CHICAGO — The Food and Drug Administration has sued Chicago-based Del Rey Tortilleria Inc., alleging the company used operations that do not adequately protect consumers against the risk of contamination. In response to the complaint, Del Rey, its president, and two general managers have entered into a consent decree of permanent injunction that prevents Del Rey Tortilleria from manufacturing and distributing soft-shell flour tortillas until the company obtains F.D.A. approval.
The F.D.A., which has vowed to ramp up its food safety focus following several Salmonella outbreaks in recent years, said its action follows Del Rey’s extensive history of violating the F.D.A.’s current Good Manufacturing Practice (cGMP) requirements for food.
"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 the F.D.A. "This enforcement action shows the F.D.A. will take the appropriate measures deemed necessary under the Federal Food, Drug and Cosmetic Act to protect the public’s health."
During F.D.A. inspections, the agency said it found several violations, including cleaning chemicals stored improperly, unsuitable containers used for food processing, and other unsanitary conditions inside the Chicago plant. According to the complaint, flour tortillas manufactured by Del Rey Tortilleria were associated with several outbreaks of gastrointestinal illness in school children, resulting in a product recall by the company.
Before Del Rey Tortilleria is allowed to start making flour tortillas the company must hire sanitation and food processing experts to develop quality control measures and inspect and certify that the company complies with cGMP and meets other consent decree requirements. The defendants may resume manufacturing and distributing soft-shell flour tortillas only after the F.D.A. inspects the facility and determines that the defendants are in compliance with the decree, cGMP, and the Federal Food, Drug & Cosmetic Act, the F.D.A. said.
If Del Rey Tortilleria fails to comply with the consent decree the F.D.A. may order the company to stop manufacturing and distributing food, to recall products or to take other corrective actions. In addition, the defendants may be ordered to pay $6,000 per day for being non-compliant.