FDA shuts down Long Island company for non-compliance to dietary supplement cGMPs

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday shut down a company for noncompliance of the dietary supplement current good manufacturing practice requirements. 

 

"Triceutical of Farmingdale, New York, and Liqun Zhang, the company’s president, have agreed to stop production and distribution of dietary supplements under the terms of a consent decree because of violations of federal dietary supplement regulations," the agency stated. "Triceutical, under the FDA’s supervision, is required to recall and destroy all dietary supplements that were manufactured, prepared, packed, repacked, labeled, held and/or distributed since Feb. 6, 2012, in accordance with the procedures in the consent decree. The consent decree was entered by U.S. District Judge Leonard Wexler of the Eastern District on July 8, 2014."

 

The FDA issued Triceutical a warning letter dated Nov. 8, 2012, that outlined serious violations of cGMP requirements, including failure to perform tests to verify the identity of dietary ingredients used to manufacture the dietary supplements. Follow-up inspections by the FDA revealed that Triceutical failed to take adequate corrective actions to correct that violation and to ensure the manufacturing process complied with cGMP requirements. Failure to follow cGMP requirements made Triceutical’s products adulterated under the Federal Food, Drug and Cosmetic Act.

 

“When a company violates good manufacturing practice requirements, they put consumers at risk,” stated Melinda Plaisier, the 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."