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09/28/2015

FDA shuts down Miami company for non-compliance with GMPs

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SILVER SPRING, Md. - The Food and Drug Administration on Monday effectively shut down Sunset Natural Products for manufacturing and distributing adulterated dietary supplements, following a ruling Friday issued by U.S. Magistrate Judge Edwin  Torres for the U.S. District Court for the Southern District of Florida. Torres entered a consent decree of permanent injunction against the company and its two owners, Teresa Martinez and Elsy Cruz.


 


Under the terms of the consent decree, the company will not be allowed to manufacture or sell dietary supplement products until the FDA has determined that the business is in compliance with the Federal Food, Drug, and Cosmetic Act.  


 


“The FDA is committed to protecting the public health by ensuring dietary supplement makers operate in accordance with the law,” stated Melinda Plaisier, associate commissioner in the FDA’s Office of Regulatory Affairs. “Good Manufacturing Practice regulations are designed to safeguard consumers and violation of these requirements will result in enforcement action.”


 


The FDA issued Sunset Natural Products a Warning Letter on March 19, 2013, for violations of the cGMP requirements as well as unapproved drug claims. The FDA’s follow-up inspections in 2014 found that although the company removed drug claims from its products, it failed to bring its manufacturing operations into compliance with cGMP.


 


The consent decree prohibits the company and its owners from marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from the FDA to resume operations. 


 

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