Puerto Rico bakery agrees to stop manufacturing and distributing products
For Immediate Release: April 16, 2014 Media Inquiries: Juli Putnam, 240-402-0537, juli.putnam@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA
Puerto Rico bakery agrees to stop manufacturing and distributing products
Los Genuinos, Inc., a Bayamon, Puerto Rico, food manufacturer, has agreed under terms of a court order not to process or distribute food until it addresses the unsanitary conditions found by U.S. Food and Drug Administration investigators. The company must also correct its product labels to accurately reflect the ingredients used in its products.
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.
Los Genuinos and its owner, Nicolas Rivera Berrios, have failed to adequately implement corrective and preventive actions to address current Good Manufacturing Practice (cGMP) requirements and labeling violations.
The companys 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.
During the FDAs most recent inspection, agency investigators found that Los Genuinos had 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. Investigators also observed that Los Genuinos did not accurately declare ingredients on product labels.
Before it will be allowed to resume operations, Los Genuinos must hire an independent sanitation expert to help the company develop 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 companys operations and labeling.
For more information:
Your Guide to Reporting Problems to the FDA
Warning letter to Los Genuinos, Inc., June 2, 2011
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