04.01.13
A federal judge has ordered a California company and its owner to stop manufacturing and distributing drugs and dietary supplements in domestic commerce until its manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act.
The court found that Titan Medical Enterprises Inc., of Santa Fe Springs, CA, and James McDaniel, Titan Medical’s owner and president, violated the act by failing to follow current Good Manufacturing Practices (GMPs) for drugs and dietary supplements. The court also found 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.
Nine FDA inspections of Titan between 2001 and 2012 revealed that the company’s drugs were not manufactured and distributed in compliance with drug GMPs. 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 court found that Titan Medical Enterprises Inc., of Santa Fe Springs, CA, and James McDaniel, Titan Medical’s owner and president, violated the act by failing to follow current Good Manufacturing Practices (GMPs) for drugs and dietary supplements. The court also found 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.
Nine FDA inspections of Titan between 2001 and 2012 revealed that the company’s drugs were not manufactured and distributed in compliance with drug GMPs. 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.