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FDA Suspends Registration of Cheese Manufacturer Over Health Risk

For the second time since gaining the authority to do so, the U.S. Food and Drug Administration on Thursday suspended the registration of a food facility – this time Roos Foods Inc., the maker of cheese and sour cream that caused an outbreak of Listeria in Maryland and California that included one death.

The facility’s registration was suspended after FDA determined there was still a reasonable probability that food manufactured by Roos could pose a public health threat.

Without FDA registration, Roos will be unable to ship food to retailers or sell any products.

FDA inspected the company’s facility between Feb. 18 and March 4, finding a number of “insanitary conditions,” including a roof leaking so badly that water was raining down onto equipment and storage tanks in the cheese processing room. Inspectors also found standing water in processing rooms, metal roofs with flaking rust, and food residue left on equipment after cleaning had been performed.

“FDA has determined that food manufactured, processed, packed, received, or held by your facility has a reasonable probability of causing serious adverse health consequences or death to humans, and that your facility created, caused, or was otherwise responsible for such reasonable probability,” the agency wrote in a letter to the company.

The suspension will be lifted when Roos Foods can demonstrate that the conditions at its facility no longer have a “reasonable probability” of threatening public health.

The Roos Foods Listeria outbreak has been connected to seven hospitalizations in Maryland and one death in California. Five of the illnesses involved a pregnancy: two sickened mother-newborn pairs and an additional sickened newborn.

The company previously recalled all lots of the following cheese products:

  • Mexicana:
    • Cuajada En Terron
    • Cuajada/Cuajadita Cacera
    • Cuajada Fresca
    • Queso Fresca Round
    • Queso Dura Viejo Hard Cheeses
  • Amigo:
    • Cuajada En Terron
    • Cuajada/Cuajadita Cacera
    • Cuajada Fresca
    • Queso Fresca Round
    • Queso Dura Viejo Hard Cheeses;
  • Santa Rosa De Lima:
    • Cuajada En Terron
    • Cuajada/Cuajadita Cacera
    • Cuajada Fresca
    • Queso Fresca Round
    • Queso Dura Viejo Hard Cheeses
  • Anita Queso Fresco

The company has also recalled its Crema Pura Mexicana Cultured Sour Cream.

The products are packaged in flexible plastic bags and rigid plastic clam shell packages in 12 oz. and 16 oz. sizes under the brand names: Mexicana, Amigo, Santa Rosa De Lima, and Anita. They were distributed in Maryland, Virginia and Washington, D.C, through retail stores.

FDA acquired the ability to suspend registrations and therefore block products from commerce as part of the Food Safety Modernization Act, signed into law in 2011.

This is the second time FDA has used its power to suspend a food facility’s registration. The agency’s authority was first used on Sunland Inc., formerly the nation’s largest manufacturer of organic peanut butter, after its peanut butter products were linked to a national Salmonella outbreak.

© Food Safety News
  • crs

    About time!

  • Jim in NJ

    Gotta keep an eye out for “insanitary conditions”. Is that the cause of mad cow?