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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

FDA resolves criminal and civil actions against cheese manufacturer

Delaware-based cheese manufacturer Roos Foods, Inc. has pleaded guilty to one criminal misdemeanor count of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) by introducing adulterated food into interstate commerce.

The company and two co-owners, Ana A. Roos and Virginia Mejia, have also entered into a civil agreement called a consent decree of permanent injunction. According to that decree, if Roos Foods or the two individuals want to begin producing and distributing food in the future, they can do so only if the FDA confirms that their operations comply with the FD&C Act and all applicable food safety regulations.

Roos Foods, Inc. made ready-to-eat cheeses such as ricotta, queso fresco and fresh cheese curd, and had customers in Delaware, Maryland, New Jersey, New York, Virginia, and Washington, D.C. The Virginia Department of Agriculture and Consumer Services, Maryland Department of Health and Mental Hygiene, District of Columbia Department of Health, and Delaware Division of Public Health worked closely with the FDA during this investigation.

Cheese produced by Roos Foods, Inc. was linked to an outbreak of Listeria monocytogenes (L. mono) that sickened eight people in 2013. Seven people were hospitalized.

The FDA suspended Roos Foods, Inc.’s facility registration on March 11, 2014, which barred the company from introducing food into interstate commerce. The agency’s order of suspension details sanitation problems and cites findings of L. mono contamination in multiple places in the facility.

“The FDA will not tolerate food companies that fail to provide adequate safeguards and place the public health at risk by producing and shipping contaminated products,” said the FDA’s Deputy Commissioner for Global Regulatory Operations and Policy Howard Sklamberg. “We will continue to work with the Department of Justice to use the full force of our justice system against those that place profits over the health and safety of American consumers.”

“We must work to ensure that the food we buy is free from dangerous bacteria and is safe to eat,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division.  “The Department of Justice will continue to work aggressively to combat and deter conduct leading to the distribution of adulterated food to consumers.”