News & Events
FDA NEWS RELEASE
For Immediate Release: July 7, 2009
Update: On July 20, 2009, Judge Frederic Block in the Eastern District of New York entered a consent decree of permanent injunction in this case. The defendants are now prohibited from processing and distributing food until they demonstrate to the FDA that their facility and processing equipment are suitable to prevent contamination in the food that they process, prepare, store, and handle. The defendants must, among other provisions in the consent decree, retain an independent laboratory to collect and analyze samples for the presence of Listeria, retain an independent sanitation expert, develop a program to control Listeria monocytogenes at their facility that is accessible to all employees in both English and Spanish, destroy all in-process and finished articles of food in the facility, and recall, to the retail level, all foods distributed since March 17, 2009, at their own expense. Under the consent decree, once the company resumes operations, the FDA may require the company to recall products or cease production if the Agency discovers future violations.
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FDA Takes Enforcement Action Against Cheese Manufacturer
Company failed to correct violations despite being advised by federal officials to do so and fines by state officials
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, today filed a complaint seeking injunctive relief against Peregrina Cheese, Inc., (Peregrina Cheese), Brooklyn, N.Y. and two of its officers: Javier Peregrina and Isabel Peregrina.
The company prepares and processes a variety of cheeses, sour cream, flan and gelatin products and distributes them to specialty grocery stores in northeastern Pennsylvania and in the New York City area.
The government's complaint, filed today in the Eastern District of New York, alleges that the company has an extensive history of operating under insanitary conditions and producing cheese contaminated with Listeria monocytogenes. Listeria is a foodborne pathogen that can cause serious illness and death.
If entered by the court, the injunction would temporarily stop the company and its officers from manufacturing and distributing food until further action is taken by the court.
“This company has consistently failed to make corrections to improve the insanitary conditions under which it processes cheese products, despite frequent warnings to do so,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The FDA will not tolerate food companies that fail to provide adequate safeguards.”
"When called upon by the FDA, the Department of Justice is ready and able to prevent the distribution of adulterated food to American consumers," said Tony West, Assistant Attorney General for the Justice Department's Civil Division.
“The public must be able to trust that the food in their grocery stores is safe for them to eat,” said Benton J. Campbell, the United States Attorney for the Eastern District of New York. “We will continue to work with the FDA to ensure that companies that produce food under dangerous or insanitary conditions take corrective action to clean up their act.”
As alleged in the complaint, on numerous occasions since 2004, FDA investigators found Listeria monocytogenes in finished cheese products and inside Peregrina Cheese’s facility. Additionally, routine laboratory testing by New York State Department of Agriculture and Markets (NYSDAM) also found Listeria in the company’s products on numerous occasions since 2003.
The FDA and NYSDAM inspections also revealed that the company repeatedly violated the current Good Manufacturing Practice (cGMP) requirements for foods. Investigators found filthy conditions, standing water in food processing equipment, workers inappropriately dressed and a dead rodent inside the plant.
The government’s complaint alleges that both the FDA and NYSDAM repeatedly advised Peregrina Cheese and its officers of their cGMP violations; NYSDAM has also assessed fines against the company.
Peregrina Cheese’s lack of effective measures to bring its food processing operations into compliance with the law poses a public health threat because of the potential that Listeria will be in the food processed by the company.
Listeriosis, the illness caused by Listeria monocytogenes, can be serious and sometimes cause fatal infections in young children, frail or older people, and others with weakened immune systems. Although healthy individuals may experience only short-term symptoms, such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection in pregnant women can cause miscarriages and stillbirths.
No illnesses have been reported to date from Peregrina Cheese products. However, if individuals have eaten the products and are experiencing any of the symptoms listed above, they should contact their health care professional.
Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.