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Pharmaceutical

USDA Takes Action Against Drug Manufacturer and Distributor

June 20, 2011
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PRNewswire reports, the U.S. Food and Drug Administration announced that a consent decree of condemnation, forfeiture and permanent injunction has been filed against H&P Industries Inc., The Triad Group Inc., and three individuals that would prevent them from manufacturing and distributing products from their Hartland, Wis., facility, or any other location. The Triad Group distributes and H&P Industries manufactures a variety of over-the-counter drug products including povidone-iodine and benzalkonium chloride antiseptic products, cough and cold products, nasal sprays, suppositories, medicated wipes, antifungal creams, and hemorrhoidal wipes. Under the decree, the defendants cannot resume manufacturing and distributing drugs or medical devices until they establish an acceptable Quality Assurance and Quality Control program to ensure that all products manufactured in their facilities comply with federal standards for quality and have the identity, purity, potency and safety they are expected or are represented to possess. The defendants are required to retain at their own expense an independent current good manufacturing practice (cGMP) expert and develop a work plan that governs their implementation of corrective actions. The defendants cannot resume operations until both their cGMP expert and the FDA determine that they are in compliance with the law. In April 2011, U.S. Marshals, at the request of FDA, seized more than $6 million in products held at the Triad Group and H&P Industries Hartland facility. Under the decree, the seized products are condemned and forfeited to the United States. The defendants, after posting a $4 million bond with the court, may seek FDA''s approval to "recondition" the seized articles. If the defendants'' proposals are unacceptable to FDA, however, the company is obligated to destroy them at its own expense.

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