Peregrina Cheese Inc. To Remain Open Under Consent Degree With FDA; Recalls Everything Its Made Since March 17, 2009

Brooklyn’s Peregrina Cheese Inc. and the U.S. Attorney for the Eastern District of New York have entered into a 16-page Consent Degree with many requirements---including the recall of all food products the company has distributed since March 17, 2009.

The Consent Degree was filed with the U.S. District Court for Eastern New York on Monday.

U.S. District Attorney Benton J. Campbell, representing the U.S. Food & Drug Administration, had asked the federal court to shut down the Peregrina Cheese factory at 342 Ten Eyck Street in Brooklyn.

FDA cited Peregrina’s problems with listeria contamination and inspections failures. The federal government also sought to bar Javier and Isabel Peregrina from the food business as individuals.

The Consent Degree requires Peregrina Cheese Inc. and the Peregrinas to:

  • Retain an independent laboratory to collect product and environmental samples.
  • Retain an independent sanitation expert to inspect the cheese factory and determine whether methods, facilities, and controls conform with federal law.
  • Require the sanitation expert and laboratory to review FDA and New York State findings since March 2003 and develop a written Listeria Monitoring Program.
  • Require reports and written document be provided to FDA.
  • Recall to the retail level all foods distributed since March 17, 2009.
  • Permits FDA to conduct all necessary inspections.
  • Requires Peregrina to pay all associated costs, including those incurred by FDA.

Assistant U.S. Attorney Seth D. Eiehenholtz represented the government and Arthur Morgan, Esq. represented the cheese-makers in the negotiations leading to the Consent Degree. 

Fate of Peregrina Cheese Now In Hands of A Federal Judge In Brooklyn

Senior Judge Frederic Block of the New York Eastern District, himself a Brooklyn native, will now decide what happens to Peregrina Cheese, Inc., (Peregrina Cheese), and two of its officers: Javier Peregrina and Isabel Peregrina.

Clearly, the U.S. Food and Drug Administration (FDA)  has run out of patience with Peregrina.   It went to Benton J. Campbell, U.S. District Attorney for Eastern New York, and Tony West, Assistant Attorney General for the Justice Department's Civil Division to get the full weight of the Justice Department behind FDA's threat to shut Peregrina down.

The Brooklyn cheese-maker has had its problems--troubles with inspections by both FDA and New York State; and the need for several recalls due to listeria contamination.  The government's complaint, 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.

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 the violations; and 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.

A consultant for Peregrina told a Brooklyn television station the company will fully defend itself as soon as the matter comes before Judge Block.  Dates already scheduled include a show cause hearing at 3 p.m., July 10th, and an initial conference at 10 a.m. on October 28, 2009.