U.S. District Judge Otis D. Wright of the Central District of California signed the order on Dec. 11, 2012, against Titan Medical Enterprises Inc., of Santa Fe Springs, CA, and James L. McDaniel, Titan Medical’s owner and president. The order was entered in response to a complaint filed by the U.S. Department of Justice, on behalf of the FDA.
The court found that the company and McDaniel violated the Act by failing to follow current Good Manufacturing Practice for drugs (Drug cGMP) and for dietary supplements (Dietary Supplement cGMP). 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 acting associate commissioner for regulatory affairs, Melinda K. Plaisier. “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.
Drug cGMP includes practices and systems required to be adopted in the manufacture and testing of pharmaceuticals. Drug cGMP outlines the aspects of production and testing that can impact the quality of a product.
Similarly, Dietary Supplement cGMP regulations require dietary supplement manufacturers to ensure quality in their dietary supplements by appropriately controlling all aspects of their processes and procedures to ensure a supplement meets minimal quality standards and is not adulterated by the presence of contaminants.