Tortilla Manufacturer Shut Down by FDA for Repeat ViolationsMar 9, 2009 | Parker Waichman LLP
Del Rey Tortilleria Inc. of Chicago, Illinois has been shut down by a U.S. Food and Drug Administration (FDA) enforcement action following what the FDA described as an “extensive history” of Del Rey Tortilleria violating FDA’s current Good Manufacturing Practice (cGMP) for food. The FDA said that the consent decree of permanent injunction has been entered for Del Rey Tortilleria, its president, and two general managers and prohibits Del Rey Tortilleria from manufacturing and distributing soft-shell flour tortillas until the company obtains FDA approval. Del Ray Tortillas were recalled on several occasions after they were implicated in food poisoning incidents.
The complaint was filed by the United States Attorney in Chicago and alleges that Del Rey Tortilleria'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," said Michael Chappell, acting associate commissioner for regulatory affairs at FDA. "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," he added, according to the FDA release.
The FDA said that inspections at the Illinois plant turned up a variety of violations, including cleaning chemicals stored improperly, unsuitable containers used for food processing, and other unsanitary conditions. The complaint states that Del Rey Tortilleria flour tortillas made at the Illinois plant were linked with a number of gastrointestinal illness in school children, which resulted in at least one product recall by Del Rey Tortilleria.
In November 2007, a recall was issued after scores of Wisconsin students became ill after eating Del Rey products and included products distributed nationwide. Also that month, the Racine Unified School District closed two middle schools and an elementary school for one day after 80 children fell ill. Wisconsin health officials said the recalled Del Rey flour tortillas were served at all three schools. All of the children exhibited flu-like symptoms including vomiting, nausea, and abdominal cramping.
At the time, Del Rey insisted that the flour tortilla recall was only a precaution; however, that recall was not the first Del Rey had to issue following a mysterious outbreak of food borne illness. In January 2006, Del Rey recalled four varieties of flour tortillas after they were suspected of making people sick and were linked to an illness outbreak in December 2005 that sickened 53 students and three staff members at five middle schools in Illinois. People stricken in that outbreak also complained of stomach pains, vomiting, diarrhea, nausea, and headaches. Also, lab results following a 2003 outbreak in Massachusetts found elevated levels of two chemical additives used in the production of Del Rey tortillas—potassium bromate and calcium propionate. The levels were elevated compared to common industry practices, according to the Centers for Disease Control (CDC). Another outbreak associated with flour tortillas occurred in Iowa that September.
Now, Del Rey Tortilleria must hire sanitation and food processing experts to develop quality control measures and to inspect and certify that it complies with the FDA’s cGMP and meets other consent decree requirements, said the agency. And, the defendants may only resume manufacturing and distributing soft-shell flour tortillas after the FDA inspects the facility and determines that the defendants are in compliance with the decree, cGMP, and the Federal Food, Drug & Cosmetic Act. Failure to comply could result in the FDA ordering the defendants to stop manufacturing and distributing food, to recall products, or to take other corrective actions, including ordering the defendants to pay $6,000 per day for noncompliance.