Supplement Manufacturer Closed Over GMP Violations

LOS ANGELESFDA has shut down a California-based manufacturer of drugs and dietary supplements after repeated violations of both drug and supplement good manufacturing practices (GMPs). Federal Judge Otis D. Wright II, of the Central District of California, ordered Santa Fe Springs, Calif.-based Titan Medical Enterprises Inc. and its owner James L. McDaniel to stop manufacturing and distributing its drug and dietary supplement products until it complies with federal regulations for food, drug and supplement manufacturing.

FDA identified drug GMP 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 Melinda K. Plaisier, associate commissioner for regulatory affairs at FDA. 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."

FDA's warning letter to Titan Medical Enterprises Inc.