Californian Drug and Dietary Supplement Manufacturer Closed

 Posted on March 18, 2013 in Defective Medical Devices

According to the FDA, a federal judge declared that a Californian company must stop manufacturing drugs and dietary supplements for domestic commerce—at least until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act.

Titan Medical Enterprises, Inc. continuously failed to comply with Good Manufacturing Practice for drugs or Good Manufacturing Practice for dietary supplements. In addition, the company violated the Act by distributing unapproved new drugs.

Between 2001 and 2012, Titan Medical Enterprises, Inc. had been inspected by the FDA nine times and was found to be in violation of the Good Manufacturing Practice for drugs by failing to establish an adequate written testing program to assess the stability of finished products and failing to establish and follow adequate laboratory controls. The owner, James L. McDaniel, was given written notice in 2003 about the violations.

In 2007, the Good Manufacturing Practice for dietary supplements went into effect. Based on the company's size, the regulations were to be put into practice throughout the next three years. In 2010, 2011, and 2012, the FDA found Titan Medical Enterprises, Inc. to not be in compliance with various parts of the Act. These violations included 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.

The order was signed by U.S. District Judge Otis D. Wright in December of last year.

The FDA was set up to protect the public's health, but sometimes products may slip through the initial cracks. If you have used a recalled product or had complications from any drugs or dietary supplements, you may be entitled to compensation. Our law firm has multiple locations throughout Northern Illinois and has over 40 years combined experience in defective medical device and product law. Talk to a knowledgeable lawyer today to see if you have a case.