FDA acts to prevent contamination problems with Triad antiseptic products
SILVER SPRING, Md. — U.S. marshals have seized more than $6 million in products distributed by Triad Group at the company’s facility in Hartland, Wis., the Food and Drug Administration reported Wednesday.
“We took this action to stop Triad from continuing to distribute products [that] may pose a risk to public health,” stated Dara Corrigan, FDA associate commissioner for regulatory affairs.
A variety of drug products were seized, including povidone-iodine and benzalkonium chloride antiseptic products, cough-cold products, nasal sprays, suppositories, medicated wipes, antifungal creams, hemorrhoidal wipes, in-process drug products and raw materials.
The action follows the continued failure of H & P Industries — owned and managed by the same party as Triad Group — to comply with the FDA’s current good manufacturing practice regulations.
Since December 2010, H & P Industries has initiated three voluntary product recalls due to various types of bacterial contamination found in the products.
The FDA completed its most recent inspection of H & P Industries on March 28. The inspection found multiple violations of cGMP requirements, including continuing problems with the air handling system, failure to adequately investigate drug products that did not meet specifications affecting the majority of the products manufactured at the facility and failure to take the proper measures to ensure the quality of incoming components.