U.S. District Judge Otis D. Wright of the Central District of California has ordered Titan Medical Enterprises Inc., of Santa Fe Springs, CA., and its owner/president 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 Act).
FDA identified drug GMP (Good Manufacturing Practice) violations over the course of nine inspections of Titan between 2001 and 2012. Problems 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. FDA also inspected Titan's dietary supplement manufacturing in 2010, the date when the company's size required its compliance, as well as in 2011 and 2012.
Among the supplement GMP violations discovered were 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. In addition to non-compliance with GMPs for both drugs and supplements, the defendants were found in violation of federal law by distributing unapproved drugs.
“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."
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.