Federal regulators take legal action against wipes maker

Federal regulators take legal action against wipes maker
Updated 35m ago

Federal regulators have taken legal action to bar a Wisconsin company from making or distributing its health care products, following five recalls of disinfectant wipes and other health care products.

The Food and Drug Administration said Monday that federal prosecutors filed a legal injunction against the Triad Group and H&P Industries of Hartland, Wisconsin. Once it takes effect, the court order will prohibit the company from resuming manufacturing until its operations have been shown to meet federal quality standards.
Triad's products were widely used in medical facilities around the country, and were available for sale to the public at Safeway, City Market and Walgreen's chain stores.
Since December, the group has issued five voluntary recalls, including two because of bacterial contamination found in its products, according to the FDA. Triad Group sells antibacterial wipes, cough and cold medicines, nasal sprays and other products.
FDA inspectors have uncovered a series of quality control issues at the company's Hartland factory since 2009. The most recent inspection in March found a number of problems, including problems with a ventilation system and a failure to investigate drug quality issues. In April, U.S. marshals seized $6 million worth of products from the company's Wisconsin headquarters.
Triad Group and H&P Industries are owned and managed by the same parties.
Triad, a private company, said it has reached an agreement with the FDA to hire an outside consultant to review its operations. The company can resume operations once the consultant and the FDA have certified that the company meets federal guidelines. H&P and Triad will likely operate under federal supervision for at least five years after resuming production, according to the company.
"We are fully committed to addressing FDA's concerns and rebuilding the confidence of the customers we have served for so many years," said H&P president Eric Haertle, in a statement.
An FDA spokeswoman said U.S. prosecutors filed the order in court Friday. It will take effect after it has been signed by a judge.

http://yourlife.usatoday.com/health/story/2011/06/Federal-regulators-take-legal-action-against-wipes-maker/48361988/1?dlvrit=205764