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Posted February 12, 2013

Judge Orders Drug and Supplement Company to Cease Manufacturing and Distribution

On February 8, 2012, the FDA announced Titan Medical Enterprises Inc. has been ordered to stop manufacturing and distributing drugs and dietary supplements until the company's manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act. The order was signed on December 11, 2012, U.S. District Judge Otis D. Wright of the Central District of California.

(The summary judgment, signed by the same judge on February 4, 2013, can be read here.)

The U.S. Department of Justice filed a complaint on behalf of the FDA after numerous FDA inspections found the company had not complied with Current Good Manufacturing Practices (cGMPs) for drugs or supplements.

Nine FDA inspections between 2001 and 2012 found the company's drugs were not in compliance with Drug cGMPs.

Inspections in 2010, 2011, and 2012 found Titan to be in violation of Dietary Supplement cGMPs. Like other companies of its size, Titan was given three years to become compliant with new federal dietary supplement regulations which went into effect in 2007.

Titan's violations of Dietary Supplement cGMPs include 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.

While specific Titan products were not identified in the FDA's announcement, the company did receive a warning letter in 2003 for marketing its Rad Block KI potassium iodide dietary supplements as "radiation-blocking tablets."

See's Review Article on Potassium Iodide (KI) and Potassium Iodate (KIO3): Radioprotective Agents for more information on related products.

See Related Warnings:

FDA Warns Laboratory of Manufacturing Violations

FDA Seeks Permanent Injunction Against Dietary Supplement Maker -- 400+ Products Affected

Court Closes the Doors on Company That Sold Weight Loss Supplement

For more information about the order, use the link below.