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Monday, June 17, 2024 | Back issues
Courthouse News Service Courthouse News Service

Court Orders Pill Maker to Fix Factory Processes

(CN) - A federal judge in Florida has issued a permanent injunction against Sunset Natural Products over alleged violations related to the identity, purity and composition of its dietary supplements.

The U.S. Department of Health and Human Service and the U.S. Attorney's Office in Miami, sued Sunset Natural Products and its principals in early September, alleging the company's supplements were "prepared, packed, or held" in variance with "current manufacturing regulations."

Compliance with these rules -- a set of controls in the design and production process -- "ensure[s] a finished product of acceptable, predictable and reliable quality," the complaint says.

Inspections by the FDA allegedly determined that Sunset failed to perform appropriate tests and examinations to verify the identity of every dietary ingredient; to establish specifications for the identity, purity, strength and composition of the final products; and to use equipment and utensils of appropriate design, construction and workmanship in order to keep them clean and properly maintained.

After assessing the inspections, the FDA warned Sunset's owners Teresa Martinez and Elsy Cruz about the deviations, and an inspector gave them a "List of Inspectional Observations" detailing the many violations committed against the Federal Food, Drug and Cosmetic Act, the complaint says.

The complaint claims that on March 19, 2013, the FDA issued a warning letter to Martinez stating that it was their responsibility "to ensure compliance with the Act and its implementing regulations and cautioned that failure to take prompt action to correct the deviations, and prevent their recurrence, may result in legal action including an injunction."

Both Martinez and Cruz sent letters to the FDA "promising to take corrective action" in response to the observations and warnings. However, they did not follow their promises, the complaint says.

In granting the government's request for injunctive relief, U.S. District Judge Edwin Torres ordered the defendants to hired an independent inspector at their expense to perform a comprehensive evaluation of Sunset Natural Products' manufacturing facility and its manufacturing and logistics processes.

That inspector will then be required to submit a report of his findings to the Food and Drug Administration, and in the meantime, Sunset Natural Products will conduct a recall and destroy all supplements it manufactured between April 2, 2014 and Sept. 10, 2015, Torres said.

Representatives of Sunset Natural Products Inc. did not respond to a request for comment from Courthouse News.

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