FDA acts to prevent contamination problems with Triad products
US Marshals Service seizes drug products manufactured and distributed by Wisconsin firms
The US Food and Drug Administration seized more than US$6m in products made by Triad Group and H&P Industries to prevent the distribution of products that might be contaminated and pose a health risk.
At the FDA’s request, US Marshals Service deputies seized products from the company’s facility in Hartland, Wisconsin. The drug products included povidone-iodine and benzalkonium chloride antiseptic products, cough and cold products, nasal sprays, suppositories, medicated wipes, antifungal creams, haemorrhoidal wipes, in-process drug products, and raw materials.
Triad Group and H&P Industries are owned and managed by the same parties. H&P, which makes alcohol wipes and other products distributed by Triad, has been under investigation by the FDA for bacterial contamination issues.
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 said.
The agency’s most recent inspection found multiple violations of cGMP requirements, including continuing problems with the air handling system and failures of quality control.
“We took this action to stop Triad from continuing to distribute products, which may pose a risk to public health,” said Dara Corrigan, FDA associate commissioner for regulatory affairs.
H&P Industries voluntarily shut down production after the US Marshals Service deputies arrived to seize the products.
The move follows “the continued failure” of the companies to comply with the FDA's current good manufacturing practice (cGMP) regulations, the FDA said.
