A federal judge has ordered Titan Medical Enterprises of Santa Fe Springs, California to shut down in response to a complaint filed by the U.S. Justice Department, on behalf of the FDA. The facility must stop manufacturing and distributing drugs and dietary supplements until their operations comply with the Federal Food, Drug, and Cosmetic Act.
The court found that the company “failed to follow current Good Manufacturing Practice for drugs and for dietary supplements (Dietary Supplement cGMP). Unapproved new drugs were used in the supplements in violation of the Act. Associate Commissioner for Regulatory Affairs Melinda K. Plaisier said, “the FDA continues to take strong enforcement actions against companies that fail to comply with federal drug and dietary supplement manufacturing regulations.”
The Titan facility violated the Dietary Supplement cGMP, which went into effect in 2007, in 2010, 2011, and 2012. The company failed to verify that some of their finished dietary supplement batches met product specifications and failed to confirm the identity of dietary supplement components.
