The U.S. Department of Justice filed a complaint on behalf of the FDA after the Sante Fe Springs company, and its owner and president, and James L. McDaniel, were alleged to have violated Federal Food, Drug, and Cosmetic Act by failing to follow current Good Manufacturing Practice for drugs (Drug cGMP) and for dietary supplements (Dietary Supplement cGMP).
U.S. District Judge Otis D. Wright of the Central District of California signed the order on Dec. 11, 2012.
According to the FDA , 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.
Dietary supplement cGMP regulations came into effect in 2007 and, because of the size of the company, Titan’s compliance date was in 2010. 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.
Acting Associate Commissioner for Regulatory Affairs Melinda 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 actions we are taking are necessary to make sure that the drugs and dietary supplements consumers purchase have been manufactured in compliance with cGMP."