ROCKVILLE, Md. — The Food and Drug Administration on Monday announced that a consent decree of condemnation, forfeiture and permanent injunction has been filed against H&P Industries, Triad Group and three individuals, which would prevent them from manufacturing and distributing products from their Hartland, Wis., facility, or any other location.
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-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.
“This action is necessary to ensure that the companies operate in full compliance with federal quality standards and do not pose a risk to patients,” FDA’s associate commissioner for regulatory affairs Dara Corrigan said.
FDA inspections from 2009 to 2011 determined that H&P failed to comply with the FDA’s good manufacturing practices regulations, which are intended to assure the safety, quality and purity of manufactured drugs. Since December 2010, H&P has initiated five voluntary product recalls, including two because of bacterial contamination of its products.
The FDA’s most recent inspection of H&P, completed on March 28, found multiple cGMP violations, including continuing problems with an air handling system, failure to adequately investigate drug products that did not meet specifications and failure to take appropriate measures to ensure the quality of incoming components.
In April, U.S. marshals, at the request of the FDA, seized more than $6 million in products held at the Triad Group's 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 the FDA’s approval to “recondition” the seized articles. If the defendants’ proposals are unacceptable to the FDA, however, the company is obligated to destroy them at its own expense.
The decree, filed by the Department of Justice’s Office of Consumer Protection Litigation and the U.S. Attorney’s Office for the Eastern District of Wisconsin, will become effective upon entry by the court.