Decree filed by U.S Attorney's office, Dept. of Justice, would prevent Wisc. firm from making, distributing products
Federal officials on Friday sought a permanent injuction against the Wisconsin firm accused of making and distributing medical products potentially tainted with life-threatening bacteria, a spokeswoman for the Food and Drug Administration said.
Filed by the U.S. Department of Justice's Office of Consumer Protection Litigation and the U.S. District Court of the Eastern District of Wisconsin, the move seeks a consent decree against the Triad Group and H&P Industries of Hartland, Wis., which are accused of violiating good manufacturing standards and failing to heed FDA inspections and warnings about problems with contamination and sterility.
Contaminated products from the firms, which are owned and operated by the same family, have been blamed in lawsuits for serious infections and the death of 2-year-old Harrison Kothari.
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Also See; A Dirty Business: The FDA Wipes Up A Wipemaker
Two months after US Marshals seized a variety of products from a little-known company that was accused of making contaminated medical pads, the agency has filed a consent decree and permanent injunction against H&P Industries and a related company, the Triad Group, along with three executives that will prevent them from making and distributing any over-the-counter products.
Among the products covered by this move are povidone-iodine and benzalkonium chloride antiseptic products, cough and cold products, nasal sprays, suppositories, medicated wipes, antifungal creams, and hemorrhoidal wipes. Not until H&P and Triad can establish “an acceptable” quality assurance and quality control program will the agency allow manufacturing and distribution to ... Continue Reading..
Also See; A Dirty Business: The FDA Wipes Up A Wipemaker
Two months after US Marshals seized a variety of products from a little-known company that was accused of making contaminated medical pads, the agency has filed a consent decree and permanent injunction against H&P Industries and a related company, the Triad Group, along with three executives that will prevent them from making and distributing any over-the-counter products.
Among the products covered by this move are povidone-iodine and benzalkonium chloride antiseptic products, cough and cold products, nasal sprays, suppositories, medicated wipes, antifungal creams, and hemorrhoidal wipes. Not until H&P and Triad can establish “an acceptable” quality assurance and quality control program will the agency allow manufacturing and distribution to ... Continue Reading..
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