measures. These experts will also inspect and certify the company complies with FDA regulations and meets other consent decree requirements.

The company cannot start making and distributing tortillas until the FDA inspects the facility and determines it is in compliance with the consent decree and other federal food and safety regulations. If the company fails to comply with the consent decree, the FDA could order it to stop making and distributing food, recall its products, or to take other corrective actions. The company could also face fines of $6,000 per day for being non-compliant.

Consumers who have food safety questions about these or other products can call the FDA's toll-free Food Safety Hotline at (888) SAFEFOOD. They can also report any problems to the www.fda.gov/opacom/backgrounders/complain.html FDA’s consumer complaint coordinator in their area.

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