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FDA orders Puerto Rican bakery to come clean or stay out of business

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Los Genuinos, Inc., a Bayamon, Puerto Rico, food manufacturer, has agreed under terms of a court order not to process or distribute food after FDA investigators found that the owner, Nicolas Rivera Berrios (and his company) “failed to “take effective measures to protect food against contamination from pests, adequately clean and sanitize equipment and utensils and properly store cleaning compounds away from food and manufacturing areas. In addition Los Genuinos did not accurately declare ingredients on product labels,” as required under Good Manufacturing Practice (cGMP) regulations.

Los Genuinos manufactures a variety of non-filled sweet bakery products and distributes these products locally to supermarkets, small grocery stores, general stores, pharmacies, bakeries and cafeterias.

“The company’s failure to correct these problems puts the health of consumers at risk, which is unacceptable,” said Melinda K. Plaisier, associate commissioner for regulatory affairs, FDA. “The FDA will continue to take enforcement action against firms that violate our manufacturing requirements.”

She also added that federal agents had conducted several inspections of the facilities during the fast few years and even sent a warning letter to Berriors in June 2011 after finding that bakery items had “been prepared, packed or held under unsanitary conditions and labels failed to declare a food allergen and unsafe color additive.”

Los Genuinos has now been ordered to hire an independent sanitation expert to help it come up with (and implement) a written sanitation control program, review all product labeling to ensure it complies with the Federal Food, Drug and Cosmetic Act and conduct an independent audit of the company’s operations and labeling before it will be allowed to go back into business.