US Enters Consent Decree with Dietary Supplement Manufacturer

The company entered the consent decree due to its repeated failure to follow current good manufacturing practices, according to FDA.

The United States has entered a consent decree with Triceutical, Inc., a dietary supplement manufacturer based in New York, according to a report from the U.S. Food and Drug Administration. The company's repeated failure to follow good manufacturing practices prompted government action, and the company's president has agreed to stop production and distribution of products due to its violations of the Current Good Manufacturing Practice (cGMP) requirements. The consent decree was officially entered by U.S. District Judge Leonard D. Wexler of the Eastern District on July 8.

FDA will be supervising the company's subsequent recall and destruction of all dietary supplements that were manufactured, prepared, packed, repacked, labeled, held, and distributed since Feb. 6, 2012. The company must bring its manufacturing, packing, repacking, and labeling procedures into compliance with FDA laws and regulations before it can resume production and distribution.

FDA initially issued a warning letter to the company on Nov. 8, 2012. It cited various violations, such as the company's failure to perform tests to verify the identity of dietary ingredients used to manufacture the dietary supplements. FDA's follow-up inspections showed the company failed to take adequate corrective action, rendering the company's products "adulterated under the Federal Food, Drug, and Cosmetic Act," according to FDA.

"When a company violates good manufacturing practice requirements, they put consumers at risk," said Melinda K. Plaisier, FDA's associate commissioner for regulatory affairs. "Our goal at the FDA is to ensure that the dietary supplements consumers have access to meet federal standards for safety, effectiveness and quality."

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