Court shuts down U.S. operations of Titan Medical Enterprises
A federal judge has ordered Titan Medical Enterprises, a Santa Fe Springs, Calif.-based manufacturer, and its owner, James L. McDaniel, to stop manufacturing and distributing drugs and dietary supplements in domestic commerce until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act.
The court found that the company and McDaniel violated the Act by failing to follow current Good Manufacturing Practice (GMP) for drugs and for dietary supplements. The court also found that the defendants violated federal law by distributing unapproved new drugs in violation of the Act. Prior to entry of the court’s order, Titan Medical Enterprises manufactured and domestically distributed a variety of drugs and dietary supplements.
“The FDA continues to take strong enforcement actions against companies that fail to comply with federal drug and dietary supplement manufacturing regulations,” said Melinda K. Plaisier, acting associate commissioner for regulatory affairs. “The actions we are taking are necessary to make sure that the drugs and dietary supplements consumers purchase have been manufactured in compliance with cGMP."
Nine FDA inspections of Titan between 2001 and 2012 revealed that the company’s drugs were not manufactured and distributed in compliance with Drug cGMP. Violations included failure to establish an adequate written testing program to assess the stability of finished products and failure to establish and follow adequate laboratory controls.
The Dietary Supplement cGMP regulations went into effect in 2007 and became effective over the following three years based on company size. Titan’s compliance date was in 2010, and FDA inspections in 2010, 2011 and 2012 revealed that Titan violated the Dietary Supplement cGMP regulations by, among other things, failing to verify that a subset of finished dietary supplement batches met product specifications and failing to adequately confirm the identity of dietary supplement components.